リソース:中絶ピル






中絶ピル,人口流産薬,Abortion pill,RU-486,Mifepristone,Mifeprex


■個別収録製品

[1091,1493]●mifepristone (Mifeprex Tablet[Population Council])

 日本語版註)mifepristone (Mifeprex Tablet[Population Council])
 【別名】MIFEGYNE;MIFEPRISTONE[INN];RU 38486;RU 486 【開発元】Aventis[前身のRoussel] [DBR_ID]12910
 【化学名】11β-[4-(N,N-dimethylaminyl)]-benzyl-17β-hydroxy-17α-(1-propynenyl)-estra-4,9-diene-3-one ; 11β-[p-(Dimethylamino)phenyl]-17β-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one
 【承認】FDA申請=、FDA承認=18-Sep-96内定→Feb-2000内定→28-Sep-2000[The Population Council]、販売Danco Laboratories;
 【製剤】錠剤-200mg mifepristone  【適応】(70日間迄の子宮内妊娠の中止) MIFEPREX is a progestin antagonist indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation(初承認時Mifeprex is indicated for the medical termination of intrauterine pregnancy through 49 days' pregnancy) 【用法用量】第1日目200mg MIFEPREX、次いでMIFEPREX服用24-48時間後に800 mcg buccal misoprostol
 【作用】 【特徴】 
 【製品情報】■Mifepristone Information 【添付文書】http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020687s020lbl.pdf
 【EU】2000年EU)11か国で解禁 【日本】未開発 【その他】《UK》MIFEGYNE(ROUSSEL UCLAF SA)08-91*∥《FR》MIFEGYNE(ROUSSEL UCLAF SA)-90*



[1091,1392]●mifepristone (Korlym [Corcept Therapeutics ])

 日本語版註)mifepristone (Korlym [Corcept Therapeutics ])
 【別名】 【開発元】Corcept Therapeutics Inc[米国]  [DBR_ID]
 【化学名】11ß-(4-dimethylaminophenyl)-17ß-hydroxy-17α-(1-propynyl)-estra-4,9-dien-3-one
 【承認】FDA申請=15-Apr-2011、FDA承認=17-Feb-2012、米国発売10-Apr-2012 ;
 【製剤】1錠中mifepristone 300mg 【適応】indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. 【用法用量】初回1日1回300mg。 最大1200mg
 【作用】Mifepristone is a selective antagonist of the progesterone receptor at low doses and blocks the glucocorticoid receptor (GR-II) at higher doses. Mifepristone has high affinity for the GR-II receptor but little affinity for the GR-I (MR, mineralocorticoid) receptor. In addition, mifepristone appears to have little or no affinity for estrogen, muscarinic, histaminic, or monoamine receptors. 【特徴】a cortisol receptor blocker 
 【臨床成績】 
 【副作用】 
 【製品情報】www.korlym.com 【添付文書】Korlym -PI
 【提携】 【EU】 
 【日本】未開発 【その他】



[1411]●ミソプロストールMisoprostol (Cytotec [Pfizer])サイトテック錠

 日本語版註)ミソプロストールMisoprostol (Cytotec [Pfizer])サイトテック錠
 【別名】 【開発元】Pfizer  [DBR_ID]13041-232P
 【化学名】methyl(±)- (1R*, 2R*, 3R*)-3-hydroxy-2-[(E)-4-hydroxy-4-methyl-1-octenyl]-5-oxocyclopentaneheptanoate
 【承認】FDA承認=Dec 27, 1988[0.2mg]Sep 21, 1990[0.1mg]、米国発売Feb-1989[Pfizer社G.D.Searle事業部が販売] ;
 【製剤】Cytotec oral tablets contain either 100 mcg or 200 mcg of misoprostol
 【適応】Cytotec (misoprostol) is indicated for reducing the risk of NSAID (nonsteroidal antiinflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer.
Cytotec has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Cytotec should be taken for the duration of NSAID therapy. Cytotec has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months’ duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.
 【用法用量】通常、成人にはミソプロストールとして1回200μgを1日4回(毎食後)経口投与する。
 【作用】
 【特徴】1.非ステロイド性消炎鎮痛剤の長期投与に伴う胃及び十二指腸潰瘍に対する適応が承認された初めての薬剤である。
2.臨床用量において,基礎,刺激及び夜間酸分泌の抑制作用とともに,胃粘膜血液量の増加,重炭酸イオン分泌の増加等の作用を示す。すなわち,攻撃因子の抑制作用と防御因子の増強作用とを併せ持つ。
3.シメチジン(H2受容体拮抗剤)及びスクラルファート(胃粘膜保護剤)が効果を示さない胃粘膜傷害惹起物質(無水エタノール,胆汁酸,塩酸等)による胃粘膜傷害に対して抑制効果を示す。
4.非ステロイド性消炎鎮痛剤の継続投与下で,胃潰瘍に対する内視鏡判定治癒率は65.7%(44/67例),有用率は76.4%(55/72例)であり,十二指腸潰瘍に対する内視鏡判定治癒率は83.3%(5/6例),有用率は66.7%(4/6例)であった。
5.H2受容体拮抗剤治療抵抗性の胃潰瘍に対し,非ステロイド性消炎鎮痛剤継続投与下において,治癒効果を示す(治癒率52.9%)。
6.副作用は調査症例数4,692例中545例(11.6%),766件に発現し,その主なものは,下痢・軟便227件(4.8%),腹痛92件(2.0%),腹部膨満感57件(1.2%),嘔気52件(1.1%)等であった。また,重大な副作用としてショック,アナフィラキシー様症状(頻度不明)が報告されている。 
 【臨床成績】 
 【副作用】 
 【製品情報】CYTOTEC 【添付文書】CYTOTEC U.S. Physician Prescribing Information
 【提携】 【EU】2013年2月現在、約80ヵ国で承認・発売されている。 CYTOTEC:瑞1985年9月発売、豪1986年4月発売、仏1987年8月発売、英1988年9月発売、米1989年2月発売、伊1989年12月発売 
 【日本】サイトテック錠100,200[発売/科研製薬株式会社 製造販売/ファイザー株式会社]Cytotec 承認1993年1月19日[200]1996年6月21日[100] 薬価収載1993年3月19日[200]1996年12月13日[100] 発売1993年3月25日[200]1996年12月13日[100] 国際誕生年月1984年6月 【製剤~日本】1錠中ミソプロストール 100μg ,200μg  【適応~日本】非ステロイド性消炎鎮痛剤の長期投与時にみられる胃潰瘍及び十二指腸潰瘍  【用法用量~日本】通常、成人にはミソプロストールとして1回200μgを1日4回(毎食後及び就寝前)経口投与する。なお、年齢、症状により適宜増減する。 【製品情報~日本】サイトテック錠 【添付文書~日本】サイトテック錠 - インタビューフォーム 【その他】
 【開発の経緯】
ミソプロストールは1973年米国G.D.サール社(現,米国ファイザー社)により“胃酸分泌抑制作用が強く,経口投与で活性を有し,作用時間が長い”ことを目標として合成されたプロスタグランジンE1誘導体である。ミソプロストールはそのままでは化学的に不安定なため,ヒドロキシプロピルメチルセルロースに分散させた“ミソプロストール分散体”を原体として,室温で長期間安定なサイトテック錠200を製することに成功した。本剤は,胃酸分泌抑制作用のみならず,強酸,強塩基及び無水エタノール等の壊死惹起物質による上部消化管傷害の防御,胃粘膜血液量の増加,重炭酸イオンの分泌増加及び粘液分泌の増加等の粘膜保護作用(サイトプロテクション作用)を併せもち,1981年より国内臨床試験が開始された。その結果,非ステロイド性消炎鎮痛剤(NSAID)投与時にみられる胃及び十二指腸潰瘍患者に対して優れた治療効果を示すことが認められ,1993年に承認を得て発売に至った。また,本剤は高齢者を適応疾患の対象とする場合が多く,個々の症例に合わせてより一層用量調節をしやすくするために,従来の半分量を含有するサイトテック錠100が開発され,1996年に承認を得た。
また,3,646例の使用成績調査を実施し,1999年4月に再審査申請を行った結果,2002年9月に薬事法第14条第2項各号(承認拒否事由)のいずれにも該当しないとの再審査結果を得た。
2003年10月現在,世界約90ヵ国で承認・発売されている。






【日本語版コメント1493~ミフェプリストン(Mifeprex)のラベル変更/2016.04.25】
 2016年3月29日FDAはmifepristoneによる中絶を従来の49日以内の妊娠期間から70日以内への延長を承認した。

【日本語版コメント1411~自然流産薬ミソプロストール/2013.03.04】
Misoprostol(抗潰瘍薬)とmifepristone(日本未開発)は、WHO Essential medicinesとして指定され、unsafe abortion(安全でない流産)を防ぐためにWHOから推奨されている。

【日本語版コメント1392~クッシング症候群の治療薬ミフェプリストン(Korlym -Corcept Therapeutics)/2012.6.11】
 クッシング症候群は,血中のコルチゾルまたは関連するコルチコステロイドの慢性高値によって引き起こされた一群の臨床異常である。クッシング病は下垂体のACTH過剰産生に起因するクッシング症候群で,通常は下垂体腺腫に続発する。 日本では平均して年に約100症例が新規クッシング症例として診断され、そのうち約50%が副腎性、40%程度がクッシング病と考えられている。 最近公費対象の特定疾患に指定され、交付件数は、間脳下垂体機能障害(PRL分泌異常症、ゴナドトロピン分泌異常症、ADH分泌異常症、 下垂体性TSH分泌異常症、クッシング病、先端巨大症、下垂体機能低下症)として平成22年度11,764件。
 日本ではミトタン(オペプリム[ヤクルト本社)、トリロスタン(デソパン錠60mg[持田製薬])、メチラポン(メトピロンカプセル250mg[ノバルティスファーマ])の3製品がクッシング症候群の適応を承認されている。


【日本語版コメント1091~ミフェプリストン(RU486)/2000.10.30】
 米国FDAで、注目のAbortion pill(中絶ピル) Mifeprix (RU-486)が2000.9.28、ついに正式承認された。 同剤はフランスで1988年承認されたのが最初で、英国、スェーデン等13か国で承認され、11年間で62万人の女性に使用されているが、米国ではカトリック系宗教団体を含む保守系団体が人工中絶を促進するとして反対。 開発元ルセル社(現アベンティス)は政治的事態に巻き込まれるのを怖れて米国開発を断念していたが、民間ボランティア団体Population Council(家族計画・女性の権利を推進)が開発を継承、販売はダンコ社(Danco Labs)が行う。
 ピル推進派によると、ミフェプリストン売上は年間1億ドル(1回$80、43万女性として)との推計もされているものの、仏、英、スェーデン3か国の1996年度売上合計は3500万ドル。
 使用には厳しい制約が要求されている。




