Signs of new risks might be last blow for acne treatment

Accutane often cures terrible acne, but a study suggests it raises the risk of a serious bowel disorder.

By SHARI ROAN, Los Angeles Times

Last update: November 7, 2009 - 11:57 PM

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Teenagers and young adults suffering from severe, scarring acne ultimately may lose the most effective treatment for the condition.

Roche quietly pulled its blockbuster drug Accutane off the market over the summer amid early signs that the drug may be linked to inflammatory bowel disease. And last month, a new study quantified those risks, finding that users of the medication have almost twice the odds of developing a serious bowel disorder as nonusers.

For now, generic versions are still available, but the latest troubles could lead to the withdrawal of the controversial medication considered the treatment-of-last-resort for acne so damaging it can lead to pitting of the face and a lifetime of anguish.

Lawsuits plague drugmaker

In a statement, Roche said its decision to withdraw Accutane reflected market pressures and the cost of lawsuits, not safety concerns. Accutane costs about $1,200 a month, and many consumers choose the generics, which cost 25 to 50 percent less. Meanwhile, plaintiffs have won an estimated $33 million in judgments against Roche for bowel disorders, according to an industry publication, Dermatology Times.

In its tumultuous 25-year history, the drug (also known as isotretinoin), has been found to cause serious birth defects and possibly to increase the risk of depression and suicidal behavior. Women who take it must register with the government, sign a consent saying they understand the risks, use two forms of birth control and submit to monthly pregnancy tests.

The fact that it's still on the market puzzles some former users and consumer advocates -- and reflects the profound lengths to which doctors, pharmacists, pharmaceutical companies, regulatory agencies and patients have gone to ensure its survival.

"It would be a true disaster if this medication would become unavailable," said Dr. Steven Stone, chairman of an American Academy of Dermatology committee that reviewed the drug's safety. "People don't die of acne, so it's easy to say, 'This is a drug that causes inflammatory bowel disease; let's take it off the market.' But that ignores the psychological harm of severe acne."

Lasting improvements

A form of vitamin A, isotretinoin usually is taken daily for three to six months, resulting in lasting improvements in 99 percent of patients and a cure in about 70 percent. Approved in 1982, Accutane itself has been used by more than 13 million people worldwide and was one of Roche's bestselling drugs, with about $200 million per year in sales before its patent expired in 2002.

Now, at the annual meeting of the American College of Gastroenterology in San Diego, researchers from the University of North Carolina, Chapel Hill, presented evidence showing a higher rate of bowel disorders in isotretinoin users.

Dr. Seth Crockett and his colleagues compared 8,189 cases of inflammatory bowel disease with 21,832 healthy individuals and found the odds of developing such diseases were 1.68 times higher among isotretinoin users. People who had filled four or more prescriptions had increased odds of 2.67. The odds of having ulcerative colitis, a bowel disease that causes open sores, were 4.36 times higher.

But only about five to 10 people among 100,000 per year are diagnosed with inflammatory bowel disease, Crockett said.

"The absolute risk of getting inflammatory bowel disease is very low," he said. "So if someone has disfiguring acne that was affecting their quality of life, it might be a risk they are willing to take."

But because the data has not yet been published in a peer-reviewed journal, Crockett noted, it must be considered preliminary. And a similar study, published in July in the American Journal of Gastroenterology by University of Manitoba researchers, found no such association.

There is no biological explanation for why isotretinoin might increase the risk of bowel disease, Crockett said. "There are a lot of things that are not understood."