FDA Recommends Making Accutane iPledge Program More Flexible

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An FDA advisory committee on Wednesday voted 18-0 to recommend more flexibility for the agency-sponsored iPledge program, which aims to prevent pregnancies among women using the acne drug isotretinoin, the Wall Street Journalreports. The recommendation comes after updated figures released by thepanel on Wednesday show that 178 out of 102,606 women participating iniPledge became pregnant between March 1, 2006 and June 2007 (CorbettDooren, Wall Street Journal, 8/2).

Studies have shown that isotretinoin, sold by Rocheunder the brand name Accutane, can cause severe side effects inpregnant women, such as birth defects and fetal death, and also mightcause depression and suicide. FDA in 2004 released data that showedstrict measures enacted to reduce the number of birth defects relatedto isotretinoin had little effect on the number of women who take thedrug while pregnant.

The agency on Dec. 30, 2005, began toregister physicians, prescription drug wholesalers, pharmacists andwomen into iPledge, which requires that women submit two negativepregnancy tests before they can receive an initial prescription forisotretinoin. In addition, women must undergo a pregnancy test beforeeach monthly refill and must agree to either use two forms of birthcontrol at the same time or to abstain from intercourse for one monthprior to treatment with isotretinoin, during treatment and for onemonth after treatment has ended, according to FDA. Women also must signa document to acknowledge that isotretinoin can increase the risk forbirth defects, depression and suicidal thoughts.

According to areport conducted by isotretinoin manufacturers, more than 305,000people registered to use the drug in 2006, including 137,415 women ofchildbearing age. According to the report, 78 women became pregnantwhile taking the drug, eight became pregnant within one month afterthey stopped taking the drug, and 10 already were pregnant beforetaking it, including two who had pregnancy tests falsified.

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Mostof the 122 pregnancies were a result of women not adhering to theirbirth control plans, the report found. A similar number of pregnancieswere reported before FDA tightened regulations on the drug, but SandraKweder, deputy director of FDA's Office of New Drugs, has said thatcomparisons to previous years are difficult because officials were notsure if they knew of all pregnancies among women who used theisotretinoin before iPledge (Kaiser Daily Women's Health Policy Report, 8/1).

Recommendations

The panel recommended that women who do not fill a prescription ofAccutane within seven days of a pregnancy test should be allowed toreceive another test and then fill the prescription, the AP/International Herald Tribunereports. Current policy mandates that those who do not fill theprescription within seven days of a pregnancy test are kept out of theprogram for 23 days, the AP/Herald Tribune reports.

Thepanel also suggested that women should be required to fill theprescription within seven days of a pregnancy test, rather than withinseven days of first seeing a physician. It also recommended encouragingwomen who start the program to provide detailed follow-up informationif they become pregnant. Cynthia Kornegay of FDA's drug risk evaluationoffice told the panel that only 10% of the 122 women who becamepregnant provided such information (AP/International Herald Tribune, 8/1).

Thepanel said that the administrative changes FDA is proposing should makethe program easier to comply with and not affect the pregnancy rate.According to the Journal, FDA likely will adopt the panel's recommendations (Wall Street Journal, 8/2).

Reprinted with permission from kaisernetwork.org. You can view theentire Kaiser DailyWomen's Health Policy Report, search the archives, and sign up for emaildelivery at kaisernetwork.org/email. The Kaiser Daily Women's Health Policy Report is published for kaisernetwork.org, afree service of The Henry J. Kaiser Family Foundation.

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