"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."
Because the data have not yet been published in a peer- reviewed journal, Crockett noted, they 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. That study examined a large database in Canada and found that 1.2% of people diagnosed with inflammatory bowel disease had used the drug before diagnosis, compared with 1.1% who had not used isotretinoin.
For The Record
Los Angeles Times Wednesday, November 11, 2009 Home Edition Main News Part A Page 4 National Desk 3 inches; 114 words Type of Material: Correction
Accutane's side effects: An article in Saturday's Section A about the possibility of the acne drug isotretinoin, best known by the brand name Accutane, being taken off the market because of side effects misstated the results of a study that compared people with inflammatory bowel disease to people without the disease. The article said the study showed 1.2% of people diagnosed with inflammatory bowel disease had used isotretinoin before diagnosis, compared with 1.1% who had not used isotretinoin. Instead, the study showed that 1.2% of people with inflammatory bowel disease had used isotretinoin before diagnosis, compared with 1.1% of people in the healthy group who had used the drug and not developed the disease.
There is no biological explanation for why isotretinoin might increase the risk of bowel disease, Crockett said, adding: "There are a lot of things that are not understood."
A statement by 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% less. Meanwhile, plaintiffs have won an estimated $33 million in judgments against Roche for bowel disorders, according to an industry publication, Dermatology Times.
The new data are certain to spark renewed opposition to the drug, said Michael S. Brown, an Encino-based lawyer who specializes in personal-injury claims.
The intent of the lawsuits is to drive the medication off the market, he said. "That has been our goal for several years or, in the alternative, to make full disclosure in a way in which the public is properly informed," he said. The isotretinoin patients he represents were not told of a potential increased risk of bowel disease, Brown said.
Taub, the Northwestern dermatologist, says she will include the most recent information on risk in her long discussions with patients who are candidates for the medication. But she worries about a future with nothing to offer people with severe acne.
"If it's financially draining, companies are going to pull out," she said.
"I would hate for anyone to develop ulcerative colitis while treating them for something like acne. But the flip side is that most people who take Accutane have suffered terribly" from acne, she added.