Side Effects of Accutane May be Reduced with Lower Doses: Study

The findings of a new study indicate that some of the side effects of Accutane may be dose-specific, and could possibly be avoided if lower doses of the acne medication are used. 

The Accutane study, conducted by New Zealand researchers, was published in the online edition of the Australasian Journal of Dermatology on June 23. Researchers found that patients given under 0.25 mg per day showed markedly fewer Accutane side effects than those given higher doses.

Accutane (isotretinoin) has been used by more than 16 million people worldwide since it was first introduced in the early 1980s as a treatment for severe acne. Roche discontinued the drug in June 2009, citing cost of defending Accutane lawsuits as a factor in their decision. However, the acne medication remains available as a generic sold under a variety of names, such as Claravis, Sotret, Amnesteem and generic isotretinoin.

In the latest study. researchers looked at 1,743 patients who used Accutane or generic isotretinoin over a six-year period. Only 18.5% of those patients, less than one-fifth, reported having no adverse effects at all. The most common adverse effect, suffered by 78% of users, was cheilitis, which causes inflammatory lesions on the lips. The other most common side effects included eczema and tiredness, each reported by about 12% of users. Three patients in the test complained of severe adverse effects, but continued taking the drug, while 24 others dropped out due to the severity of problems with Accutane.

Researchers discovered that the number of side effects from Accutane dropped considerably when the dosage was dropped from 0.75 mg per day to 0.25 mg per day. Chelitis went down to 47%, eczema reports declined to only 7% and tiredness reports dropped to 5%.

Roche faces nearly 1,000 lawsuits over inflammatory bowel disease from Accutane, which involve allegations that the drug maker failed to adequately warn users about the risk of debilitating bowel problems from Accutane, such as ulcerative colitis and Crohn’s disease. The company has lost all six Accutane bowel disease trials that have reached a jury so far, with verdicts totalling $56 million.

In April, a study published in the American Journal of Gastroenterology found that Accutane side effects quadruple the risk of ulcerative colitis. Researchers found that not only were those taking Accutane four times more likely to develop ulcerative colitis, but they also determined that the chance of developing the bowel disorder rose in relation to the size of the Accutane dose, strengthening the evidence of a causal relationship.