【解説資料】
Mifepristone The French Abortion Pill The

【リソース】
MEDLINEplus: Reproductive Health (General)

【主要サイト】
Population Council | Mifeprex™ (Mifepristone) Early Option Pill 製品情報サイト|Mifeprex Labeling★添付文書
The Early Option Pill 製品情報サイトby Danco Laboratories|Product labelling※添付文書








●解説












●データ












●臨床ガイドラインなど












●総説記事・文献


Mifepristone The French Abortion Pill The

Mifepristone The French Abortion Pill The "Anti-Pregnancy" Pill Mifeprex Abortion by Pill RU486 ru-486 mifegyne M & M RU 486 Miracle Pill The Abortion Pill non-surgical abortion the "Easy" Abortion makes the baby go away ru486 UNPREGNANCY
Contragestion Chemical Abortion RU 38486 Medical Abortion ru 486 Mf
RU486: The Pill, The Process, The Problems
What is RU486?
How does RU486 work?
Is this the "morning after" pill?
What is the baby like at this time?
Does RU486 have any other, non-abortifacient, uses?
Why does a typical RU486 abortion involve a second drug, misoprostol?
How long does it take and how many steps?
What medical conditions may keep a woman from being offered RU486?
Is RU486 really "safe" and "effective?"
Didn't an Iowa woman in the U.S. RU486 trials nearly bleed to death?
What other physical side effects are common?
Are there any long term physical consequences?
Are chemical abortions safer than surgical abortions?
What about psychological after effects?
Bringing RU486 to the U.S.
With all these problems, why did the FDA recommend approval?
Is this the way the drug approval process is supposed to work?
Has the FDA ever approved a drug like this before?
With all the help from the Clinton administration, what held up approval?
Why has the Population Council had difficulty finding or keeping a manufacturer?
Wasn't there a pro-life consumer boycott of Roussel Uclaf's American subsidiaries?
The Companies Involved
Who is the French company that created RU486 and how is it tied to other pharmaceutical firms?
What corporate entities has the American patent holder set up to manufacture and distribute RU486?
Did Roussel Uclaf's U.S. involvement with RU486 end with the 1994 donation of the patent?
Who currently controls the RU486 patent in Europe and elsewhere?
The Rest of the World
What European countries have recently approved the sale of RU486?
Do the abortion pill's promoters intend to export this drug to Third World countries?
Considering the bleeding and other risks, isn't this a dangerous idea?
Why an abortion pill?
Why does the pro-abortion crowd want the abortion pill?

RU486: The Pill, The Process, The Problems
What is RU486?
RU 486 is a chemical compound that, taken in pill form, can induce abortion in women up to nine weeks pregnant. This compound gets the first part of its name from the French company, Roussel Uclaf, which first developed the abortion pill back in 1980. The "486" designation is the shortened version of the original "38486" compound number the pill was first assigned in the Roussel Uclaf laboratory.(1)
RU486 is also known by its generic name, mifepristone, and by Mifegyne, the name under which RU486 is marketed in Europe.(2)
Mifeprex is the name under which it is to be sold in the United States.(3)

How does RU486 work?
RU486 is an artificial steroid that interferes with the action of progesterone, a hormone crucial to the early progress of pregnancy.(4)
Progesterone stimulates the proliferation of the uterine lining which nourishes the developing child. It also suppresses normal uterine contractions which could dislodge the child implanted and growing on the wall of the mother's womb.(5)
RU486 fills the chemical receptor sites normally reserved for progesterone, but does not transmit the progesterone signal. Sensing what appears to be a drop in progesterone, usually a sign that pregnancy has not occurred, a woman's body shuts down the preparation of the uterus and initiates the normal menstrual process. The child, deprived of necessary nutrients, starves to death. The baby detaches and is swept out of the body along with the decayed uterine lining.(6)

Is this the "
morning after" pill I've heard so much about?

No. Those pills operate in a different way and during a different time frame than RU486.
Morning after pills, or "emergency contraception," are essentially very high, multiple dosages of birth control pills taken within 72 hours of unprotected intercourse.(7), (8)
While there have been some limited tests of RU486 as a morning after pill, with mixed results,(9) the only purpose for which the U.S. sponsor has sought government approval is for use to abort a confirmed pregnancy(10), (11) weeks after the baby has already attached him or herself to the uterine wall.(12)

What is the baby like at this time?
During the time frame that RU486 is operative, the baby is undergoing a rapid period of development.
It is at about the fifth week of pregnancy (measured from a woman's last menstrual period) that a mother first begins to suspect she is pregnant, so this is likely to be about the earliest that the chemical abortifacient is used. At this point, the child is about three weeks old(13) and approximately 2mm long (about 1/10 of an inch).(14)
Even by this time, however, the baby's nervous system has begun to form(15) and his or her heart is likely to have already begun its first beats.(16)
The child's heart will be beating strongly and steadily by the time he or she is just three and a half weeks old..(17)
The effectiveness of the RU486, or mifepristone, method begins to decline after 49 days, or 7 weeks of pregnancy.(18) By that time, the baby will be five weeks old and will have increased in size to 8mm, and his or her face, arms, and legs will be distinguishable.(19)
Before the end of the 9th week of pregnancy (7 weeks for the baby), the outer extreme of mifepristone's effectiveness,(20) the child's ears, fingers and toes will have formed and he or she will be 18mm, or nearly an inch tall, from crown to rump.(21)

Does RU486 have any other, non-abortifacient, uses?
While researchers have proposed a long list of diseases and conditions that RU486 might be useful against, and in some cases, conducted limited testing, the only purpose for which the U.S. sponsor has pursued government approval is abortion.(22)
Because of its properties as a antiprogestin (a compound that inhibits the action of the hormone progesterone), some believe that it may be helpful in treating endometriosis, fibroids, breast cancer, and certain non-malignant brain tumors called meningomas.(23) Pro-life groups such as the National Right to Life Committee have never opposed the testing or use of RU486 for such therapeutic purposes, but evidence of its effectiveness in these applications,(24) as well as evidence of the pill's promoter's real interest in such applications, is limited .(25)

Why does a typical RU486 abortion involve a second drug, misoprostol?
Acting alone, RU486 is able to induce an abortion only between 64% and 85% of the time, a rate abortifacient researchers consider "inadequate for general clinical use."(26) This is why, two days after taking the RU486, a woman is given a prostaglandin, usually misoprostol (trade name: Cytotec), to induce powerful uterine contractions to expel the shriveled corpse.(27) Because the use of a prostaglandin (PG) is part of the standard RU486 abortion protocol, it is perhaps more accurate to refer to this as an "RU486/PG" abortion.

How long does a typical RU486/PG abortion take and how many steps does it involve?
An RU486/PG induced abortion can take days, weeks, or never happen at all. It typically involves 3 (or more) visits to the doctor's office over a two week period.
In her first visit, a woman is "counseled," given a physical examination, perhaps an ultrasound, and if there are no obvious contraindications (common red flags such as high blood pressure, diabetes, heavy smoking, allergies, etc. that could make taking the drug deadly or dangerous for her(28)), she is given the RU486 pills, which she takes in the presence of the abortionist.
Two days later, during a second visit to the doctor's office, she is given the prostaglandin, which she takes orally or has inserted vaginally. Gradually, as the drug begins to take effect, she experiences powerful, painful uterine contractions which begin to work to expel the baby.
In U.S. trials, about half (49%) aborted during the four hours they spent waiting in the doctor's office following the administration of the prostaglandin. An additional 26 % aborted sometime over the next 20 hours, on the bus ride home, at work, in the shower, etc. The rest who aborted did so at some point during the following two weeks. Between 8% and 23% (depending on how many weeks pregnant the mother was) never completely aborted or didn't abort at all using the drugs.
A third visit some 14 days from the woman's initial visit allows the doctor to confirm whether or not the abortion has been completed. If it hasn't, the abortionist will encourage the woman to undergo a surgical abortion to guard against the possibility that she will give birth to a child who may have been injured by the drugs.(29), (30)

What sort of medical conditions might keep a woman from being offered the chemical abortion method?
Despite public claims of its ease and safety, the RU486/PG abortion method comes with a long list of contraindications, i.e., conditions that doctors believe should disqualify a woman from using the method or should at least call for heightened caution and monitoring among those selecting patients and administering the drugs because of the increased medical risks faced by such women.
Abortion researchers have recommended that women with adrenal failure, severe asthma, or receiving long-term glucocorticoid therapy not be given the drugs. Those same researchers recommend that the drugs be used cautiously in women with complicated diabetes mellitus, severe anemia, hemorrhagic [bleeding or clotting] disorders, or receiving treatment with anticoagulants. A prostaglandin sometimes used with RU486, sulprostone, has been associated with heart failure in women who were over 35, obese, smoked, or had other cardiovascular risk factors, though these have not yet been reported with the prostaglandin misoprostol.(31)
Other conditions that previous researchers have considered sufficient grounds to exclude women from clinical trials of the drugs include high blood pressure, bronchitis, menstrual irregularity, fibroids, endometriosis, use of IUD or oral contraceptives (in past three months), history of problem pregnancy, current ectopic pregnancy, pelvic inflammatory disease, allergies, epilepsy, adrenal insufficiency, recent intake of steroid or anti-inflammatory medication, or a history of liver, stomach, or intestinal disease.(32)

The FDA declared RU486 "safe" and "effective." Is it really?
It certainly isn't safe for the baby who suffocates or starves to death.(33)
And it strains credulity to label a drug that puts perfectly healthy women in the hospital and may not work nearly a quarter of the time"safe" and "effective."(34)
Despite careful screening to eliminate all but the most physically ideal candidates, 2% of those participating in U.S. trials of RU486 hemorrhaged.(35)
One out of a 100 had to be hospitalized.(36)
Several women required surgery to stop the bleeding and some bled so much that they had to have transfusions.(37) In the broader, less regulated medical marketplace, outside the careful monitoring of a clinical trial, complications could be expected to be both more common and more serious, especially for those women who do not have immediate access to emergency care.(38)
While tests in France yielded a 95-96% "success" rate,(39) the success rate in American trials for the two drug procedure has been considerably lower. Women in their fifth week of pregnancy aborted 92% of the time, while women in their seventh week aborted 77% of the time.(40)
Outside the strict conditions of a clinical trial, reduced screening, monitoring, and compliance is likely to increase the "failure" rate.(41)
Didn't an
Iowa woman participating in the U.S. trials in 1994 nearly bleed to death?
Yes. According to Mark Louviere, the doctor who treated the woman, she lost between one-half to two thirds of her total blood volume and probably would have died if she had not had emergency surgery.(42)
The doctor came forward after reading a press report that the Iowa portion of the trials had ended with "no complications"among the 238 women there who took part in the test.(43) "If near death due to the loss of half of one's blood volume, surgery, and a transfusion of four units of blood do not qualify as a complication," Louviere told the Waterloo Courier, "I don't know what does."(44)

What other physical side effects are common?
Nausea, diarrhea, vomiting, and painful cramping are quite often part of the package, and sometimes in clinical trials were themselves severe enough to put women in the hospital.(45) Less frequent, but potentially more serious, are side effects such as infection(46) or heart palpitations.(47)
Are there any ● long term physical consequences? This is simply unknown at this point. It is known that RU486 crosses the blood follicle barrier and gets into the follicular fluid surrounding a woman's ripening eggs.(48) What impact this will have on future pregnancies, or on children born later on, has not yet been adequately researched.

