90% of dermatologists report having problems with Isotretinoin drug registry

Aug 30 2006

The online FDA tracking database iPledge -- with which all people taking the acne drug isotretinoin, sold by Roche under the brand name Accutane, must register to receive their prescriptions -- has caused problems for about 90% of dermatologists, according to a survey commissioned by the American Academy of Dermatology and released Monday, the AP/Sacramento Bee reports (Bridges, AP/Sacramento Bee, 8/29).

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 (Kaiser Daily Women's Health Policy Report, 8/15/05).

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 is onerous and poorly administered (Kaiser Daily Women's Health Policy Report, 8/22).

Survey Results, Reaction

The survey of 378 physicians finds that slightly more than half of dermatologists who reported problems with iPledge said they had issues with its call center.

About 80% of the physicians said their patients have had issues with iPledge, and about half of physicians reporting problems said their patients failed to fill their prescription within the seven days allowed by the program.

If patients miss the seven-day window, they are not allowed to receive another isotretinoin prescription for one month. Stephen Stone -- president of AAD, which sought to delay implementation of iPledge -- said the lockout period should be eliminated.

FDA spokesperson Susan Cruzan said the agency is working with Covance, which administers iPledge, and drug companies to improve the program.

FDA said it received no reports between Dec. 30, 2005, and March 31 of women becoming pregnant while taking isotretinoin, and Organization of Teratology Information Specialists California chapter Director Christina Chambers said the group has received a "handful" of reports on pregnancies occurring among women taking the drug (AP/Sacramento Bee, 8/29).