FDAは緊急の避妊薬を認可した 

1999/7/29 ロイター

米国食品薬剤局(FDA)は避妊をしていないときの性交後に妊娠を防ぐ避妊薬を認可した。PlanBという名称でlevonorgestrelという黄体ホルモンの錠剤を2回服用する。1錠目は性交後72時間以内に服用し、その後12時間後に2錠目を服用する。これにより妊娠の危険を8%から1%に減少させるという。性交後にできるだけ早く服用すれば効果は高くなる。

FDA approves emergency contraceptive


NEW YORK, Jul 29 (Reuters Health) -- The US Food and Drug Administration (FDA) has approved the first progestin-only pill for prevention of pregnancy after a contraceptive accident or unprotected sex.
The product, called Plan B, consists of two tablets of levonorgestrel. One tablet is taken within 72 hours after sex and the second pill 12 hours after the first pill.
Women's Capital Corp., a Washington, DC-based privately held firm, will distribute Plan B in the US and Canada.
According to a statement issued by the company, the FDA label states that Plan B ``demonstrated a superior safety profile'' over the Yuzpe regimen, and produced less nausea and vomiting. Other side effects of Plan B include abdominal pain, fatigue, headache, heavier or lighter menstrual bleeding, dizziness, and breast tenderness.
Women's Capital Corp. said that Plan B reduces the risk of pregnancy from 8% to 1%, and efficacy of the product is better if it is taken as soon as possible after unprotected intercourse.
Plan B was tested by the World Health Organization in almost 3,000 women in 15 countries. The results of the study were published in the August 8, 1998 edition of The Lancet.
Dr. Edith Guilbert, a Canadian physician who participated in the WHO study, said, ``Plan B will be much easier to administer and use than the older regimens. A new and better product will also help increase awareness of emergency contraception and this should help reduce high rates of unintended pregnancy significantly in both the United States and Canada.''
Plan B will be available by prescription through Planned Parenthood clinics and other healthcare providers listed on the company's 24-hour Emergency Contraception Hotline (1-888-NOT-2-LATE) and website (www.princeton.edu/ec/).