Are ● chemical abortions safer than surgical abortions?
Both chemical and surgical abortions have their risks, and it is not clear that they are directly comparable.
Promoters of the abortion pill often speak as if RU486/PG abortions are safer because they are earlier abortions.(49) While it is true that earlier surgical abortions are safer than later surgical abortions,(50) owing to the increasing size of the baby and the increasing complexity of the surgical procedure,(51) it isn't clear that early chemical abortions are necessarily safer than later surgical abortions. Because the methods are so different, this is like comparing apples and oranges.
With surgical abortions, a woman faces the risks of cervical lacerations,(52) uterine of bowel perforations,(53) scarring, infection, and even permanent infertility.(54)
These risks, due to the surgical process itself, may be avoided in a chemical abortion (provided a woman is not in that 8%-23% for whom the method fails(55)).
But the woman undergoing a chemical abortion faces a whole new set of risks, ranging from hemorrhage(56) to heart failure,(57) typically not faced by the surgical patient.
Variations in the severity and frequency of these complications make it difficult to identify one method as safer than another. Significant injury or worse is possible with either method.

What about
psychological after effects?
Though no long term studies have yet been done, the descriptions women give of their encounters with their aborted children raise great concern. Women who have undergone RU486/PG abortions talk about seeing tiny fists, eyes, or seeing their aborted babies laying in the toilet bowl or swirling in the shower drain.(58)
Counselors at abortion clinics indicate it is common for women to express a desire to bury the baby, to perform some sort of ceremony to deal with their strong feelings.(59) These are hardly the reactions of women who consider this a blob of tissue.(60)
Whereas those who undergo surgical abortion only imagine what their unborn children look like and go through, women who have abortions with RU486 have vivid memories of their encounters with their children.(61)
And while giving the woman more control over her abortion may assuage the abortionist's guilt, it definitely increases a woman's sense of responsibility for the abortion.(62)
While a sense of relief is what many woman having surgical or chemical abortions feel immediately after the abortion, we know from experience that the symptoms of post abortion trauma often do not show up until years later.(63) When women who have had RU486 abortions begin to deal with their experience, they will have more vivid memories and a greater sense of responsibility to deal with than those who underwent surgical abortions.


Bringing RU486 to the U.S.

With all these problems, why did the FDA recommend its approval in the first place?
Good question. Under the Bush administration, the FDA issued an import alert, prohibiting the import of the drug for personal use because of safety concerns it had about the drug.(64) Three days after being sworn into office, President Bill Clinton signed an executive order directing the Department of Health and Human Services and the FDA to take steps to promote the testing, licensing, and manufacturing of the drug in the U.S.(65)
Under the Clinton administration, the FDA took a very active role in efforts to bring the drug into the U.S. In the course of carrying out the president's directive, the FDA:
* actively pressured French manufacturer Roussel Uclaf to submit a marketing application.(66)
* helped negotiate the transfer of manufacturing and marketing rights from Roussel Uclaf to the Population Council of New York once it became clear Roussel Uclaf would not submit an application of its own.(67)
* allowed the Population Council to use data from foreign studies in its marketing application, rather than require the Council to wait until it was ready to submit data from American studies.(68)
* allowed to Population Council to submit its marketing application despite not having a finalized deal with any manufacturer or any finished chemical product from its would-be manufacturer.(69) The FDA allowed the Population Council to use chemical and manufacturing data from Roussel Uclaf as the basis of the Council's application, knowing that Roussel Uclaf would not be the manufacturer.(70)
* submitted the application to an advisory panel stacked with known abortion activists and RU486 supporters.(71)
* processed the application for RU486 in just six months, while potentially life saving drugs were taking as long as 17 months to be processed.(72)
Is that the way the drug approval

process is supposed to work?
Hardly. The Food and Drug Administration is supposed to be an objective agency representing the health and safety interests of the American people,(73) not an agent for some manufacturer or some group with an ideological or political agenda.
Has the FDA ever approved a drug like this before?
No, never. While there have been drugs, such as pain medications, that might hasten death at certain doses, or other drugs which, if misused, could cause death, if RU486 is approved, it will represent the first time in our nation's history that our government has ever approved a drug for the specific purpose of taking the life of another human being.
With all that help from the

Clinton administration, what kept the drug from being approved right away?
Perhaps even the FDA could only bend the rules so far. Having questions about the training program(74) and lacking any drug sample or file from the firm that was to be the manufacturer,(75) the best the FDA could do by the time its deadline came to rule on the drug application was to issue an "approvable" letter, declaring that they were satisfied the drug was "safe" and "effective," but saying final approval would await the resolution of certain unnamed "labeling" and "manufacturing" issues.(76)
Soon after the FDA issued its "approvable" letter in September of 1996, the Population Council and Joseph Pike, the man chosen by the Council to set up U.S. production of RU486 and handle financing of the project, became embroiled in controversy when would-be investors discovered in October 1996 that Mr. Pike was a disbarred lawyer with a criminal record.(77)
These investors were also concerned about the unusual corporate structure Pike established and the integrity of his financial dealings and operations.(78)
A series of suits and countersuits between the Population Council, Mr. Pike, and the would-be investors ensued,(79) tying the drug's sponsor up in court for several months and bringing unwanted negative publicity to the Population Council and the RU486 project.(80)
Just as those suits began to be resolved in the spring of 1997,(81) removing Pike from day to day management of the project, the Population Council received word that the Hungarian manufacturer, Gedeon Richter, that they had lined up to produce the drug for the United States, was pulling out of the deal.(82)
Gedeon Richter gave no public reason for its withdrawal, but their pull out forced the Population Council to have to begin their search for a manufacturer all over again, setting back the project several years.(83)
The Population Council announced that it had found new manufacturers in early 1999 and predicted it would forward the information to the FDA needed to resolve outstanding issues on its application and have the drug on the American market by the end of the year.(84)
While the Council did forward data to the FDA sometime in 1999,(85) the FDA apparently did not find the response sufficient to warrant final approval. Instead, the FDA issued another "approvable" letter in
February of 2000, confirming that the application was still active, but indicating there were still "remaining questions" to be resolved.(86)
While the Population Council admitted that these were, once again, "manufacturing" and "labeling" issues requiring resolution, neither the FDA nor the Council gave further details as to what those outstanding labeling or manufacturing issues entailed.(87)

Why has the
Population Council had such difficulty finding or keeping a manufacturer?
Early on, a spokesman for the Population Council indicated that several of the major drug companies they had originally talked to didn't want to face the internal dissension that producing such a pill would bring.(88) This is not surprising. Who, having devoted their life to the production of life-saving medicines, wants suddenly to be associated with a drug that kills little children?

Companies may also have looked at what becoming "the abortion pill company" might do to their corporate image and bottom line.(89) As a product, RU486 offers relatively low profit potential against a rather hefty financial risk.

Unless abortion increases dramatically, the absolute maximal market is only about 1.2 to 1.3 million women a year (the number of abortions performed annually in the U.S.), with these women purchasing no more than three pills at a time. Even here, two-thirds to four-fifths of these women are not likely to be eligible to receive the drug because of the date of their pregnancies (over 7 weeks) or because of other disqualifying medical or physical conditions.(90)

 ピル推進派によると、ミフェプリストン売上は年間1億ドル(1回$80、43万女性として)。 仏、英、スェーデン3か国の1996年度売上合計は3500万ドル。
The pill's promoters have spoken of potential revenues from mifepristone sales as high as $100 million a year,(91) yet, at $80 a dose,(92) with a potential customer base of only about 430,000 women (see above), the most a company might realistically expect to take in from sales of RU486, before subtracting manufacturing costs or other expenses, would be only about $35 million a year. Even this number may be grossly inflated. Sales of mifepristone in France, Britain, and Sweden for 1996 combined totaled only $3.44 million.(93)
It is hard to imagine any of the major pharmaceutical makers risking its corporate image and billions of dollars of sales(94) from its most popular products for such a relatively modest gain and the likelihood of an ongoing public relations nightmare.(95)
See also comments of Hoechst spokeswoman Catherine Euvrard in Joseph Schuman, "Firm Gives Up Rights to RU-486," Washington Post, April 9, 1997, p. C12.
Add to that the enormous liability risk(96) if just one of those women suffers permanent injury or bleeds to death,(97) and association with the abortion pill becomes an increasingly unattractive option to any manufacturer tempted to take on the drug.
Wasn't there a
pro-life consumer boycott of Roussel Uclaf's American subsidiaries?
The National Right to Life Committee (NRLC) and its pro-life allies launched a consumer product boycott of Roussel Uclaf's American subsidiaries in 1994.
People ordered tens of thousands of postcards from NRLC to send to Roussel's subsidiaries to protest Roussel's collusion in efforts to bring RU486 to the U.S.(98)
One week after NRLC published an advertisement in USA Today highlighting the consumer boycott of Allegra,(99) one of Hoechst Marion Roussel's top sellers, Roussel Uclaf announced it was stopping European production and giving up all remaining rights to the drug. Hoechst AG, the parent company of both Roussel Uclaf and their joint drug conglomerate, Hoechst Marion Rousssel, told the Wall Street Journal that "its decision to transfer RU-486 production was already in the works, thanks to similar pressure, but admitted the boycott threats had an impact." Speaking directly, a spokeswoman from Hoechst told the Wall Street Journal, "Hoechst cannot take the risk of a U.S. boycott."(100)

