FDAnews
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ACNE DRUG MAY INCREASE HEART, LIVER PROBLEMS

August 30, 2006

Roche's acne drug Accutane, already known to cause birth defects, may raise the risk for patients to develop other health problems, according to a study published in the August issue of Archives of Dermatology.

Researchers from the University of California, San Francisco and Kaiser Permanente Northern California, Oakland, found Accutane (isotretinoin) caused a greater-than-expected number of abnormal results signaling higher risk of heart and liver problems, including increased cholesterol, triglycerides (a blood fat) and levels of certain enzymes that indicate liver problems.

Genpharm, Barr Laboratories and Ranbaxy Laboratories make generic versions of the drug.

In the study of more than 13,000 patients ages 13 to 50 with normal lab tests before starting treatment, 44 percent of patients demonstrated above-normal triglyceride levels after beginning isotretinoin therapy, 31 percent had elevated total cholesterol levels and 11 percent had higher levels of the problem-signaling enzymes. Nearly all patients saw levels go back to normal after they stopped taking the drug.

Earlier this year the FDA implemented the iPLEDGE program to minimize fetal exposure to the drug, which carries a significant risk of birth defects if taken during pregnancy.