- The Washington Times - Friday, August 12, 2005

Everyone who uses the acne treatment Accutane will have to enroll in a national registry, along with every doctor who prescribes it and every drugstore that sells it under tough new restrictions aimed at shielding pregnant women from the birth defect-causing drug.

The Food and Drug Administration says women must show they aren’t pregnant before taking Roche Holding’s Accutane or its generic versions because of links to birth defects.

U.S. regulators announced the long-anticipated program yesterday, more than a year after the agency’s scientific advisers urged the extra curbs because repeated safety warnings have failed to stop Accutane-damaged pregnancies.

Both male and female patients will have to enroll in the registry, called IPledge, by Dec. 31 or they can no longer receive Accutane.

Women of childbearing age will have some additional steps: They’re supposed to use two forms of birth control, get two negative pregnancy tests before their initial Accutane prescription and show proof of another negative pregnancy test before each monthly refill.

Women already were supposed to be taking those steps, but using the computerized registry system, doctors and pharmacists are to ensure that that happens. One way: Each month, women will be required to enter into the registry, by phone or Internet, their two contraceptives.

All patients also must sign a document informing them of Accutane’s risks, including the possibility that it contributes to depression or suicidal thoughts — a warning that FDA also strengthened yesterday.

But birth defects are the biggest concern with Accutane and its generic version, isotretinoin, medicine that is supposed to be prescribed only for severe acne, but that critics say too frequently is given for more minor cases.

Since the drug began selling in 1982, the FDA has reports of well over 2,000 pregnancies among users. The vast majority ended in abortion, but the FDA counts more than 160 babies born with drug-caused defects. Critics note there likely were many more pregnancies because doctors haven’t been required to report Accutane-linked pregnancies. Yesterday’s new rules mandate that they do.

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. There is also a risk for 30 days after stopping the drug.

Any woman who gets pregnant while taking the drug should stop the pills right away and notify their doctor, FDA warns.

The registry actually opens on Aug. 22, giving time for doctors, patients and pharmacies to understand how it will work before the provisions become mandatory. Wholesalers and pharmacies will have to register starting Oct. 31 or the drug’s manufacturers can no longer ship them supplies of the pills.

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