The ● Companies Involved
Could you briefly explain all the companies that are involved or have been involved in the production of RU486? It all seems so confusing.
It is confusing, but we'll try. The blanket of secrecy with which the Population Council has tried to cover all of its activities, as well as all the mergers and acquisitions going on in the world pharmaceutical market, make it difficult to determine precisely who is doing what.
What is the name of the French company who created RU486 and how is it tied to other chemical and pharmaceutical corporations?
Roussel Uclaf is the French pharmaceutical company which first developed RU486 in the early 1980s.(101)
They were owned, first partly, then later, wholly, by German chemical giant Hoechst AG.(102) Together, Roussel and Hoechst owned several American subsidiaries - Hoechst Roussel Pharmaceuticals,(103) Copley Pharmaceutical,(104) and Hoechst Roussel Agri-Vet.(105)
Under pressure from the U.S. government, Hoechst and Roussel donated the American patent for RU486 to the Population Council of New York in 1994.(106) Roussel retained all remaining rights (those outside the U.S.) to RU486 and continued to manufacture the drug for European use until at least 1997.(107)
In 1995, Hoechst purchased American drug manufacturer Marion Merrell Dow (MMD), forming a new pharmaceutical company Hoechst Marion Roussel (HMR),(108) then supposed to be the world's third largest pharmaceutical maker.(109)
As part of the acquisition, HMR acquired several of Marion Merrel Dow's best selling drugs such as Cardizem and Seldane, as well as rights to a new non-sedating antihistamine being developed by MMD called Allegra. HMR also got MMD's manufacturer of generic drugs, the Rugby Group.(110)
HMR sold off The Rugby Group in 1998(111) and Copley Pharmaceuticals in 1999.(112)
In 1999, Hoechst and HMR merged with another European pharmaceutical giant, Rhone Poulenc, to form Aventis.(113)

What about the ● American group who received the patent? What corporate entities has it set up to manufacture and distribute the abortion drug?
After receiving the U.S. rights to RU486 from Roussel Uclaf and Hoechst AG in 1994, the Population Council, working with a lawyer/entrepeneur by the name of Joseph Pike, set up a series of companies to handle various aspects of the production, distribution, and marketing of RU486.
Pike and the Council first established a non-profit called Advances in Health Technology to promote the drug and provide public education and handle doctor training.(114) Advances also received the license to manufacture and distribute mifepristone which it turned around and granted as sub-licenses to two other for profit companies set up by Pike, Danco Laboratories and Neogen Pharmaceuticals, Inc. Though neither was to be the actual manufacturer, Danco was supposed to be responsible for setting up the manufacturing and distribution of mifepristone as an abortifacient while Neogen was to arrange manufacturing and distribution of the drug for all other medical indications.(115)
Pike controlled both of the sub-licensees through a company called N.D. Management.(116) N.D. Management, in turn, was the sole general partner of a Neogen Investors and a limited partner, along with Neogen Investors, in a group named Neogen Holdings, L.P. Neogen Holdings was the sole shareholder of Danco, while Neogen Investors was the sole shareholder of Neogen Pharmaceuticals.(117)
Outside investors thus gained some stake in both the abortifacient and non-abortifacient uses of mifepristone through their participation in Neogen Investors.(118)
Some confusion about the names of the various entities involved in the mifepristone project arose when Pike kept changing the name on the bank account in which cash proceeds from the Neogen Investors offerings were held. From 1995 to 1996, the name on the account was changed four times, from Neogen to Neogen Pharmaceuticals to Neogen Industries to Neogen Pharmaceuticals to Neogen Industries again.(119)
Pike was exposed as a disbarred lawyer and convicted forgerer in October 1996, leading to a series of lawsuits between the Population Council, Pike, and would-be investors. In announcing the settlement of suits between Pike and the Population Council, removing Pike from the project's day to day operations in February of 1997, the Council also announced a change in the project's corporate structure.
Advances in Health Technology, the non-profit which originally held the license for manufacturing and distributing mifepristone, was eliminated and replaced by a new company Advances for Choice, headed by Dutch former pharmaceutical executive Jack Van Hulst. Advances for Choice was supposed to pick up the training and education functions performed by Advances in Health Technology, and was to be publicly identified as RU486's U.S. seller and distributor. The identities of the manufacturer and other involved companies were still to be kept secret.(120)
Court documents filed in May of that year, however, showed that Danco, the sublicensee charged with arranging the manufacturing and distribution of RU486, continued to exist, along with Neogen Investors, the group of investors putting money into the abortion pill project, and N.D. Management, the entity set up by Pike to oversee all aspects of the project handled by Danco and the various Neogen incarnations. Those documents further clarified that Danco was simply supposed to be the "marketer/seller of the finished product," with other unnamed companies responsible for manufacturing the raw product and pressing it into tablet form.(121)
The name of the company the Population Council had originally contracted in 1996 to manufacture the raw mifepristone, Hungarian pharmaceutical firm Gedeon Richter, also surfaced in June of 1997, when the press learned through those same court documents that Richter had notified Danco and the Population Council of its intention to pull out of the deal at the end of February 1997.(122) Danco sued Richter in May to try to force Richter to fulfill the contract; the case and the identities of the litigants became known when a New York judge refused to seal the records.(123)
In the process of responding to press inquiries about the case and its implications for the timing of the abortion pill's release, spokespeople for the Population Council let it be known that the name of the marketing arm had been changed once again, from Advances for Choice to Advances/Neogen, with the status of Jack Van Hulst, the gentleman originally tapped to be the CEO of Advances for Choice, in limbo.(124) Whether the new name represented a melding of the marketing, management, and investment functions, or a further joining of the abortifacient and the putative non-abortifacient divisions of the mifepristone project, the Council did not say.
A 1998 document referred to the Council's licensee as Advances/The Neogen Group, though it is unclear whether this represented any further change or simply a variation on the latest designation.(125)
Reports appearing in 1999 and 2000 have referred to the Danco Group, rather than Advances/Neogen, as "the company licensed to to market RU-486" or the "company sponsoring mifepristone in the United States."(126) Other reports vary the name, referring to this company as "Danco Laboratories,"(127) or Danco Laboratories, LLC.(128)
Mother Jones magazine indicates that the Danco Group received this license in 1998. While articles have identified the Danco Group as "a start-up pharmaceutical company" in New York(129) (the original Danco Laboratories was set up in California(130) and incorporated in the Cayman Islands(131)), these reports and others suggest that other unnamed firms are the actual manufacturers.(132)
Did
Roussel Uclaf's involvement with RU486 in the United States end when it donated the patent to the Population Council in 1994?
Hardly. Court documents that came to light in 1997 reveal that despite Roussel Uclaf's claim that its donation of patent to the Population Council in 1994 "eliminates its involvement in the manufacture and distribution of RU 486 in the U.S.,"(133) Roussel did several things to assist the U.S. mifepristone project after giving the U.S. patent to the Population Council.
Despite its claims of non-involvement, RU:
* supplied the pills used in the U.S. clinical trial conducted by the Population Council in 1994 and 1995.(134)
* functioned as the "stand-in" manufacturer on the Population Council's marketing application to the FDA in 1996, supplying the Chemical, Manufacturing, and Control section of the Council's marketing application, because the Council had yet to sign a firm contract with a manufacturer or obtain any product samples from a new manufacturing source.(135)
* furnished Gedeon Richter, the Hungarian firm that was to be the manufacturer of the drug for the Population Council, with Roussel's complete Drug Master File (DMF) on mifepristone and contacted Richter directly "to offer any assistance it needed in completing its own DMF."(136)
Who now
controls the patent rights in Europe and other places outside the U.S.?
Roussel Uclaf, which gave away the U.S. patent to the Population Council in 1994, transferred its remaining RU486 rights (those outside the U.S.) to Edouard Sakiz, one of Roussel's former chief executives, in April of 1997.(137)
Sakiz, who ran Roussel Uclaf back when RU486 was first developed and sold on the French market,(138) set up a new company, Exelgyn, to handle manufacturing, marketing and distribution of the drug. Though Roussel claimed that it was "ending its involvement with mifepristone" with the April 1997 transfer,(139) Hoechst [through Roussel Uclaf] continued to produce the pill while Sakiz was setting up his company and arranging for other companies to do the production and distribution.(140)
Roussel Uclaf is supposed to have actually stopped production and turned over its remaining stocks to Exelgyn in September of 1997.(141)

The ● Rest of The World
What European countries have recently approved the sale of RU486?
Until recently, only France, Britain, and Sweden offered the drug. However, in 1999, mifepristone was approved for use in several new European countries.
In April of 1999, Exelgyn asked the European Drug Agency, which oversees drug approvals for member countries of the European Union (EU), for permission to put the drug on sale in eight of the 12 remaining EU countries.
Those countries were Austria, Belgium, Denmark, Finland, Germany, Greece, Spain, and The Netherlands.(142)
Exelgyn chose not to apply to market the drug in Italy, Ireland, Luxembourg, and Portugal.(143)
Members of the EU have mutual recognition procedures whereby the drug authorizations of one country can be extended to others,(144) and it was under this procedure Exelgyn sought clearance in these eight countries. That was granted July 6, 1999. National governments in Germany, Greece, Belgium, and Finland had already given notification of permission for sale of the pill in their countries, while individual governmental notification was still pending in Austria, Denmark, Spain and the Netherlands at that time.(145)
Reports also indicate that Israel recently granted a license to the abortifacient,(146) and that Exelgyn also registered the drug in non-EU countries Switzerland and Russia.(147) Exelgyn is also said to be prepared to apply for registration in Canada once the drug receives final approval in the U.S.(148)
Even where the abortion pill has full government approval, supply, training, and distribution issues still remain to be worked out, a task made all the more difficult in those countries with institutional opposition and complex nationalized health care bureaucracies.(149)

Do the
abortion pill's promoters have any intent to export the drug to third world countries?
Yes. The export of RU486 to the world's developing countries has been in the minds of the pill's developers and promoters from the very beginning.

Even before discovering RU486 and its unique abortifacient properties, Emile Baulieu admits he was looking for some way to deal with the "demographic," i.e., population, "crisis" of so-called Third World countries.(150) Baulieu's vision had not changed in 1990 after seeing the drug approved in France, Britain, and Sweden. In his history of RU486, The "Abortion Pill," Baulieu declared that, in developing countries, "Women badly need the [contraceptive] backup methods of effective contragestion and abortion. RU-486 has a vital role to play." Beyond personal medical benefits Baulieu projected for the drug, Baulieu indicated he also believed RU-486 had a "broader role" in such countries helping "governments to dampen a population explosion which threatens to outstrip the world's resources."(151)

Though authorized development and distribution has, so far, been in largely western nations (China being the exception), the hope among abortion pill advocates is that U.S. approval will springboard RU486's acceptance in other nations around the globe who look to America for guidance.(152)

Delegates from Kenya, India, South Africa, Cuba, Vietnam and others countries met in January of 1998 with representatives of Exelgyn and the Population Council to discuss the most effective way of tackling the issue of unsafe surgical abortions in the developing world "by the safe and effective introduction of early medical [i.e., chemical] abortion."(153)

Several of the conference delegates, including the representative of the Population Council, complained that the complex protocol associated with RU486 (multiple visits, ultrasound to date the pregnancies, the need for surgical backup,etc.) inhibited the drug's introduction to developing nations.

