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Thread: FDA clamps down on Roche acne drug

  1. #1

    FDA clamps down on Roche acne drug

    FDA clamps down on Roche acne drug
    By Christopher Bowe in New York
    Published: August 12 2005 20:45 | Last updated: August 12 2005 20:45

    US regulators on Friday tightened the distribution and prescription of Accutane to prevent the use of the acne treatment by pregnant women because it can cause birth defects.

    Accutane is one of five drugs that David Graham, a safety researcher at the Food and Drug Administration, said should be subjected to closer scrutiny.

  2. #2

    Saturday, August 13, 2005; Page A14

    FDA Orders Registry For Accutane Users

    The thousands of Americans who take the acne drug Accutane -- and people who prescribe and dispense it -- must enroll in a national registry, part of a major government program to tighten access to the medicine that causes birth defects.

    The Food and Drug Administration enacted unprecedented restrictions yesterday in trying to keep Accutane and its generic competitors on the market while also trying to ensure that women who use the pills do not get pregnant.

    "This is a system that has been long in the works, and many would say is long overdue," said Sandra Kweder, FDA deputy drug chief.

    Since Accutane hit the market in 1982, more than 2,000 pregnancies among users have been reported. The vast majority ended in abortion or miscarriage, but the FDA counts more than 160 babies born with drug-caused defects.

    A baby can suffer severe brain and heart defects, mental retardation, and other abnormalities.

  3. #3
    Dr. Young, your thoughts?

    I have seen Max post articles without specifying a reason and he got called for it, also I think Dr. JJ
    Don't ignore the Reeve Legacy, Remember he and Dana supported open research and fought hard for ESCR


    Support H.R. 810

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