Controversy Ridden Accutane Pulled from Pharmacy Shelves
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Roche Holding AG announced last week that it is pulling its popular acne medicine Accutane from the U.S. market citing economic reasons for its decision.
Accutane was released on the market in 1982. It is estimated that about 13 million people took Accutane before the patent expired in 2002, making it Roche’s second-best selling medicine. Roche claims that after the patent expired, it faced serious challenges from its competitors reducing its market share to less than 5%.
Although the company cites economic reasons, Accutane has always been cloaked in controversy. Controversy surrounding the drug first began in the late eighties when Accutane was linked to serious birth defects.
In 2002, Roche and the Food and Drug Administration launched what became an unsuccessful tracking program designed to reduce the number of pregnant women taking the drug. Nearly 80 percent of pregnancies reported by women taking Accutane during the tracking program’s first year ended in elective abortion because of concerns over the high rates of birth defects.
Accutane has also been reported to cause psychiatric problems including depression and suicide. In 2004, lawmakers and Michigan Representative Bart Stupak sent a letter to Health and Human Services urging the agency to take the drug off the market after Stupak’s 17-year-old son committed suicide while taking Accutane four years prior. Lawyers for John Mullarkey, a 20 year old man currently facing murder charges for the death of his 16 year old girlfriend, claim that he was suffering from an Accutane fueled depression when the deaths occurred.
Roche currently faces nearly 5,000 product liability lawsuits. Recently, the company lost several lawsuits to plaintiffs who claimed Accutane caused them to develop inflammatory bowel disease. Juries have awarded over $33 million to multiple victims across the United States.
Accutane has already been pulled from the market in 11 other countries. June 25th, 2009 was the last day for distribution in the United States. Although Accutane is no longer available from Roche directly, it may still be available at pharmacies.
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