June 29, 2009. Hoffman-La Roche (Roche) pulled its popular acne medication, Accutane ®, off the market. The drug can have extremely serious side effects, including depression, psychosis and suicide. The FDA has required Hoffmann-La Roche to change their label for Accutane ® many times. The most recent label added a warning that Accutane ® was associated with inflammatory bowel disease, including Crohn's disease and ulcerative colitis in patients without a prior history of intestinal disorders. In some instances, symptoms were reported to persist after Accutane ® treatment had stopped. Accutane ® can also cause severe, life-threatening birth defects if the mother takes the medication during pregnancy.
Although Roche stands by its product, the decision to pull the drug off the market came after juries awarded at least $33 million in damages to users who blamed the drug for bowel disease. Individuals with inflammatory bowel disease have significantly higher risks of colon cancer than in the general population.
Accutane ® (also known as Isotretinoin) was first marketed by Roche in 1982 for patients with severe acne. A vitamin A derivative, Accutane ® was administered orally in pill form, normally for 3 to 5 months. It was originally prescribed for people with severe acne that did not respond to other treatments, but had gained in popularity in the past 25 years and prescribed more and more frequently for less severe acne. The FDA did not recall this dangerous drug. Generic versions of Isotretinoin are still being marketed under these names:
- Amnesteem
- Claravis
- Sotret
If you or someone you love were injured after using Accutane ® or a product containing Isotretinoin, you have valuable legal rights. Please fill out our online form, or call 1-850-444-9500 to discuss your rights with one of the experienced product liability attorneys at our firm.