Roy Karnovsky, president of Advances/The Neogen Group, the company set up by the Population Council to handle U.S. marketing for RU486, identified developing countries as those "with the most urgent need for this technology" and specifically asked whether the "unmet need for abortion and the morbidity and mortality from unsafe abortion in developing countries merit relaxation of the stringent requirements for quality in place in developed countries."(154)

At the time, Exelgyn rejected the idea of a double standard for developed and developing countries, maintaining that medical and surgical care and backup should be available and that there should be strict distribution controls.(155)

The legality or illegality of abortion in these countries was not an issue for conference attendees, who declared that "Advocacy for abortion is essential irrespective of the prevailing legal position regarding provision of abortion services."(156)

Considering the bleeding and other risks associated with the pill, isn't this a dangerous idea?

Certainly. With the RU486/PG chemical method, it is essential that a woman have ready access to emergency medical care should serious complications develop.(157) Owing to the dearth of medical equipment or trained medical personnel in many of these developing countries, as well as transportation and infrastructure challenges,(158) disaster probably awaits any concentrated effort to bring this to the third world.

Why an abortion pill?

Why does the pro-abortion crowd want the abortion pill?

Abortion has become increasingly unpopular with doctors, women, and the American public.

Ostracized by the medical community and worn out by thousands of abortions, many doctors are dropping abortion from their practice and fewer doctors are taking their places.(159) Women use words like "intimidating,"(160)"invasive," "mechanical," "impersonal," "abrupt,"(161) and "traumatic,"(162) to describe their abortion experiences. Increasing majorities, while perhaps not yet ready to proscribe all abortions, nevertheless see abortion as murder or at least the taking of human life, and something that should be limited.(163)

Chemical abortions, like RU486/PG, give supporters of abortion a chance to change the image of abortion, making it seem as simple as taking a pill(164) and concentrating on smaller, less developed babies whose destruction seems an easier political sell.(165) That the reality is far different -- that these abortions offer a whole new set of significant risks, that the objective is still the destruction of a unique human life -- is of little consequence to abortion's promoters as long as their false perception holds.
NOTES: 1-165[略]










●ニュース・トピックス



Long-awaited abortion pill will offer more privacy-but no less controversy

US News: News You Can Use 2/28/00
By Stacey Schultz

Four years ago, Rory Hoag was a 22-year-old on a study-abroad program in Paris when she unexpectedly found that she was pregnant. She made the painful decision to end the pregnancy?and then faced a further anxiety. "The idea of having an invasive surgical procedure in the context of a medical system I didn't understand and with doctors I didn't know really scared me," she recalls. "And I didn't want the other students to know what I was going through." In France, though, there was an alternative: abortion by medication instead of surgery.

A gynecologist prescribed a drug called mifepristone, commonly known as RU-486. Two days after taking it, Hoag went to the hospital, where she was given another drug, misoprostol, to induce uterine contractions. After four hours of nausea and intense cramping, she went home. Hoag, who now runs a Planned Parenthood clinic in Gainesville, Fla., says she was relieved not to have to go in for surgery. "I was able to go to the doctor and keep the matter private."

フランス発売以来11年間で13か国で承認。
Mifepristone has been available in France for 11 years and has gained regulatory approval in 13 other countries, but the passionate politics of abortion in the United States has kept it off the market here. That may be about to change: Final talks are underway between the Food and Drug Administration and the Danco Group, the company sponsoring mifepristone in the United States, to clear appro-val for the American market. Called Mifeprex, the drug could be available sometime this year.

No easy solution. For women who have made the decision to end a pregnancy, medical abortion can offer the comfort of being at home for much of the process. Women who have taken part in clinical trials of mifepristone in the United States say they appreciate the privacy. "I wanted to share this just with my partner," says one 36-year-old woman from Washington State who requested anonymity. And activists on both sides of the abortion debate agree that the pill may ultimately broaden access to abortion for American women. One Kaiser Family Foundation survey of over 750 physicians and nurses, most of whom are not abortion providers, found that over half said they were likely to incorporate mifepristone into their practice. "Lots of doctors are not surgical types," says Diana Dell, assistant professor of obstetrics/gynecology and psychiatry at Duke University Medical Center. "They are going to be more comfortable offering an early-stage, medical procedure."

Mifepristone won't make abortion as simple as popping a pill, however. A medical abortion resembles a miscarriage. The Washington woman took the misoprostol at home and spent the next few hours experiencing intense cramping and bleeding. "I didn't expect it would last so long," she says. The logistics aren't easy, either, involving at least three visits to the doctor as well as a few hours of bed rest. The method will be subject to the same legal restrictions as surgical abortion, and those who believe abortion is wrong think it is no less wrong when the means is medical rather than surgical.

For women who decide to seek an abortion, mifepristone has some clear advantages. Surgical abortions, in which the uterus is emptied by suction or other means, often cannot be done until several weeks after a woman learns she is pregnant. Mifepristone, by contrast, is more effective the earlier in pregnancy it is used.

The drug works by blocking the action of the naturally occurring hormone progesterone, which is crucial in the earliest stages of pregnancy, helping to build the lining of the uterus to support the fertilized egg. When it is blocked, the lining breaks down, and bleeding often begins. Misoprostol, which is an approved ulcer medicine, is given two days after the mifepristone. Misoprostol causes the uterus to contract and expel the fertilized egg. In women who have been pregnant for 49 days or less, the regimen works 92 percent of the time. When it fails or causes excessive bleeding, doctors perform a surgical abortion.

Learning curve. An estimated 500,000 women in Europe have taken mifepristone, as have thousands more in clinical trials in the United States. Its safety record is generally good, doctors say, although it should not be used in people taking corticosteroids, often given for asthma, or blood-thinning drugs.

Doctors say that patients should be counseled and monitored carefully, because the cramps and bleeding can be alarming. "If you do the counseling right, the phone doesn't ring," says Richard Hausknecht, associate clinical professor of obstetrics and gynecology at Mount Sinai School of Medicine, who has provided over 3,000 medical abortions during clinical trials of mifepristone and in an off-label use of a cancer drug called methotrexate. "But if you don't do the counseling right, you will not sleep."

Doctors need to learn how much bleeding and pain is acceptable, so that they don't intervene too early with a surgical abortion. "There is no question the learning curve is steep with this drug," says Hausknecht. As a result, says Caroline Westoff, medical director of family planning at Columbia University, doctors who do not perform abortions now may be slow to offer mifepristone. "This is not going to be like a new diet drug," she says.

Nor will medical abortion be any less expensive than an early-term surgical procedure, which typically runs between $350 and $500. Between a third and half of workers with health insurance are covered for abortion, according to a recent survey conducted by the Kaiser Family Foundation, and their plans are expected to cover mifepristone, too. Under federal law, Medicaid covers abortion only when the pregnancy results from rape or incest or endangers the life of the mother, although some states have expanded Medicaid coverage.

Other barriers facing women who seek an abortion will not disappear with the approval of the drug. Troy Newman, director of Operation Rescue West, an anti-abortion group in Los Angeles, says the organization plans to picket places where the drug is available. "We will treat medical abortion no differently than any other method," he says. "We will be picketing and protesting at any abortion clinic or provider, even if it is a pharmacy." And state laws mandating waiting periods or parental notification or consent for abortion will apply to the new drug as well. "This is not going to be a cosmic revolution," says Michael Burnhill, vice president of medical affairs for Planned Parenthood. "What it is, is an advance."
--------------------------------------------------------------------------------
WHERE TO LEARN MORE
Getting it. The National Abortion Federation hotline, 800-772-9100, will provide referrals to physicians and clinics offering mifepristone once approved.

Medical details. The Population Council Web site describes mifepristone safety, use, and trials. Follow links through "Reproductive Health and Family Planning."

The morning after. The hotline at 888-NOT-2-LATE gives referrals to local health care providers willing to prescribe emergency contraception.










●リンク&リソース


MEDLINEplus: Reproductive Health (General)

Contents of this page:
General/Overviews
Clinical Trials
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Pictures/Diagrams
Research
Specific Conditions/Aspects
Dictionaries/Glossaries
Directories
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Search MEDLINE for recent research articles on
Reproductive Health (General):
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You may also be interested in these MEDLINEplus related pages:
・ InfertilityPregnancyPrenatal CarePregnancy and ReproductionGeneral/Overviews
Keeping the Reproductive System Healthy (American Medical Women's Association)

●Clinical Trials
ClinicalTrials.gov: Genital Diseases, Female (National Institutes of Health)
ClinicalTrials.gov: Genital Diseases, Male (National Institutes of Health)
ClinicalTrials.gov: Pregnancy Complications (National Institutes of Health)
Clinical Trials: Reproductive Health (CenterWatch, Inc.) - industry-sponsored clinical trials

●Diagnosis/Symptoms
Genital Problems in Women (American Academy of Family Physicians)

●Pictures/Diagrams
Atlas of the Body: Female Reproductive Organs (American Medical Association)
Atlas of the Body: Female Reproductive System (American Medical Association)
Atlas of the Body: Male Reproductive System (American Medical Association)

●Research
Workplace VDT Use Not A Risk Factor For Reduced Birth Weight, Premature Birth (National Institute for Occupational Safety and Health)

●Specific Conditions/Aspects
Frequently Asked Questions About Infertility (American Society for Reproductive Medicine)
Pelvic Inflammatory Disease (PID) (American Academy of Family Physicians)
X-Ray Radiation (Center for the Evaluation of Risks to Human Reproduction)

●Dictionaries/Glossaries
Sexual Health Glossary (American Social Health Association)

●Directories
Find a Reproductive Endocrinologist (Society for Reproductive Endocrinology and Infertility)

●Law and Policy
Reproductive Rights and Reproductive Health (Dept. of State, Bureau of Population, Refugees and Migration)

●News-Focused
FDA Approves Mifepristone for the Termination of Early Pregnancy (Food and Drug Administration)

●Organizations
American Medical Women's Association
American Society for Reproductive Medicine
Center for the Evaluation of Risks to Human Reproduction (CERHR) (Center for the Evaluation of Risks to Human Reproduction)
Centers for Disease Control and Prevention
National Women's Health Information Center (Dept. of Health and Human Services)

●Statistics
FASTATS: Reproductive Health (National Center for Health Statistics)
Reproductive Health (Centers for Disease Control and Prevention, Office of Women's Health)
Reproductive Health in Teens (Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion)

●Children
Ambiguous Genitalia: When Gender is Unclear at Birth (Mayo Foundation for Medical Education and Research)

●Men
Effects of Workplace Hazards on Male Reproductive Health (National Institute for Occupational Safety and Health)

●Teenagers
Guide to the Reproductive System for Guys (Nemours Foundation)

●Women
Effects of Workplace Hazards on Female Reproductive Health (National Institute for Occupational Safety and Health)
Last updated: 31 October 2000










●主要サイト


Population Council | Mifeprex™ (Mifepristone) Early Option Pill

Population Council Statement on FDA Approval of Mifeprex
Mifeprex: A Chronology
Mifeprex Labeling★添付文書
Medication Guide for Patients
Patient Agreement
Danco Laboratories News Release on Mifeprex and Other Information
FDA News Release on Approval of Mifeprex
The Mifeprex toll-free hotline is 1-877-4 Early Option (1-877-432-7596)

This site updated on September 28, 2000.




