National Registry For Accutane Users
Everyone who uses the acne drug Accutane will have to enroll in a national registry, along with every doctor who prescribes it and every drugstore that sells it — tough new restrictions aimed at preventing women from becoming pregnant with this birth defect-causing drug.
The Food and Drug Administration announced the long-anticipated program Friday, 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.
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 on Friday.
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. Friday’s new rules mandate that they do.
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.
The Food and Drug Administration announced the long-anticipated program Friday, 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.
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 on Friday.
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. Friday’s new rules mandate that they do.
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.
posted by Madison at 10:13 AM
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