A national registry on Friday began accepting names of Americans who take the anti-acne drug Accutane, 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 generic versions of the drug, known as isotretinoin. Generic versions are sold as Amnesteem, Claravis or Sotret.
The Food and Drug Administration has tried for more than 20 years to limit the exposure of fetuses to the drug, prescribed to about 100,000 Americans a month. If a woman uses Accutane during pregnancy — or becomes pregnant within a month of taking the drug 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 those previous efforts to control its use, anywhere from 100 to 140 pregnancies a year are still being reported in women on the drug, said Dr. Paul Seligman, director of the FDA office responsible for post-marketing drug surveillance.
The iPledge registry replaces and builds on previous programs, run individually by the four manufacturers.
"We hope it will be the program that ensures that we can get as close to the goal of the least pregnancy exposures as possible," Seligman said. The registry is similar to one used for thalidomide, which also causes birth defects.
All Accutane users must enroll by telephone at (866) 495-0654 or through the Internet at http://www.ipledgeprogram.com to receive the drug.
They also must sign a document informing them of the drug's risks, including the possibility that it contributes to depression or suicidal thoughts. The drug's labels have carried a similar warning since August.
Additionally, female patients of childbearing age 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 heterosexual intercourse for one month before starting isotretinoin, during treatment and for one month after treatment has ended, according to the FDA.
Pharmacists will have to check a computer database before filling a prescription to ensure patients are in compliance. All doctors and patients must be registered and activated in the iPledge system by March 1 to prescribe and take, respectively, the drug. Manufacturers are supposed to cut off pharmacies and wholesalers that violate the rules.
The manufacturer of Accutane, Roche Laboratories Inc., said a statement on the registry's debut would be forthcoming. Messages left seeking comment with its three generic competitors, Mylan Pharmaceuticals Inc., Barr Laboratories Inc. and Ranbaxy Laboratories Inc., were not immediately returned Friday.
An American Academy of Dermatology spokeswoman said the group never supported the registry concept for the drug.
"We don't believe isotretinoin is a medication that needs a registry. The academy has spent years educating its members about it," spokeswoman Jennifer Allyn said. "We felt that adding a registry for it would prevent people who really need this medication from getting it."
Isotretinoin is supposed to be prescribed only for the most severe acne, but is widely acknowledged to be prescribed for more minor cases.
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.