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Accutane® is an acne medication that was approved as a last resort for the most severe instances of acne. First available in 1982, there have been links to Accutane® side effects, especially in pregnant women. Females who are on Accutane® during their pregnancy risk serious birth defects, including severe brain and heart defects, mental retardation, as well as other risks. The FDA has been widely criticized for its failure to implement stricter restrictions on the drug even in light of the continued reports of Accutane® pregnancy.

Petition to Place Warning on Accutane®

Public Citizen consumer group petitioned the FDA to give patients warning information with the drug in 1983. This was just one year after Accutane® was released. The length of time Accutane® has been on the market, along with the continuation of Accutane® pregnancy reports being made, was the reason the consumer group later petitioned for an Accutane® ban in 1988. Numbers show that about 25 percent of Accutane® pregnancy births will result in serious birth defects and 50 percent of the Accutane® pregnancy births will result in mental disability.

Due to the high rate of birth defects, the majority of women that have an Accutane® pregnancy choose to have an abortion. It is estimated that 26 times more women than necessary are prescribed Accutane®. In 2001, the FDA began to urge pregnancy testing and contraceptive education in hopes of reducing the number of Accutane® pregnancy reports but has also admitted it was a voluntary system that has had no effect.

Reports of Accutane® and Pregnancy

Since hitting the market, the FDA has received well over 2,000 reports of Accutane® pregnancy. The actual Accutane® pregnancy number is believed to be much higher due to underreporting. Also, this is due to the fact that doctors are not required to report Accutane® linked pregnancies to the FDA. Warnings continued to fail to have any impact on the Accutane® pregnancy numbers so in 2001, the FDA's own advisory committee recommended a registry.

In April 2002, the FDA and Accutane® manufacturer, Hoffmann-La Roche, launched a program to reduce the Accutane® pregnancy numbers. Despite the program, within the first year, the numbers showed that there was no improvement. The inability to adequately address the problem of Accutane® pregnancies over the last twenty years that the dangers of Accutane® have been known, will lead Public Citizen to petition the FDA again, according to a February 2004 presentation.

Tighter Restrictions from FDA

Now, the FDA is debating guidelines for tighter restrictions that could finally reduce the Accutane® pregnancy and birth defects numbers. Public Citizen believes photographic evidence of severe cystic acne and proof that the patient has not responded to other acne medications should be required. In addition, women should have a written statement detailing their contraceptive practices and be able to show negative pregnancy tests.

If you are someone you love has experienced an injury from using Accutane®, please contact our experienced Accutane® lawyers now!

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