People who had filled four or more prescriptions of Accutane had over twice the risk of inflammatory bowel disease and the odds of developing ulcerative colitis were four times higher. The actual risk of IBD is quite low but the risk of lawsuits is apparently driving Roche to withdraw the drug from the market.
The study bolstered evidence of a link between the drug, pulled from the market in June, and inflammatory bowel disease. No medication is as effective in treating severe cases of acne.
Swiss-based Roche Holding quietly pulled its blockbuster drug Accutane off the market in June amid early signs that the drug may be linked to inflammatory bowel disease. And last week, a study was released that quantified those risks, finding that users of the medication have almost twice the odds of developing a serious bowel disorder as nonusers.
When approved in 1982, the drug was known to cause birth defects if taken during pregnancy and was labeled with warnings to that effect. In 2005, the Food and Drug Administration implemented the stringent iPledge program, requiring patients, doctors and pharmacists to join a risk-management registry to try to ensure that women didn't become pregnant while on the drug.
Isotretinoin can cause other side effects, including increased sensitivity to the sun, joint and muscle pain, headaches, thinning hair, elevated cholesterol and liver toxicity.
New study may deal final blow to acne drug Accutane