FDA Advisory Panel Recommends Making Accutane IPledge Program More Flexible

Main Category: Women's Health / Gynecology
Also Included In: Dermatology;  Pregnancy / Obstetrics
Article Date: 07 Aug 2007 - 6:00 PDT

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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 Journal reports. The recommendation comes after updated figures released by the panel on Wednesday show that 178 out of 102,606 women participating in iPledge became pregnant between March 1, 2006 and June 2007 (Corbett Dooren, Wall Street Journal, 8/2).

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.

According to a report conducted by isotretinoin manufacturers, more than 305,000 people registered to use the drug in 2006, including 137,415 women of childbearing age. 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 already were 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. A similar number of pregnancies were reported before FDA tightened regulations on the drug, but Sandra Kweder, deputy director of FDA's Office of New Drugs, has 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 (Kaiser Daily Women's Health Policy Report, 8/1).

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

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

The panel said that the administrative changes FDA is proposing should make the 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 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.