Registry for Accutane Debuts

The Associated Press January 1, 2006

WASHINGTON - A national registry is now accepting names of Americans who take the anti-acne drug Accutane as part of a federal effort to limit use of the birth-defect-causing drug by pregnant women.

Doctors, wholesalers and pharmacies had until Friday to register with the computerized "iPledge" registry in order to continue prescribing or selling Accutane and any of the three generics known as isotretinoin. Generic versions are sold as Amnesteem, Claravis and Sotret.

The Food and Drug Administration has tried for more than 20 years to limit the exposure of fetuses to the drug, prescribed to 100,000 Americans a month.

If a woman uses Accutane during pregnancy, her baby runs a significant risk of suffering brain and heart defects or mental retardation. Patients typically take the drug for five to six months.

Despite warnings, anywhere from 100 to 140 pregnancies a year are still reported in women on the drug, said Dr. Paul Seligman, director of the FDA office responsible for post-marketing drug surveillance.

Since Accutane sales began in 1982, the FDA has received reports of more than 2,000 pregnancies among users. The vast majority ended in abortion or miscarriage, but the FDA counts more than 160 babies born with drug-caused defects.

All Accutane users must enroll and sign a document informing them of the drug's risks, including the possibility that it contributes to depression or suicidal thoughts.

Additionally, female patients must undergo two pregnancy tests before they can be prescribed the drug, along with a monthly follow-up test before each refill. They also must agree to use two different forms of birth control at the same time or not to have intercourse for one month before starting isotretinoin, during treatment and for one month after treatment, according to the FDA.

Pharmacists will have to check a computer database before filling a prescription to ensure patients are in compliance.

The iPledge registry replaces and builds on previous programs run by the four manufacturers.

TO SIGN UP

All Accutane users must enroll at (866) 495-0654 or at www.ipledgeprogram.com to receive the anti-acne drug.