CHICAGO (AP) — Accutane, the powerful acne drug already known to cause birth defects, seems to raise the risk of heart and liver problems more than doctors had expected, according to a study.
The findings came from laboratory tests on 13,772 patients taking the popular drug and underscore the need to closely monitor people taking isotretinoin, which is sold as Accutane and in three generic versions. Abnormal results for cholesterol and liver function were more common than expected.
Although those conditions can lead to problems in the long term, abnormal lab tests don’t necessarily mean patients will develop heart or liver problems, said study co-author Dr. Lee Zane of the University of California at San Francisco.
“An elevation in cholesterol doesn’t guarantee a heart attack. A high level of liver enzymes doesn’t mean cirrhosis of the liver,” Dr. Zane said.
Further studies would be needed to determine long-term health effects, he said. In the current study, most patients’ abnormal results returned to normal when they quit taking the drug.
Patients usually take it for less than a year, at a cost of $10 to $15 per daily pill. It’s considered one of the most effective treatments for the severest acne.
On March 1, the Food and Drug Administration (FDA) began requiring patients and doctors to register their use of the drug, a program intended to stop birth defects.
Isotretinoin can cause brain and heart defects in infants if a woman takes it during or immediately before pregnancy. More than 71,000 patients have registered with the FDA. Women who take it must have pregnancy tests and use birth control or abstain from sex.
Most dermatologists already knew the drug also could increase levels of cholesterol, liver enzymes and blood fats called triglycerides that can raise the risk of heart disease. But the study found higher than expected percentages of patients developing these abnormal lab results.
Among patients with normal lab results before they started taking the drug, 44 percent developed high levels of triglycerides. The package insert, by contrast, cites high levels of triglycerides in 25 percent of patients.
Thirty-one percent of healthy patients in the study developed high cholesterol levels, and 11 percent had abnormal liver tests.
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