New National Registry Emphasizes The Dangers Of Accutane

A national registry has begun accepting names of the tens of thousands of Americans who take the anti-acne drug Accutane as part of a stepped-up federal effort to limit use of the birth defect-causing drug by pregnant women.

Also, doctors, wholesalers and pharmacies had until December 31, 2005 to register with the computerized iPLEDGE registry 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 spent more than 20 years attempting to limit the exposure of fetuses to the drug. If a woman uses Accutane during pregnancy, or should become pregnant within a month of taking the drug, her baby runs a significant risk of suffering brain and heart defects, as well as mental retardation. Patients typically take the drug for five to six months.

Despite those previous efforts to control its use, 100 to 140 pregnancies a year are still being reported in the United States 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 in Europe in the 1950s but never was approved for use by pregnant women in the United States.

Both female and male patients must enroll on the registry to receive the drug, reports AP.
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