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Accutane pulled from market
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The best-known brand of a medication for treating recalcitrant acne is being withdrawn from the U.S. market. Roche cited shrinking market share as the reason for its decision to stop making and selling Accutane.
Accutane contains the drug isotretinoin, which is also available in Amnesteem from Genpharm and Mylan, Claravis from Teva-Barr, and Sotret from Ranbaxy. Currently, fewer than 5 percent of isotretinoin prescription get written for Accutane.
Roche stressed that widely recognized mental health, pregnancy and gastrointestinal risks for isotretinoin did not prompt its move to pull Accutane, even though it acknowledged that is facing "high costs from personal-injury lawsuits that the company continues to defend vigorously."
Roche and the other makers of isotretinoin products cooperated with the U.S. Food and Drug Administration earlier this decade to develop and implement a prescriber training and patient education program to minimize risks from using isotretinoin. That program, iPLEDGE, limits supplies of the acne drug to 30 tablets at a time, requires that all patients receive intensive counseling about the medication, and blocks the dispensing of isotretinoin to any female patient who cannot document a recent negative pregnancy test.
Rarely, suicidal thoughts and attempts have been reported among isotretinoin users. More frequently, isotretinoin has produced birth defects when used by pregnant women.
Roche said it "stands behind" iPLEDGE and claims that Accutane has been used safely by more than 13 million patients since the product's launch in 1982.
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