Acne drug found to raise more risks

Acne drug found to raise more risks

August 22, 2006

A powerful and popular acne drug whose use is already closely monitored because it can cause serious birth defects triggers higher levels of cholesterol and liver enzymes than previously reported, according to a study released yesterday.

The drug, isotretinoin, commonly marketed as Accutane, is a prescription treatment for severe acne, but is also known to have dangerous side effects, including depression and vision problems.

The study, published in the August issue of the Archives of Dermatology, assessed the frequency of abnormal laboratory blood tests in 13,772 people ages 13 to 50 who underwent isotretinoin treatment between 1995 and 2002.

Researchers analyzed medical records for each patient before, during and after they took the drug using information from laboratory blood tests of triglycerides, total cholesterol and liver enzyme levels.

Among patients with normal pretreatment laboratory tests, the study reported that 44 percent developed high triglycerides, 31 percent high cholesterol and 11 percent high liver enzymes while on the medicine. Lead author Dr. Lee T. Zane of the University of California at San Francisco said that previous observational studies found elevated triglycerides in the 5 to 18 percent range and elevated total cholesterol from 6 to 32 percent.

The seven-year study did not examine actual clinical outcomes for patients in the study and could not say what the elevated levels would mean over the long haul.

“Having abnormal test results does not necessarily signal the presence of a bad medical outcome,” said Zane, assistant professor of clinical dermatology. “Having elevated levels over a few months doesn’t guarantee a heart attack. It doesn’t promise liver failure. Physicians have carefully and successfully been monitoring this medicine for decades.”

Zane characterized Accutane as the “most important medication in dermatology in the last 30 years.”

“All this focus on the risks and we can lose sight of the benefits,” Zane said.

But Dr. Mark Avram, chief of dermatology at Long Island College Hospital in Brooklyn, said the study reinforced the need to remain guarded.

“Most people who take Accutane have no problem with it at all if you follow the protocol,” Avram said.

“But most people don’t take Accutane because it does have risks. But severe acne has a devastating affect on self-esteem and how a person functions. With isotretinoin, you need to be smart while you are on it.”

Shelley Rosenstock, a spokeswoman for the drug maker, Roche Laboratories Inc., said in a statement that the study findings were consistent with product information included with the drug since its approval in 1982.

“Prescribers have been advised to monitor these levels in laboratory tests … during treatment until the patient’s lipid response has been established (usually within four weeks), and consider the risk/benefit for patients for whom elevated lipid levels present a high risk,” Rosenstock stated.

In March, the Food and Drug Administration approved the manufacturer’s switch to the iPLEDGE online management program to reduce the risk of fetal exposure to the drug. To qualify for the drug, all female users, whether sexually active or not, are required to take two pregnancy tests and pledge to use two forms of birth control.

Newsday reported that some local users of Accutane had trouble signing up. The maximum recommended treatment is five months.

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