ST LOUIS (MD Consult) - On July 13, 2009, Teva Pharmaceutical Industries, Ltd, announced that the US Food and Drug Administration (FDA) has approved Plan B One-Step (levonorgestrel tablet, 1.5 mg), an emergency contraception product. The advertised advantage of the product is that it offers protection from unintended pregnancy with only a one-time, one-pill dose. The product is intended to be used to prevent pregnancy after a woman engages in unprotected sex or experiences contraceptive failure.

 

When taken as directed, within 72 hours (3 days) of unprotected sex or contraceptive failure, Plan B One-Step has been shown to be highly effective in reducing the chance of pregnancy. Teva states that approximately 7 of 8 women who would otherwise have become pregnant will not become pregnant after taking Plan B One-Step. The manufacturer claims that the product is most effective when taken very soon after unprotected sex has occurred. Teva cautions that Plan B One-Step will not be effective if a woman is already pregnant. Furthermore, use of the drug will not terminate an existing pregnancy.

Adverse effects of Plan B One-Step include menstrual changes, nausea, fatigue, headache, dizziness, lower abdominal pain, and breast tenderness. A patient should be aware that she may be pregnant if her menstrual period is delayed longer than 1 week.

A press release by Teva states that the FDA is expanding over-the-counter (OTC) access to Plan B One-Step to consumers aged 17 years or older who present government-issued proof-of-age identification. Access to the product for persons younger than 17 years is available with a prescription.

Teva plans to have product available at licensed US retail pharmacies in August 2009.

圣路易斯(MD Consult)——2009年7月13日， 梯瓦制药有限公司(Teva Pharmaceutical Industries, Ltd)宣布，美国食品药品管理局(FDA)已批准单次B计划药(Plan B One-Step，1.5mg左炔诺孕酮片剂)——一种紧急避孕药的应用。该药优势为仅单次、单片服用即可预防意外妊娠。此药主要用于防止女性在无保护措施的性行为或其他避孕措施失败后发生妊娠。

研究表明，在无保护措施的性行为后或避孕措施失败的72h(3d)内，按照说明书服用单剂B计划药可大大降低妊娠的发生几率。梯瓦公司声称， 8名妇女中约有7名在服用单剂B计划药后避免了妊娠的发生。该生产厂家宣称，在发生无保护措施的性行为后，越早服用此药预防妊娠的效果越好。梯瓦公司亦警告称，单剂B计划药对已妊娠女性无效。此外，服用该药并不会终止已发生的妊娠。

单剂B计划药的不良反应包括月经的改变、恶心、乏力、头痛、眩晕、下腹痛以及乳房触痛等。患者应知道其月经周期若延迟1w以上则有可能怀孕。

梯瓦公司在新闻发布会上正式宣布，FDA已批准单剂B计划药可作为非处方药(OTC)，面向年龄在17岁或17岁以上、有政府出具的年龄证明的女性出售。年龄小于17岁者需持医生处方购买此药。

梯瓦公司拟于2009年8月在有经营许可证的美国零售药房出售此药。