July 8, 2009 -- Accutane won't be sold any more, drug giant Hoffmann-La Roche Inc. has announced.
Generic versions of the acne drug, called isotretinoin, are still available from several manufacturers. But Roche, which has sold the drug to 13 million patients since 1982, will not be one of them.
The decision was made for "business reasons," Roche announced in a news release. Those reasons include declining sales: Accutane sales now make up less than 5% of the isotretinoin market.
Another big reason: Personal injury lawsuits, which Roche is aggressively defending.
Accutane and other isotretinoin products are effective treatments for serious acne. But the drug can have extremely serious side effects: mental health problems -- including depression, psychosis, and suicide -- and, when taken by pregnant women, miscarriage or birth defects.
Roche has an aggressive program, iPledge, to prevent use of Accutane by pregnant women, including signed pledges to use two forms of effective birth control.
"Roche stands behind the safety of Accutane and the rigorous risk management program Roche developed over decades of cooperation with the FDA and the American Academy of Dermatology," the company says in its news release.
Roche says it will work with the FDA and the remaining isotretinoin makers to transfer responsibility for the risk management program to new sponsors.