Acne Drug Accutane Ups Cholesterol
Lipid Levels Return to Normal After Treatment Ends
Aug. 21, 2006 -- There are new safety concerns about the controversial prescription acneacne drug Accutane.
In a study involving almost 14,000, mostly young patients taking the drug, elevations in blood cholesterol, triglyceridestriglycerides (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 of miscarriagemiscarriage and 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.
The reproductive risks have been well described, but less is known about the drug's impact on cholesterol, triglyceride, liver test, and other critical blood levels.
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.