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David Mittleman
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Accutane Acne Medication Pulled from U.S. Market

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Roche Holdings AG, the maker of the acne medication Accutane, is pulling the product from the U.S. market, citing “economic reasons”. However, juries have awarded at least $33 million in damage after consumers complained of developing inflammatory bowel disease from using Accutane. The drug has also caused birth defects and depression. In fact, the company faces as many as 5,000 personal injury claims over Accutane.

Roche began a tracking program in 2002 designed to reduce the number of pregnant woman taking the drug. However, the tracking program was largely unsuccessful. Nearly 80% of pregnancies reported by women taking Accutane during the tracking program’s first year had elective abortions because of concerns about birth defects including microphaly (small head and brain), hydrocephaly (enlargement of the fluid-filled spaces in the brain), mental retardation, heart defects, ear and eye abnormalities, cleft lip and facial abnormalities.

Moreover, Bart Stupak, a Michigan Representative, wrote a letter to Health and Human Services in 2004, pleading the agency to take the drug off of the market because of the dangerous depression symptoms it causes. Stupak’s 17-year-old son, Bart Stupak Jr., committed suicide in May 2000 after taking Accutane.

About 13 million people have used Accutane since it came onto the market in 1982. It was Roche’s second-best selling drug before the patent expired in 2002 and generic versions flooded the market. Roche says its share of the drug is below 5% now. The drug has been pulled off the market in 11 other countries, including France, Denmark, Austria, Portugal, Norway and Spain. Roche maintains that it did not pull the drug from the U.S. market because of side effects. Instead, the company says it was forced to remove the product because of the multiple lawsuits it faces and the competitive strength of the generic market.