Accutane®, a popular acne treatment drug, was recalled in 2009 by its manufacturer, Roche Pharmaceuticals. The drug has long been under heavy scrutiny by the FDA because of the side effects of Accutane®. These side effects, and the thousands of lawsuits over the associated injuries, are likely a key factor in the voluntary recall.

FDA Approval Date for Accutane®

The FDA approved Accutane® in 1982 for use in treatment of severe acne that is unresponsive to conventional treatments. In most cases, this acne is disfiguring and painful and can leave deep scars. Accutane® was uniquely effective in treating these patients. Accutane® can, however, be associated with serious adverse side effects including birth defects, depression, and inflammatory bowel disease.

FDA Warnings Involving Accutane®

The FDA has a long history of issuing warnings regarding Accutane® , though it has never officially banned its use. In 2005 the FDA issued an alert that Accutane® contributed to suicidal thoughts and actions. Subsequently it implemented the IPledge program, which mandated continuing counseling by pharmacists and doctors as to the dangers of Accutane®.

The IPledge program was initiated after an earlier version of the program, called SMART (System to Manage Accutane® Related Teratogenicity), was found to be inadequate. Ipledge was mainly focused on preventing pregnant women from using the drug to prevent fetal birth defects. However, women who were unable to become pregnant, and even men, also had to take part in the program to ensure they understood the dangers of the drug.

Accutane® Pulled from U.S. Market

In 2009 Roche Pharmaceuticals initiated a voluntary recall, which effectively ended the sales Accutane®. However, the active ingredient in the drug, Isotretinoin, is still available in generic versions of Accutane®, marketed under several brand names including Amnesteem, Claravis, and Sotret.

These generics have been available since 2002. Despite this, Roche cited their sale at discounted prices as the main reason for discontinuing Accutane®. It is more likely, however, that mounting evidence over side effects of Accutane® use was the motive. The more serious of these Accutane® side effects include Crohn's Disease and Ulcerative Colitis.

Contact an Accutane® Lawyer

If you were a user of Accutane® who is suffering from the Crohn's Disease or Ulcerative Colitis, it is important that you contact an experienced Accutane® lawyer. You may be able to receive compensation for your injuries.