122 Pregnancies Reported Among Women Participating In Accutane IPledge Program

Main Category: Dermatology
Also Included In: Pregnancy / Obstetrics;  Pediatrics / Children's Health;  Women's Health / Gynecology
Article Date: 03 Aug 2007 - 3:00 PDT

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New figures released on Monday from the FDA-sponsored iPledge program that aims to prevent pregnancies among women using the acne drug isotretinoin, show that 122 women participating in the program reported a pregnancy in 2006, the AP/USA Today reports (Neergaard, AP/USA Today, 7/30). Studies have shown that isotretinoin, sold by Roche under the brand name Accutane, 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 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 pregnancy test before each monthly 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 the risk for birth defects, depression and suicidal thoughts (Kaiser Daily Women's Health Policy Report, 3/30).

According to a report conducted by isotretinoin manufacturers, more than 305,000 people registered to use the drug, including 137,415 women of childbearing age. iPledge allowed 91,894 people to receive at least one prescription, the report found. According to the report, 78 women became pregnant while taking the drug, eight became pregnant within one month after they stopped taking the drug, and 10 were already pregnant before taking it, including two who had pregnancy tests falsified.

Most of the 122 pregnancies were a result of women not adhering to their birth control plans, the report found. According to the report, 72% of the women who used the drug said they were using birth control pills and a male condom, and 18% said they had relied on abstinence.

According to the AP/USA Today, a similar number of pregnancies were reported before FDA tightened regulations on the drug. However, Sandra Kweder, deputy director of FDA's Office of New Drugs, said that comparisons to previous years are difficult because officials were not sure if they knew of all pregnancies among women who used the isotretinoin before iPledge. An agency advisory committee on Wednesday is scheduled to meet to determine the efficacy of the program, the AP/USA Today reports. Kweder said it is uncertain why there are pregnancies among women enrolled in the program, adding, "Our goal, of course, is zero" (AP/USA Today, 7/30).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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