The FDA is placing restrictions on accutane:
WASHINGTON – 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 curbs Friday in trying to keep Accutane and its generic competitors on the market while ensuring that women who use the risky pills don’t get pregnant. Critics see it as the drug’s last chance, after two decades of safety warnings and other restrictions failed to end Accutane-damaged pregnancies.
Accutane first hit the market in 1982. Since then, well over 2,000 pregnancies have occurred among users. “The vast majority ended in abortion or miscarriage, but the FDA counts more than 160 babies born with drug-caused defects.”
Under the program, every patient — men and women — must enroll in the iPLEDGE computerized registry starting Dec. 31 to receive Accutane or generic versions of the drug isotretinoin.
Doctors must register, too, if they wish to continue prescribing the pills. Drugstores and wholesalers also must register in order for the pills’ manufacturers to ship them any supplies.
The registry opens early, on Aug. 22nd, so people have plenty of time to learn how it will work. ” On that date, patients may enroll at http://www.ipledgeprogram.com or by phone at 1-866-495-0654.” For federal accutane info, click here.