After two decades on the market, numerous safety warnings and other restrictions have failed to prevent babies from being born with birth defects because their mothers take Accutane. In an unprecedented move, the U.S. Food and Drug Administration announced on August 12, 2005, that patients who take Accutane, a drug for the prevention of acne, must enroll in a national registry in order to continue receiving the drug. Doctors who prescribe the pills must also register, as must drugstores and wholesalers who stock the drug on their shelves. The new FDA regulations begin December 31, 2005.

Registrants in the net iPLEDGE computerized registry must sign a document indicating they understand Accutane’s risks. Risks from Accutane, besides severe brain and heart defects in unborn fetuses, include depression and suicidal behavior. Patients must agree to monthly doctor visits for refills and agree not to share the pills with anyone. Registrants are then given a special identifying code number.

Women of childbearing age must undergo two tests to ensure they are not pregnant before their initial prescription for Accutane and undergo monthly pregnancy tests in a doctor’s office before picking up each refill. Their doctor must enter the pregnancy results into the iPLEDGE system, and the woman must then buy her pills within seven days after her pregnancy test.

Women must also agree to use two forms of birth control while using Accutane and must self-register on iPLEDGE to report they are doing so. Pharmacists who fill Accutane prescriptions must check the iPLEDGE database before filling prescriptions. The iPLEDGE registry opens August 22.

Since Accutane began selling in 1982, the FDA has received reports of over 2000 pregnancies among users. The vast majority ended in abortion or miscarriage, but the FDA counts more than 160 babies born with drug-caused defects.

Source: “FDA Tightens Accutane rules,” USA Today, August 12, 2005.