The Early Option Pill

by Danco Laboratories

how_Mifeprex_worksin the_newshistoryglossarydanco_labs

●Using Mifeprex
What every woman should know
Frequently asked user questions
How to get Miferex
Patient brochure
Medication guide
Patient agreement
Useer links

●Healthcare Professionals
What every provider should know
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Providing Miferex
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●Media
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What's new
An early option for women
Mifeprex* The Early Option Pill
It's what women have wanted for years: a safe, effective and innovative way to end pregnancy - taken orally, without surgery - early on.
Danco Laboratories, a women's health pharmaceutical company, is pleased to present Mifeprex, the first Food and Drug Administration approved pill for ending early pregnancy.

Mifeprex is safe and effective. Taken orally, it is non-invasive, avoiding surgery or anesthesia in most cases. Some women feel it is a more private option. When women choose the early option pill, they will receive counseling and support throughout the process.

Available directly from a doctor's office or clinic, Mifeprex can be taken from the time a woman knows she is pregnant up to seven weeks after the beginning of her last menstrual period.

Mifeprex works by blocking a hormone necessary to sustain a pregnancy. Mifeprex is followed by misoprostol, a drug that helps end pregnancy.

Bleeding and cramping are a normal part of the process. Women may experience bleeding that is similar to or greater than a heavy period and can expect bleeding or spotting for an average of 9-16 days. In some cases, women may have severe bleeding and need to contact their doctor right away. Side effects that may occur include nausea, headache, vomiting, and diarrhea. A pain reliever can be taken to alleviate discomfort.
Mifeprex, the wait is over.
The Mifeprex hotline can be called toll free at 1-877-4 Early Option (1-877-432-7596).
* Mifeprex is a trademark of Danco Laboratories, LLC













[1411]●製品 ミソプロストールMisoprostol (Cytotec [Pfizer])サイトテック錠


 日本語版註)ミソプロストールMisoprostol (Cytotec [Pfizer])サイトテック錠
 【別名】 【開発元】Pfizer  [DBR_ID]13041-232P
 【化学名】methyl(±)- (1R*, 2R*, 3R*)-3-hydroxy-2-[(E)-4-hydroxy-4-methyl-1-octenyl]-5-oxocyclopentaneheptanoate
 【承認】FDA承認=Dec 27, 1988[0.2mg]Sep 21, 1990[0.1mg]、米国発売Feb-1989[Pfizer社G.D.Searle事業部が販売] ;
 【製剤】Cytotec oral tablets contain either 100 mcg or 200 mcg of misoprostol
 【適応】Cytotec (misoprostol) is indicated for reducing the risk of NSAID (nonsteroidal antiinflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer.
Cytotec has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Cytotec should be taken for the duration of NSAID therapy. Cytotec has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months’ duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.
 【用法用量】通常、成人にはミソプロストールとして1回200μgを1日4回(毎食後)経口投与する。
 【作用】
 【特徴】1.非ステロイド性消炎鎮痛剤の長期投与に伴う胃及び十二指腸潰瘍に対する適応が承認された初めての薬剤である。
2.臨床用量において,基礎,刺激及び夜間酸分泌の抑制作用とともに,胃粘膜血液量の増加,重炭酸イオン分泌の増加等の作用を示す。すなわち,攻撃因子の抑制作用と防御因子の増強作用とを併せ持つ。
3.シメチジン(H2受容体拮抗剤)及びスクラルファート(胃粘膜保護剤)が効果を示さない胃粘膜傷害惹起物質(無水エタノール,胆汁酸,塩酸等)による胃粘膜傷害に対して抑制効果を示す。
4.非ステロイド性消炎鎮痛剤の継続投与下で,胃潰瘍に対する内視鏡判定治癒率は65.7%(44/67例),有用率は76.4%(55/72例)であり,十二指腸潰瘍に対する内視鏡判定治癒率は83.3%(5/6例),有用率は66.7%(4/6例)であった。
5.H2受容体拮抗剤治療抵抗性の胃潰瘍に対し,非ステロイド性消炎鎮痛剤継続投与下において,治癒効果を示す(治癒率52.9%)。
6.副作用は調査症例数4,692例中545例(11.6%),766件に発現し,その主なものは,下痢・軟便227件(4.8%),腹痛92件(2.0%),腹部膨満感57件(1.2%),嘔気52件(1.1%)等であった。また,重大な副作用としてショック,アナフィラキシー様症状(頻度不明)が報告されている。 
 【臨床成績】 
 【副作用】 
 【製品情報】CYTOTEC 【添付文書】CYTOTEC U.S. Physician Prescribing Information
 【提携】 【EU】2013年2月現在、約80ヵ国で承認・発売されている。 CYTOTEC:瑞1985年9月発売、豪1986年4月発売、仏1987年8月発売、英1988年9月発売、米1989年2月発売、伊1989年12月発売 
 【日本】サイトテック錠100,200[発売/科研製薬株式会社 製造販売/ファイザー株式会社]Cytotec 承認1993年1月19日[200]1996年6月21日[100] 薬価収載1993年3月19日[200]1996年12月13日[100] 発売1993年3月25日[200]1996年12月13日[100] 国際誕生年月1984年6月 【製剤~日本】1錠中ミソプロストール 100μg ,200μg  【適応~日本】非ステロイド性消炎鎮痛剤の長期投与時にみられる胃潰瘍及び十二指腸潰瘍  【用法用量~日本】通常、成人にはミソプロストールとして1回200μgを1日4回(毎食後及び就寝前)経口投与する。なお、年齢、症状により適宜増減する。 【製品情報~日本】サイトテック錠 【添付文書~日本】サイトテック錠 - インタビューフォーム 【その他】
 【開発の経緯】
ミソプロストールは1973年米国G.D.サール社(現,米国ファイザー社)により“胃酸分泌抑制作用が強く,経口投与で活性を有し,作用時間が長い”ことを目標として合成されたプロスタグランジンE1誘導体である。ミソプロストールはそのままでは化学的に不安定なため,ヒドロキシプロピルメチルセルロースに分散させた“ミソプロストール分散体”を原体として,室温で長期間安定なサイトテック錠200を製することに成功した。本剤は,胃酸分泌抑制作用のみならず,強酸,強塩基及び無水エタノール等の壊死惹起物質による上部消化管傷害の防御,胃粘膜血液量の増加,重炭酸イオンの分泌増加及び粘液分泌の増加等の粘膜保護作用(サイトプロテクション作用)を併せもち,1981年より国内臨床試験が開始された。その結果,非ステロイド性消炎鎮痛剤(NSAID)投与時にみられる胃及び十二指腸潰瘍患者に対して優れた治療効果を示すことが認められ,1993年に承認を得て発売に至った。また,本剤は高齢者を適応疾患の対象とする場合が多く,個々の症例に合わせてより一層用量調節をしやすくするために,従来の半分量を含有するサイトテック錠100が開発され,1996年に承認を得た。
また,3,646例の使用成績調査を実施し,1999年4月に再審査申請を行った結果,2002年9月に薬事法第14条第2項各号(承認拒否事由)のいずれにも該当しないとの再審査結果を得た。
2003年10月現在,世界約90ヵ国で承認・発売されている。
US Pharmacopeial Commission
AMA: United States Adopted Names
BIAM
 --- BIAM -ABC順|BIAM -会社順
NLM: MeSH HOme
 ---MeSH Online search


13041-232P MISOPROSTOL[USAN] ミソプロストール by SEARLE G.D.& COMPANY[US]
ARTHROTEC TABS[W/DICLOFENAC];CYTOTEC;CYTOTEC TAB サイトテック;Cytotec Tabs 100;Misodex;MISOPROSTOL[USAN];NAPRATEC TABS[W/NAPROXEN];SC-29333;サイトテック;ミソプロストール
《JA》CYTOTEC TAB サイトテック(サール薬品㈱)03-93*∥Cytotec Tabs 100(日本モンサント㈱)12-96*承認960621:サイトテック錠100●発売元:科研製薬㈱∥《US》CYTOTEC(SEARLE G.D.& COMPANY)03-89*∥《UK》CYTOTEC(SEARLE G.D.& COMPANY)10-88*∥NAPRATEC TABS[W/NAPROXEN](SEARLE G.D.& COMPANY)10-91*∥ARTHROTEC TABS[W/DICLOFENAC](SEARLE G.D.& COMPANY)02-92*∥《FR》CYTOTEC(SEARLE G.D.& COMPANY)12-87*∥《WG》CYTOTEC(SEARLE G.D.& COMPANY)05-86*∥《IT》CYTOTEC(SCHIAPPARELLI SEARLE) -89*∥Misodex(MENARINI)11-95*



【日本語版コメント1411~自然流産薬ミソプロストール/2013.03.04】
Misoprostol(抗潰瘍薬)とmifepristone(日本未開発)は、WHO Essential medicinesとして指定され、unsafe abortion(安全でない流産)を防ぐためにWHOから推奨されている。
 →詳細は参考資料●MLリソース:中絶ピルに纏めた。



●承認データ:FDA

FDA Newsroom - FDA Press Releases Index to Drug-Specific InformationCytotec (misoprostol) ●2004.5.1 以降 Drugs@FDA

★Drug Name(s) =CYTOTEC (MISOPROSTOL) FDA Application No. =(NDA) 019268 Active Ingredient(s)=MISOPROSTOL Company =GD SEARLE LLC Dosage Form/Route =TABLET; ORAL Strength =0.1MG ,0.2mg - Approval Date=12/27/1988[000][Approval]:|Review|   申請  適応 Original Approval or Tentative Approval Date December 27, 1988 Chemical Type 1 New molecular entity (NME) Review Classification P Priority review drug
Electronic Orange Book

