HEALTHFDA panel backs patient registry for acne drugTracking women who take isotretinoin is part of an ongoing effort to protect against congenital anomalies.By Victoria Stagg Elliott, amednews staff. March 22/29, 2004. A Food and Drug Administration advisory committee recommended in February that all patients who take isotretinoin as well as health professionals who prescribe and dispense it become part of a mandatory, manufacturer-proposed registry. Also, women would be unable to get the drug without a negative pregnancy test. The registry is the latest idea for reducing the number of pregnant women exposed to the drug, which has long been linked to severe congenital anomalies. As part of this approach, both men and women would also receive extensive education about this risk. A voluntary registry was launched in 2001, although it appears to have had little impact. "We're trying to keep the drug available, but also to do whatever we can to reduce the risk relative to pregnancies," said Carolyn Glynn, spokeswoman for Roche Pharmaceuticals, manufacturer of the name-brand drug, Accutane. Physicians praised the efforts attempting to keep this drug safely on the market but expressed concern that such action may increase the time necessary it takes them to prescribe the drug without addressing issues related to taking it while pregnant. The registry requirement may also decrease the number of doctors willing to prescribe it and increase the number of patients who buy it outside the United States or over the Internet. [...]Full text of American Medical News content is available to AMA members and paid subscribers.
Copyright 2004 American Medical Association. All rights reserved.
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The doctors are in the house
The AMA's House of Delegates is holding its Interim Meeting Nov. 7-10 in Houston, addressing issues such as health system reform and physician payment. Meeting coverage - Slideshow Feature articlesHealth reform review The Massachusetts experience Litigation stress Being sued is personal as well as professional Comprehensive coverage
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