Roche & Accutane Drama

In June Roche, the maker of the acne drug Accutane, quietly pulled the drug off the market citing competition with generic equivalents as the reason, not problems with safety. Accutane is a very effective medication used for severe acne, but it also has many potential side effects, some very serious.

In October 2007 a Florida man who took Accutane for nine years was awarded $7 million when a jury decided that Roche did not adequately warn about Accutane's risks which helped cause the inflammatory bowel disease, Crohn's disease, in the 31-year-old man.

More recently on October 27, 2009 a Florida appeal court reversed the $7 million judgement against Roche. In a unanimous opinion the court said that the patient did not prove that the lack of adequate warning caused his disease.

Now in the latest development, in a study presented last week at the annual meeting of the American College of Gastroenterology in San Diego, researchers from the University of North Carolina, Chapel Hill, presented evidence that people who take Accutane are at a higher risk of developing inflammatory bowel disease. However, the risk of developing Crohn's disease was not increased.

The risk of developing inflammatory bowel disease is low in general. Only 5 to 10 people in 100,000 are diagnosed each year. When I think back on the patients I've prescribed Accutane to, I think most of them would have taken that chance because they were so distraught over the severity of their acne. Which is more important, the pain and suffering of severe acne or the risk of inflammatory bowel disease? I suspect the answer depends on whether you develop inflammatory bowel disease.