Accutane, which treats severe acne, was introduced in 1982 and has been used by more than 16 million people worldwide. After generic forms of the drug were introduced — and after lawsuits began to accumulate — the manufacturer of Accutane, Roche, pulled it from the U.S. market in 2009. Generic forms are still available.
Unfortunately, Accutane has long been linked with several severe side effects, including birth defects and suicide. Other serious side effects include inflammatory bowel disease, including Crohn’s disease.
Symptoms of Crohn’s Disease
Crohn’s disease is a type of inflammatory bowel disease that can affect all or part of the intestinal track. The disease has no cure, but it can be managed. It can cause scarring and obstruction within the bowel.
Crohn’s disease can affect the small intestine, the large intestine, or both. In fact:
- 30 percent of cases involve only the small intestine.
- 30 percent of cases involve only the large intestine.
- 40 percent of cases involve both intestines.
The most common symptoms of Crohn’s disease are:
- Low-grade fever
- Weight loss
- Prolonged diarrhea
- Abdominal pain
Crohn’s patients may also experience symptoms that are signs that the bowel is becoming narrowed because of an obstruction, such as:
- Bloating after eating
- Loud rumbling or gurgling noises coming from the stomach
Once the bowel has narrowed permanently, the patient may first experience some constipation, and eventually the constipation will become persistent. This can be caused by undigested foods becoming impacted in the bowel.
Links Between Accutane and Crohn’s Disease
Adverse drug reaction reports that Roche received through its call center were periodically evaluated in internal company documents. One of these, called the Internal Causality Assessment, issued on Jan. 6, 1994, noted that 104 cases of colitis syndromes, including Crohn’s disease, were experienced by Accutane users. Of those cases, 33 probably were linked to Accutane.
Researchers analyzed all adverse drug reaction reports submitted to the Food and Drug Administration between 1997 and 2002 and found 85 cases of IBD, including cases of Crohn’s disease, associated with isotretinoin (Accutane) use.
Here’s what they found:
- Isotretinoin use was highly probable as the cause in four cases.
- It was probably the cause in 58 cases.
- Isotretinoin use possibly caused 23 cases.
- No cases were doubtful.
Dr. R. Balfour Sartor, professor of medicine, immunology and microbiology at the University of North Carolina at Chapel Hill and chief medical adviser to the Crohn’s & Colitis Foundation of America, says that more research into the link between Accutane and Crohn’s disease is needed. He also added that Accutane is generally prescribed to patients ranging in age from mid-teens to mid-30s — a population that is more prone to developing Crohn’s disease in the first place.
Roche Pharmaceuticals has faced thousands of lawsuits filed by Accutane users. Many say they developed severe gastrointestinal disorders after taking the medication and criticize Roche for not issuing sterner warnings about the dangers of the drug.
In June 2012, a New Jersey court ordered Roche Pharmaceuticals to pay $18 million to two Accutane patients who developed bowel disease. Roche has reportedly paid out more than $50 million to Accutane patients so far, with hundreds of lawsuits still pending.