A new study on the side effects of Accutane published in the American Journal of Gastroenterology suggest that the acne drug may increase the risk of developing bowel problems. The findings come just weeks after a New Jersey jury awarded an Alabama man $25.16 million because they believed Roche’s Accutane caused the man to develop inflammatory bowel disease (IBD), a group of digestive disorders that includes ulcerative colitis and Crohn’s disease.
Researchers looked at data from 87 health insurance providers and found more than 8,000 people had been diagnosed with IBD. The data also showed that people taking Accutane were four times more likely to develop ulcerative colitis, and that a person’s risk of developing the disorder increased in relation to the size of the Accutane dose they were taking.
Roche is facing hundreds of lawsuits from people who say they were not adequately warned of side effects of the drug, claiming they suffered from a host of problems including bowel problems, depression and birth defects. To date, Roche has lost all six cases that have gone to trial, with jury awards totaling $56 million. Accutane is used by more than 16 million people worldwide since it was first introduced in the 1980s as a treatment for severe acne. Last June, Roche discontinued Accutane in the United States, citing mounting legal costs as the reason for the recall.
Earlier this year, Health Canada issued a warning about the safety of Accutane, saying it had received 66 reports of a rare but life-threatening allergic reaction known as Stevens Johnson Syndrome (SJS) in people who used Accutane. The reports involved both children and adults, and resulted in two deaths.