Application Number: N019268 Active Ingredient : MISOPROSTOL Proprietary Name : CYTOTEC [GD SEARLE LLC] TABLET; ORAL 0.1MG,0.2MG Approval Date : Dec 27, 1988[0.2mg]Sep 21, 1990[0.1mg] Exclusivity Data : x Patent Data : x /2013.07.04/
Appl NoTE Code RLDActive
Ingredient
Dosage Form;
Route
StrengthProprietary
Name
Applicant承認日特許先発権
N020607ABNoDICLOFENAC SODIUM;MISOPROSTOLTABLET, DELAYED RELEASE; ORAL50MG;0.2MG/75MG;0.2MGARTHROTECGD SEARLE LLCDec 24, 19972014x
A200158ABNoDICLOFENAC SODIUM;MISOPROSTOLTABLET, DELAYED RELEASE; ORAL50MG;0.2MG//75MG;0.2MGDICLOFENAC SODIUM AND MISOPROSTOLSANDOZMay 9, 2013xx
A201089ABNoDICLOFENAC SODIUM;MISOPROSTOLTABLET, DELAYED RELEASE; ORAL50MG;0.2MG/75MG;0.2MGDICLOFENAC SODIUM AND MISOPROSTOLWATSON LABS INCJul 9, 2012xx
N019268ABNoMISOPROSTOLTABLET; ORAL0.1MG;;0.2MGCYTOTECGD SEARLE LLCDec 27, 1988[0.2mg]Sep 21, 1990[0.1mg]xx
A076095ABNoMISOPROSTOLTABLET; ORAL0.1MG;0.2MGMISOPROSTOLIVAX SUB TEVA PHARMSJul 10, 2002xx
A091667ABNoMISOPROSTOLTABLET; ORAL0.1MG;;0.2MGMISOPROSTOLNOVEL LABS INCJul 25, 2012xx
●関連記事

[WHO]18th Expert Committee on the Selection and Use of Essential Medicines[Geneva 2010;27P] - PROPOSAL FOR THE INCLUSION OF MISOPROSTOL IN THE WHO MODEL LIST OF ESSENTIAL MEDICINES ●[WHO]Expanding access to medical abortion: Perspectives of women and providers in developing countries Clinical trials of mifepristone alone for early abortion began in 1982 and reported complete abortion rates of less than 80%. It was soon discovered that the rates could be improved to nearly 100% if a prostaglandin analogue was administered 24–48 hours after mifepristone... ●[WHO]Preventing unsafe abortion - mifepristone /misoprostol ●[WHO]Fertility regulationMisoprostol to prevent and treat postpartum haemorrhage: a systematic review
and meta-analysis of maternal deaths and dose-related effects
Bulletin of the World Health Organization 2009;87:666-677 ●Comparative effectiveness, safety and acceptability of
medical abortion at home and in a clinic: a systematic review
Bulletin of the World Health Organization 2011;89:360-370. ●[WHO Statement]Clarifying WHO position on misoprostol use in the community to reduce maternal death[2010] ●WHO | Essential Medicines

[2007. 8. 29 日経メディカル]
日本では経口妊娠中絶薬は承認されていないが、デンマークなどでは薬物的中絶が広く行われている。この薬物的中絶について、次の妊娠に対する影響はあるのだろうか。デンマークで行われた国家規模のコホート研究で、薬物的中絶後の妊娠に見られる異常の頻度は、外科的中絶と同等であることが示された。米国California大学Los Angeles校のJasveer Virk氏らの報告で、詳細はNEJM誌2007年8月16日号に掲載された。

ミソプロストールがWHOの不全流産治療の不可欠な薬品に[情報ライブラリ/ブログ「つばさ」2009年05月01日]
ミソプロストールがWHO(世界保健機関)の、不全流産と流産の治療のための不可欠な薬品のモデルリストに追加される。

 世界保健機関は、不全流産(流産が生じたが、子宮内に残存物が残っている状態)の治療のために安全性とその効果が証明された不可欠な薬剤のリストにミソプロストールが含まれることになったと発表しました。その判断は有効な証拠を評価した専門委員会によってなされました。その証拠は、不全流産などの流産のためのいくつかのガイドラインと大規模無作為化または比較臨床試験を含みます。

 提案は、以下の証拠と考察に基づきGynuity Health Projectsによって提出されました。








[1091,1392,1493]●製品 mifepristone (Mifeprex Tablet[Population Council])
クッシング症候群の治療薬ミフェプリストンmifepristone (Korlym [Corcept Therapeutics ])


 日本語版註)mifepristone (Mifeprex Tablet[Population Council])
 【別名】MIFEGYNE;MIFEPRISTONE[INN];RU 38486;RU 486 【開発元】Aventis[前身のRoussel] [DBR_ID]12910
 【化学名】11β-[4-(N,N-dimethylaminyl)]-benzyl-17β-hydroxy-17α-(1-propynenyl)-estra-4,9-diene-3-one ; 11β-[p-(Dimethylamino)phenyl]-17β-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one
 【承認】FDA申請=、FDA承認=18-Sep-96内定→Feb-2000内定→28-Sep-2000[The Population Council]、販売Danco Laboratories;
 【製剤】錠剤-200mg mifepristone  【適応】(70日間迄の子宮内妊娠の中止) MIFEPREX is a progestin antagonist indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation(初承認時Mifeprex is indicated for the medical termination of intrauterine pregnancy through 49 days' pregnancy) 【用法用量】第1日目200mg MIFEPREX、次いでMIFEPREX服用24-48時間後に800 mcg buccal misoprostol
 【作用】 【特徴】 
 【製品情報】■Mifepristone Information 【添付文書】http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020687s020lbl.pdf
 【EU】2000年EU)11か国で解禁 【日本】未開発 【その他】《UK》MIFEGYNE(ROUSSEL UCLAF SA)08-91*∥《FR》MIFEGYNE(ROUSSEL UCLAF SA)-90*


 日本語版註)mifepristone (Korlym [Corcept Therapeutics ])
 【別名】 【開発元】Corcept Therapeutics Inc[米国]  [DBR_ID]
 【化学名】11ß-(4-dimethylaminophenyl)-17ß-hydroxy-17α-(1-propynyl)-estra-4,9-dien-3-one
 【承認】FDA申請=15-Apr-2011、FDA承認=17-Feb-2012、米国発売10-Apr-2012 ;
 【製剤】1錠中mifepristone 300mg 【適応】indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. 【用法用量】初回1日1回300mg。 最大1200mg
 【作用】Mifepristone is a selective antagonist of the progesterone receptor at low doses and blocks the glucocorticoid receptor (GR-II) at higher doses. Mifepristone has high affinity for the GR-II receptor but little affinity for the GR-I (MR, mineralocorticoid) receptor. In addition, mifepristone appears to have little or no affinity for estrogen, muscarinic, histaminic, or monoamine receptors. 【特徴】a cortisol receptor blocker 
 【臨床成績】 
 【副作用】 
 【製品情報】www.korlym.com 【添付文書】Korlym -PI
 【提携】 【EU】 
 【日本】未開発 【その他】



【日本語版コメント1493~ミフェプリストン(Mifeprex)のラベル変更/2016.04.25】
 2016年3月29日FDAはmifepristoneによる中絶を従来の49日以内の妊娠期間から70日以内への延長を承認した。
 →詳細は参考資料●MLリソース:中絶ピルに纏めた。
 FDAは、子宮内妊娠中絶薬として米国で15年以上前から使用されている経口抗黄体ホルモン製剤のミフェプリストンMifepristone(Mifeprex - Danco;日本未開発)について、いくつかの重要なラベリングの変更を承認した1。 本剤は一般にプロスタグランジンアナログのミソプロストール(Cytotec、ジェネリック;サイトテック錠[科研製薬])と併用される。
結論 - FDAのミフェプリストン(Mifeprex)のラベリング変更により、ミフェプリストンの低用量投与、妊娠初期の後期での投与、ミソプロストール(Cytotec、ジェネリック)の高用量かつより有効な経頬粘膜での自己投与が可能となり、受診回数が減少する。
1. Mifepristone (RU 486). Med Lett Drugs Ther 2000; 42:101.





【日本語版コメント1392~クッシング症候群の治療薬ミフェプリストン(Korlym -Corcept Therapeutics)/2012.6.11】
 クッシング症候群は,血中のコルチゾルまたは関連するコルチコステロイドの慢性高値によって引き起こされた一群の臨床異常である。クッシング病は下垂体のACTH過剰産生に起因するクッシング症候群で,通常は下垂体腺腫に続発する。 日本では平均して年に約100症例が新規クッシング症例として診断され、そのうち約50%が副腎性、40%程度がクッシング病と考えられている。 最近公費対象の特定疾患に指定され、交付件数は、間脳下垂体機能障害(PRL分泌異常症、ゴナドトロピン分泌異常症、ADH分泌異常症、 下垂体性TSH分泌異常症、クッシング病、先端巨大症、下垂体機能低下症)として平成22年度11,764件。
 日本ではミトタン(オペプリム[ヤクルト本社)、トリロスタン(デソパン錠60mg[持田製薬])、メチラポン(メトピロンカプセル250mg[ノバルティスファーマ])の3製品がクッシング症候群の適応を承認されている。
 →詳細は参考資料●MLリソース:中絶ピルMLリソース:クッシング症候群に纏めた。
1392★28/12★12.06.11★046★クッシング症候群の治療薬ミフェプリストン(Korlym -Corcept Therapeutics)/2pMLリソース:中絶ピルMLリソース:クッシング症候群


●承認データ:FDA

FDA Newsroom - FDA Press Releases FDA approves Korlym for patients with endogenous Cushing’s syndrome[Feb. 17, 2012] Index to Drug-Specific Information Mifeprex (mifepristone) Information Mifepristone: Approval Process and Postmarketing Activities[07/22/2009] Draft Guidance on Mifepristone ●2004.5.1 以降 Drugs@FDA

★Drug Name(s) =MIFEPREX (MIFEPRISTONE) FDA Application No. =(NDA) 020687 Active Ingredient(s)=MIFEPRISTONE Company =DANCO LABS LLC (承認時Population Council) Dosage Form/Route =TABLET; ORAL Strength =200MG - Approval Date=09/28/2000[000][Approval]:Label[添付文書]|Letter[承認書]|Review|   申請14-Mar-1996  適応 For the medical termination of intrauterine pregnancy through 49 days' pregnancy Original Approval or Tentative Approval Date September 28, 2000 Chemical Type 1 New molecular entity (NME) Review Classification P Priority review drug - Approval Date=03/29/2016[020][New Dosage Regimen]:Label[添付文書]|Letter[承認書]|REMS| To Danco Laboratories,LLC   申請28-May-2015  適応This "Prior Appraval" supplemental new drug application proposes to provide for use through 70 days gestation, revise the labeled dose and dosing regimen and modify the REMS. ★Drug Name(s) =KORLYM (MIFEPRISTONE) FDA Application No. =(NDA) 202107 Active Ingredient(s)=MIFEPRISTONE Company =Corcept Therapeutics Dosage Form/Route =TABLET; ORAL Strength =300MG - Approval Date=02/17/2012[000][Approval]:Label[添付文書]|Letter[承認書]|Review|Summary Review   申請April 15, 2011  適応This new drug application provides for the use of Korlym (mifepristone) for the control of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. Original Approval or Tentative Approval Date February 17, 2012 Chemical Type 5 New manufacturer Review Classification S Standard review drug

