Study adds fuel to mandatory isotretinoin registry

National report - Despite industry's and the profession's best efforts, some patients taking isotretinoin are still not heeding warnings concerning pregnancy, a new study shows.

While it is still too early to measure the success of the Food and Drug Administration (FDA)-mandated iPLEDGE system for patients and providers of isotretinoin begun at the end of last year, a study done by the Birth Defects and Genetics Program at the Utah Department of Health, underscores some patients' casual attitudes toward the drug's danger if used while pregnant.

"Forty-nine percent of all pregnancies in the United States are unplanned," says Julia Robertson, a study co-author and coordinator of the Utah Genetics Program in Salt Lake City, whose department works closely with the FDA and Covance, Inc., a drug development services company selected by the FDA to run the program, to further regulate isotretinoin.

Instigated by a notable increase in inquiries from women regarding the risks of Accutane (Hoffman-LaRoche), the Birth Defects and Genetics Program began a study of 34 women who became pregnant while using isotretinoin. (This study predates the iPLEDGE registry). The survey found that manufacturer-recommended guidelines were often not followed, placing pregnant women at risk for babies with severe birth defects, in addition to doubling their risk for premature delivery.

Among the 34 pregnant women in the survey, all but three were prescribed isotretinoin, yet only 11 were taking the drug for severe, nodular acne. Eighteen of the women signed an informed consent form, and most received the drug from dermatologists and recalled receiving birth defect risk information from the package inserts. Only eight recalled receiving personal counseling about potential risks before starting the drug. Eight participants did not have two pregnancy tests before starting the drug; only six used two forms of birth control as recommended; and 19 women recalled submitting valid negative pregnancy tests before renewing their prescriptions each month.

In follow-ups of pregnancies of the study's participants, 14 (41 percent) ended in abortion and three resulted in miscarriage. Twelve (35 percent) delivered babies, with one having severe heart defects and seizures, the study reports.

Managing a timely issue

The iPLEDGE system is a computerized registry that is designed to prevent fetal exposure to isotretinoin. The FDA required wholesalers and pharmacies to register to obtain the drug beginning December 30 of 2004. Patients and prescribers have until February 28, 2006 to register and comply with requirements in areas including office visits, counseling and birth control.

Starting March 1, only prescribers registered and activated in iPLEDGE can prescribe isotretinoin and only patients registered and qualified in iPLEDGE can be dispensed the drug.

"If the iPLEDGE system is successful in reducing pregnancy exposures to isotretinoin, then that would be a success," says Diane Thiboutot M.D., chair of the American Academy of Dermatology (AAD)'s Isotretinoin Ad Hoc Task Force. "But, we can't legislate sexual practice and behavior."