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Despite time on the market Accutane continues to cause birth defects
-April 26, 2004
Accutane was approved in 1982 as a prescription medication for severe or cystic acne. While Accutane labels warned pregnant women should not use the medication, the FDA and manufacturer Roche was criticized for failing to adequately convey the dangers of the drug to women if becoming pregnant. By 1999, reports showed nearly three out of every 1,000 American women between the ages of 15 and 44 were using Accutane.
It was not until a program was launched in April 2002 designed to reduce the number of pregnant women taking Accutane that dangers began to be addressed. Despite the attempts, Public Citizen consumer group told the FDA in February 2004 that the efforts had failed and an Accutane recall should instead be implemented. During the first year of the program, 79 percent of reported pregnancies ended in elective abortions because of concerns about the high rate of birth defects caused by Accutane.
The FDA held Accutane hearings in late February to consider stricter regulations on Accutane. A nonprofit group that conducts research on effects of drugs and chemicals on the human fetus had presented the FDA with preliminary findings from a women's survey in the U.S. and Canada that had been using Accutane when they became pregnant. The group felt only the most stringent Accutane restrictions would prevent Accutane pregnancy birth defects.
The FDA has agreed to review recommendations for a national registry system, which would require that all Accutane patients enroll. The program would better ensure prescriptions for women would only be filled with a negative pregnancy test and written instructions by the doctor to use two forms of birth control while on Accutane.
For more information on Accutane, please contact us.
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