情報ソース●CDER New and Generic Drug Approvals: 1998-2003 Mifeprex (mifepristone) Tablet, Rx
Population Council Application #=NDA 20-687 Approval Date=9/28/00 Letter Posted=9/28/00 Label Posted =9/28/00※添付文書 Review Posted=9/28/00
Electronic Orange Book

Application Number: 020687 Active Ingredient : MIFEPRISTONE Proprietary Name : MIFEPREX [DANCO LABS LLC] Tablet; Oral 200MG Approval Date : SEP 28, 2000 Exclusivity Data : NCE SEP 28,2005 Patent Data : #4626531 OCT 12,2004 Application Number: N202107 Active Ingredient : MIFEPRISTONE Proprietary Name : KORLYM [CORCEPT THERAP] TABLET; ORAL 300MG Approval Date : Feb 17, 2012 Exclusivity Data : NP Feb 17, 2015 Patent Data : x




Mifepristone Information

The Food and Drug Administration has approved mifepristone (trade name Mifeprex)
 for the termination of early pregnancy, defined as 49 days or less, counting
  from the beginning of the last menstrual period.
・Dear Healthcare Professional LetterQuestions and Answers about MifepristonePress Release on Mifepristone Approval (9/28/2000)
・Mifepristone Approval Letter 9/28/00.   Optional Format: PDF.  (9/28/2000) 承認書
・Mifepristone Label.  Optional Format: PDF (9/28/2000) 添付文書
・Mifepristone Medication Guide. (9/28/2000) 患者向け簡単ガイド
・Questions and Answers about Mifepristone  (9/28/2000)
・Patient Agreement Form[pdf] (9/28/2000)
・Prescriber's Agreement Form[pdf] (9/28/2000)
・Mifepristone Review (9/28/2000)
・Office Memo to Population Council [pdf] (9/28/2000)
・Federal Register Final Rule, Restrictions on Use After Marketing (12/2/1992)
・Mifepristone (Mifeprex) Index of Redacted Documents   (1/30/2002)
 Last Updated: December 16, 2002



FDA Approves Mifepristone for Termination of Early Pregnancy

U.S. Food and Drug Administration> FDA Consumer magazine
November-December 2000> Table of Contents

FDA Approves Mifepristone for Termination of Early Pregnancy
THE FOOD AND DRUG ADMINISTRATION approved mifepristone (trade name Mifeprex, previously known as RU-486) on September 28 for the termination of early pregnancy. Mifepristone blocks the hormone progesterone, which prepares the lining of the uterus for a fertilized egg and helps maintain pregnancy. Early pregnancy is defined as 49 days or less, counting from the beginning of the last menstrual period.

Mifepristone is part of an approved treatment regimen that calls for at least three visits to a doctor's office or clinic. On the first visit, the woman receives counseling and a medication guide. She then takes 600 milligrams of mifepristone (three 200 milligram pills) by mouth while in the doctor's office. Two days later, she returns to the physician and, if she is still pregnant, takes 400 micrograms (two 200-microgram pills) of misoprostol--again while in the doctor's office. Misoprostol, a prostaglandin previously approved by FDA for the treatment of ulcers, causes the uterine muscles to contract and end the pregnancy.

Approximately 14 days after the first visit, the woman returns to her doctor to determine whether the pregnancy has been terminated. The combination of mifepristone and misoprostol has been shown in studies to end pregnancy in about 92 to 95 percent of women. In the few cases where the pregnancy is not terminated by the drug treatment, the doctor then discusses options with the patient, including surgery to end the pregnancy. There is a chance that there may be birth defects if the pregnancy results in a live birth after treatment with mifepristone and misoprostol.

The medication guide given to each woman who is prescribed mifepristone fully explains how to take the drug, who should avoid taking it, and what side effects can occur. Both the doctor and patient must sign a Patient Agreement Form stating that the patient understands the benefits and risks of the treatment and has decided to end her pregnancy.

"The approval of mifepristone is the result of the FDA's careful evaluation of the scientific evidence related to the safe and effective use of this drug," said FDA Commissioner Jane E. Henney, M.D. "The FDA's review and approval of this drug has adhered strictly to our legal mandate and mission as a science-based public health regulatory agency."

FDA based its approval on data from clinical trials in the United States and France.

The drug's label emphasizes that most women using mifepristone will experience some side effects, mostly cramping and vaginal bleeding. Bleeding and spotting will typically last between 9 and 16 days. In about one out of 100 women, bleeding can be so heavy that surgery will be required to stop it. The drug's labeling also warns that mifepristone should not be used in women with certain conditions, including ectopic ("tubal") pregnancy. An ectopic pregnancy occurs when a fertilized egg begins to grow in one of the fallopian tubes that connect the ovaries to the uterus.

Mifepristone, not available in pharmacies, is distributed only to physicians who can accurately determine the duration of a patient's pregnancy and detect an ectopic pregnancy. Physicians who prescribe the drug must also be able to perform surgery in cases of an incomplete abortion or severe bleeding--or they must have made plans in advance to provide this care through other qualified physicians.

 フランスで1988で承認されたのが最初で、以来62万人が利用してきた。
Mifepristone was developed by a French pharmaceutical firm and was first approved for use in France in 1988. Since then, more than 620,000 European women have taken mifepristone, known in Europe as RU 486, in combination with a prostaglandin (such as misoprostol) to terminate pregnancy. Mifepristone has also been approved in the United Kingdom, Sweden, and other countries.

Mifepristone's sponsor is a New York-based nonprofit group, the Population Council. The drug will be distributed in the United States by Danco Laboratories, LLC, New York.

More detailed information about mifepristone is available on FDA's Web site at www.fda.gov/cder/drug/infopage/mifepristone/.
(Hypertext created by clb 2000-OCT-17)


FDA APPROVES MIFEPRISTONE FOR THE TERMINATION OF EARLY PREGNANCY

HHS NEWS
September 28, 2000
FOR IMMEDIATE RELEASE

The Food and Drug Administration today approved mifepristone (trade name Mifeprex) for the termination of early pregnancy, defined as 49 days or less, counting from the beginning of the last menstrual period.

Under the approved treatment regimen, a woman first takes 600 milligrams of mifepristone (three 200 milligram pills) by mouth. Two days later, she takes 400 micrograms (two 200-microgram pills) of misoprostol, a prostaglandin. Women will return for a follow-up visit approximately 14 days after taking mifepristone to determine whether the pregnancy has been terminated.

Because of the importance of adhering to this treatment regimen, each woman receiving mifepristone will be given a Medication Guide that clearly explains how to take the drug, who should avoid taking it, and what side effects can occur.

"The approval of mifepristone is the result of the FDA's careful evaluation of the scientific evidence related to the safe and effective use of this drug," said Jane E. Henney, M.D., Commissioner of Food and Drugs. "The FDA's review and approval of this drug has adhered strictly to our legal mandate and mission as a science-based public health regulatory agency."

FDA based its approval of mifepristone on data from clinical trials in the United States and France.

The labeling for mifepristone emphasizes that most women using the product will experience some side effects, primarily cramping and bleeding. Bleeding and spotting typically last for between 9 and 16 days. In about one of 100 women, bleeding can be so heavy that a surgical procedure will be required to stop the bleeding.

The drug's labeling also warns that it should not be used in women with the following conditions:

Confirmed or suspected ectopic ("tubal") pregnancies
Intrauterine device (IUD) in place
Chronic failure of the adrenal glands
Current long-term therapy with corticosteroids
History of allergy to mifepristone, misoprostol or other prostaglandins
Bleeding disorders or current anticoagulant (blood-thinning) therapy.
Under the terms of the approval, mifepristone will be distributed to physicians who can accurately determine the duration of a patient's pregnancy and detect an ectopic (or tubal) pregnancy. Physicians who prescribe mifepristone must also be able to provide surgical intervention in cases of incomplete abortion or severe bleeding--or they must have made plans in advance to provide such care through others.

To gather additional data about the use of mifepristone, the Population Council (sponsor of the product) has made a commitment to conduct postmarketing studies. These include a study comparing patient outcomes among physicians who refer their patients needing surgical intervention, compared to those who perform surgical procedures themselves; an audit of prescribers that will examine whether patients and their physicians are signing the patient agreement and placing it in the patient's medical record, as required; and a system for surveillance, reporting and tracking rare ongoing pregnancies after treatment with mifepristone in the U.S.

Mifepristone, which was developed by a French pharmaceutical firm, was first approved for use in France in 1988. Since then, more than 620,000 European women have taken mifepristone in combination with a prostaglandin to terminate pregnancy. The drug has also been approved in the United Kingdom, Sweden, and other countries.

Mifepristone will be distributed in the U.S. by Danco Laboratories, LLC, New York, N.Y.
More detailed information about this product is available on FDA's website at www.fda.gov/cder/drug/infopage/mifepristone/.
Office of Public Affairs
Web page created by Office of Public Affairs 2000-SEP-28.



Population Council

 -http://www.popcouncil.org/; 1952年、John D. Rockefeller 3rdにより設立。
 全世界17か国にオフィスを持ち、70か国で活動。
 The Council's Center for Biomedical Research (CBR)は、ピルや避妊具を開発、販売。
●MediaCenterPopulation Council | Mifeprex™ (Mifepristone) Early Option Pill
Mifeprex Labeling★添付文書
Danco Laboratories News Release on Mifeprex and Other Information



The Early Option Pill

 - http://www.earlyoptionpill.com/; Danco Laboratories社公式サイト
●The Early Option Pill
 - Mifeprex
in the_news
Product labelling※添付文書

●News Archives





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■2016 -------------------------------
1493★32/09★16.04.25★055★ミフェプリストン(Mifeprex)のラベル変更/2pMLリソース:中絶ピル
■2013 -------------------------------
1411★29/05★13.03.04★019★自然流産薬ミソプロストール/2pMLリソース:中絶ピル
■2012 -------------------------------
1392★28/12★12.06.11★046★クッシング症候群の治療薬ミフェプリストン(Korlym -Corcept Therapeutics)/2pMLリソース:中絶ピルMLリソース:クッシング症候群
■2000 -------------------------------
1091★16/23★00.10.30★101★ミフェプリストン(RU486)/2pMLリソース:中絶ピル
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作成:2000.11.23 最終更新:2017.02.03 小菅博之
The Medical Letter日本語版
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On Drugs and Therapeutics

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