Aug. 21, 2006 -- There are new safety concerns about the controversial prescription Accutane.drug
In a study involving almost 14,000, mostly young patients taking the drug, elevations in blood cholesterol, (a blood fat), and a blood liver function test were more common than have been previously reported.
Blood levels returned to normal or to pretreatment levels in the vast majority of patients in the months after they stopped taking Accutane, however.
Researchers say this finding is reassuring, but they add that patients should be followed longer to see if there are long-term implications for cardiovascular and liver disease risk.
"We do want to know if there are long-term consequences, but that was not a part of this research," researcher Michele Manos, PhD, MPH, tells WebMD.
Tighter Controls on Drug
First approved in 1982 for the treatment of severe disfiguring acne, Accutane use in women has long been linked to an increased risk ofand birth defects.
Last August, the FDA announced tough new regulations to reduce what government researchers estimate are hundreds of miscarriages and birth defects each year among women of childbearing age who take the acne medication.
In the first large study to examine the issue since the drug was approved, Lee T. Zane, MD, of the University of California, San Francisco, along with Manos and other colleagues, evaluated laboratory abnormalities among 13,772 patients with severe acne who were treated with Accutane between 1995 and 2002.
The average age of the patients in the study was 19; roughly half were female.
When the researchers analyzed the medical records of each patient before, during, and after treatment with Accutane, they found clinicians did a good job of monitoring their patients' blood levels to look for potential problems.
Changes in Blood Levels
Those problems included a 44% rise in triglyceride levels among patients with normal pretreatment levels, a 31% rise in total cholesterol, and an 11% rise in liver enzyme levels.
No significant changes were seen in levels of infection-fighting white blood cells, oxygen-carrying hemoglobin, or blood clotting platelets.
Liver enzyme levels returned to normal within three months after treatment in 92% of the patients who continued to be monitored. Cholesterol levels returned to normal during the same period in 79% of patients, and triglyceride levels returned to normal in 80% of patients.
"This was definitely some good news from this study," Manos says. "The findings suggest that routine monitoring of white blood cell and hemoglobin levels may not be needed."
'Not a Surprise'
American Dermatology Association president Stephen P. Stone, MD, tells WebMD the study appears to confirm what he has seen clinically.
Becausepatients who take Accutane are treated with the drug for only a few months and tend to be young, Stone says it is unlikely there are long-term cardiovascular risks associated with the drug's use.
"This is not a surprise," he says. "We have known about these elevations since before the drug came on the market, and those of us who use it monitor patients very carefully."
Accutane manufacturer Roche Pharmaceuticals notes that prescribing physicians are advised to monitor patient blood levels before treatment and at least once every two weeks during treatment until it becomes clear if the drug will affect cholesterol-triglyceride levels.
"When this drug first came on the market we really had little to offer patients with severe, scarring acne," Stone says. "I would say that better than 90% of the patients we treat with Accutane show significant improvement, if not complete [acne] clearing."