By Stuart Brown – 12th Oct 2015
Accutane (isotretinoin) is used to treat a severe type of acne, which causes swollen, red, tender bumps on the skin that can potentially end up leaving the skin scarred. The drug was first licensed by the FDA in 1982, but has had a troubled history with side effects, particularly as the likely cause of 173 suicides worldwide (up to 2002) as well as birth defects.
The original makers of Accutane, Hoffmann-La Roche, stopped selling the drug in the United States in 2009. This has been claimed to be purely a financial decision because the Accutane patent expired in 2002 and quickly had generic (isotretinoin) versions competing for market share. This is true to an extent. Market share for the drug had fallen to less than 5% in the U.S by 2009, but it seems a curious decision to remove a long-established brand from the market, especially as they still sell it in other countries, particularly the U.K, under the name Roaccutane.
Less well known however are the increasing amount of cases that are emerging linking Accutane (isotretinoin) and IBD (Inflammatory Bowel Disease), a condition which according to the Lancet in a Dec 2014 article, accounted for 51,000 deaths worldwide in 2013. IBD covers a range of conditions that affect the small intestine and the colon. These include ulcerative colitis, where patients suffer from ulcers in the colon as well as inflammation, and Crohn’s disease, which affects the gastrointestinal tract.
The American Journal of Gastroenterology in September 2010 published a case-control study that analysed an insurance claims database that comprised 4,428 people with ulcerative colitis, 3,664 with Crohn’s disease, 97 with an unspecified form of IBD and 21,832 control subjects.
The study concluded that there was a link between an increased risk of developing ulcerative colitis and taking isotretinoin. However, it did not establish the same link with Crohn’s disease.
“In this case control analysis of administrative claims data from a large, commercially insured US population including >8,000 cases of IBD, we found that previous isotretinoin exposure was associated with an increased risk of UC, but not CD. There seemed to be substantial evidence of a “dose – response” relationship for UC.”
The link between developing ulcerative colitis and taking Accutane has been tested in the U.S courts now on many occasions and substantial multi-million dollar judgements have been forthcoming.
One of the largest such judgements was for $25 million in Sept 2011 to Andrew McCarrell who had been pursuing a case against Hoffmann-La Roche in trials and re-trials since 2007. He had taken Accutane for acne in his 20s and was diagnosed with IBD because of using the drug, which eventually led to four surgeries and the removal of his rectum and colon. He was originally awarded $2.6 million in 2007, but La Roche sought out and got a new trial, which they then proceeded to again lose and have the amount increased almost ten-fold when the judgement was upheld.
Judge Higbee, who presided in the second case, noted that Andrew McCarrell had suffered “a picture of probably the worst case of pain, suffering and loss of quality of life I ever heard described in my eighteen years on the bench.”