Studies have shown that isotretinoin can cause severe side effects in pregnant women, such as birth defects and fetal death, and also might cause depression and suicide. FDA in 2004 released data that showed that strict measures enacted to reduce the number of birth defects related to isotretinoin had little effect on the number of women who take the drug while pregnant. The agency on Dec. 30, 2005, began to register physicians, prescription drug wholesalers, pharmacists and women into iPledge, which requires that women submit two negative pregnancy tests before they can receive an initial prescription for isotretinoin. In addition, women must undergo a monthly pregnancy test before each refill and must agree to either use two forms of birth control at the same time or to abstain from intercourse for one month prior to treatment with isotretinoin, during treatment and for one month after treatment has ended, according to FDA. Women also must sign a document to acknowledge that isotretinoin can increase risk for birth defects, depression and suicidal thoughts. About 165,000 people have registered with iPledge, which is administered together with companies that sell the drug. However, critics say that iPledge poorly administered (Kaiser Daily Women's Health Policy Report, 8/30). According to the Post, problems cited by critics of the program include delays in accessing the Web site, technical issues and program staff giving patients incorrect registration information.


Susan Walker, director of the Division of Dermatology and Dental Products at FDA, said agency officials are "doing everything [they] can to maximize the efficiency of the program" and are working to achieve "a critical balance of maintaining access to the drug and ensuring its safe use" in an effort to keep a "uniquely effective" drug on the market. Washington, D.C., dermatologist Sandra Read, a board member of the American Academy of Dermatology, said, "Every single one of my patients has had a problem" with iPledge, adding, "I don't care how smart you are -- this is an extremely confusing program with a very steep learning curve." In addition, some dermatologists question why FDA has not imposed similar restrictions on other drugs known to cause birth defects, according to the Post (Washington Post, 9/5).

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