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    Accutane's Pregnancy Risk: Are Women Aware?

    Researchers Find Some Women May Not Have Heard About Birth Defects Linked to Acne Drug
    WebMD Health News
    Reviewed by Louise Chang, MD

    Oct. 14, 2005 -- Some women apparently aren't getting the message that they shouldn't take the acne drug Accutane and its generic versions during pregnancy.

    Accutane and its generic versions are an effective acne treatment, but they're not intended for use during pregnancy due to the risk of birth defects.

    That well-publicized risk is stressed in information from the drug's makers. The FDA also recently tightened its rules to try to prevent pregnant women from taking Accutane or its generic versions.

    The drug's old pregnancy prevention program was voluntary. It wasn't always heeded, a new report shows.

    The researchers included Julia Robertson of the Birth Defects and Genetics Program in Utah's health department. Their findings appear online in Birth Defects Research (Part A): Clinical and Molecular Teratology.

    Pregnant and at Risk

    The report included 34 women who had taken Accutane or its generic versions while pregnant. Between April 2002 and September 2004, the women had voluntarily called a hotline run by the Organization of Teratology Information Services.

    A teratogen is a substance that causes birth defects.

    Many of the women said they didn't remember hearing or following the old guidelines.

    For instance, the old program recommended that women get birth control counseling and two negative pregnancy tests before starting the drug.

    Eight women said they didn't remember being counseled about birth control, and 25 said they hadn't gotten a second pregnancy test before taking the drug.

    Also, the program advised monthly pregnancy tests while women took the drug. More than half said they hadn't done that. The drug is usually taken for four to six months.

    In addition, few women reported having the type of severe acne for which the drug is intended.

    It's possible that the women's reports weren't accurate. There's also no information on women for whom the old program worked since they didn't have a reason to call the birth defects hotline.

    New Rules

    The new program, announced by the FDA in August, is called "iPLEDGE."

    The iPLEDGE plan requires virtually everyone involved with prescribing, supplying, or using the drug to register and accept certain responsibilities.

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