ning them that use of Accutane may be linked to a higher risk of depression and suicide.
The issue attracted national attention in May 2000, when the son of Rep. Bart Stupak (D-Mich.) committed suicide. The Congressman claimed that the acne drug was responsible, because his son had never been depressed before taking Accutane. In December 2002, before the Subcommittee on Oversight and Investigations of the House of Representatives Energy and Commerce Committee, Stupak claimed that use of Accutane remained uncontrolled, and demanded that the FDA more strictly regulate Accutane.
Another high-profile incident occurred in April 2002, when the mother of a teen-age boy who had flown a small aircraft into a Tampa, Florida office building filed a $70 million wrongful death and negligence lawsuit against Hoffmann-La Roche Inc. The lawsuit, filed in Hillsborough County Circuit Court, claims that Roche is responsible for the suicide of 15-year-old Charles Bishop, due to severe psychiatric side effects of the daily dose of Accutane he had been taking since April 2001.
In February 2002, Roche added to the Accutane label stronger language regarding possible psychiatric problems, and funded a brochure entitled "Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Accutane (isotretinoin)." Roche continues to maintain that there is no mental health concern surrounding Accutane.
Alternatives to Accutane
The Accutane patent expired in February 2002. On November 11, 2002 Genpharm announced that the FDA had approved its isotretinoin product. Bertex Pharmaceuticals markets the drug under the name brand Amnesteem, and it carries much the same warnings as those that accompany Accutane. By February 2003, Ranbaxy Pharmaceuticals Inc. began selling isotretinoin under the brand name Sotret. Each manufacturer has its own controlled distribution system, and requires sticker warnings on the prescription prior to dispensing. On April 11, 2003 generic isotretinoin from Barr Laboratories was approved by the FDA, to be marketed as Claravis.
Get Help Now
While almost all medications have some anticipated side effects, a drug manufacturer has a duty to adequately inform physicians regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as "product liability."
If you or a loved one have taken Accutane and experienced any unusual side effects or suffered injury, you should contact a physician for proper medical attention. Your next step should be to contact an experienced product liability attorney, who will assess and protect your legal rights. To learn more about an attorney's role in a product liability case, read our article on getting legal help with a product liability issue.