Access to acne drug is curbed

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.

"This is a system that has been long in the works and many would say is long overdue," acknowledged Dr. Sandra Kweder, FDA's deputy drug chief. "The responsibility for ensuring that fetuses are not exposed to this medicine is enormous and is shared by everyone" who takes, prescribes or sells it.

If a woman becomes pregnant while taking the acne drug, her baby can suffer severe brain and heart defects, mental retardation and other abnormalities, even if the mother took only a small dose for a short period. That's a risk for 30 days after stopping the drug, too.

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.

The pharmacist must check the computer database before filling a prescription. Accutane manufacturer Hoffman-La Roche and generic manufacturers will monitor drugstores and wholesalers and are supposed to cut off violators' sales supplies.

Accutane is supposed to be used for severe acne only, but it is widely acknowledged to be prescribed for more minor cases. The FDA estimates that 100,000 prescriptions are filled each month.

The registry opens Aug. 22, giving users extra time to learn how it works before the provisions become mandatory at year's end. On that date, patients may enroll at www.ipledgeprogram.com or by phone at (866) 495-0654.