accutaneTeens and adults who suffer from severe, scarring acne may lose the most effective treatment to date for helping the condition. Swiss pharmaceutical company Roche Holding pulled the drug Accutane off the market in June following early reports the drug could be linked to inflammatory bowel disease. But a new study to measure those risks has found that Accutane users have nearly twice the chance of developing a serious bowel disorder as those who don’t use it. Generic versions of the drug remain available, but these latest findings could result in the withdrawal of the controversial med considered the treatment-of-last-resort for acne so bad it can lead to serious scarring of the face and a lifetime of misery. During the course of its stormy history, Accutane, also called isotretinoin, has been shown to cause serious birth defects if taken by women while pregnant, and possibly to increase the risk of depression, including suicidal tendencies. Women who use it must register with authorities, sign a form saying they understand the risks of taking it, are required to use two forms of birth control, and submit to a pregnancy test each month. A variety of vitamin A, isotretinoin is normally taken daily for three-to-six months. It results in lasting improvements in patients 99% of the time, and a cure about 70% of the time. It has also been used to treat lupus, psoriasis, and cancer. The brand Accutane has been used worldwide by more than 13 million people, and was one of the company’s best-selling drugs, with about $200 million in yearly sales prior to 2002, when its patent expired. When it was approved in 1982, Accutane was known to cause birth defects if taken during pregnancy and was labeled accordingly with warnings. In 2005, the Food and Drug Administration (FDA) put the tightly-regulated iPledge program into place, which requires doctors, pharmacists, and patients to join a registry in order to ensure that women don’t become pregnant while taking the drug. The iPledge program has kept the drug on the market, but the system is so rules-heavy that many doctors and patients have stopped trying to obtain the medication. Isotretinoin is known to cause other side effects, including headaches, increased sensitivity to sunlight, elevated cholesterol levels, muscle and joint pain, liver toxicity, and thinning hair. The drug has also linked to increased risk of depression, including suicidal behavior, and families of suicide victims have pressed the FDA to ban it, including U.S. Representative Bart Stupak, a Michigan Democrat whose teenage son committed suicide in 2000 after using Accutane. A study published in the Annals of General Psychiatry in January, however, found no relationship between isotretinoin and psychiatric problems. But research may have found a link to between the drug and inflammatory bowel disease. During the annual meeting of the American College of Gastroenterology, researchers from the University of North Carolina, Chapel Hill, presented evidence that showed a higher incidence of bowel disorders in users of isotretinoin. In inflammatory bowel disease, intestines become chronically swollen and red; they produce cramping, diarrhea, pain, cramping, weight loss and bleeding. Surgery is often necessary to remove all or part of the colon. The UNC researchers compared over 8,100 cases of inflammatory bowel disease with more than 21,000 healthy people; they found the odds of developing such diseases were 1.68 times higher among those using isotretinoin. People who filled four or more prescriptions had a 2.67 times greater risk. The chances of getting ulcerative colitis, a bowel disease that causes open sores in the colon and rectum, were 4.36 times higher among users of isotretinoin. A similar study, published in the American Journal of Gastroenterology in July by researchers from University of Manitoba didn’t find such an association. That study found that 1.2% of people diagnosed with inflammatory bowel disease had used isotretinoin before being diagnosed, compared with 1.1% who hadn’t used isotretinoin. A statement by the pharmaceutical company Roche said the decision to withdraw Accutane reflected the cost of lawsuits and other market pressures, not safety concerns. Accutane costs consumers around $1,200 a month, and many choose generics, which cost about 25% to 50% less. Meanwhile, plaintiffs with bowel disorders have won an estimated $33 million in judgments against the company. The intent of the lawsuits is to drive the medication off the market.