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Isotretinoin Use Soars in US

Originally published by Reuters Health, May 8, 2002

NEW YORK (Reuters Health) — The number of Americans using the acne drug isotretinoin (Accutane) has soared over the past decade, despite the fact that it can cause serious birth defects and may increase the risk of depression and suicide, researchers from the US Food and Drug Administration (FDA) report.

The FDA study found that prescriptions for the drug rose by 250% at drug stores between 1992 and 2000, and increased 275% in health plans between 1995 and 1999.

The investigators, led by Dr. Diane K. Wysowski, note that there was only 9% growth in the teenage population and 4% growth in the young adult population—groups most likely to use the drug—between 1995 and 2000. Therefore, population growth does not account for the increase in prescriptions of isotretinoin.

The authors also found that isotretinoin, which was approved in 1982 for the treatment of severe acne unresponsive to other treatments, is being used by individuals with mild to moderate acne. “Data indicate a trend toward increasing proportionate use of isotretinoin to treat acne that is judged to be mild or moderate in severity,” they write in the April issue of the Journal of the American Academy of Dermatology.

The researchers reviewed information from two pharmaceutical marketing research databases and from two health plan networks.

Retail pharmacies filled nearly 20 million prescriptions for isotretinoin between 1982 and 2000, with the number of filled prescriptions increasing nearly every year. Among the health plan networks included in the study, the number of prescriptions filled rose 2.75-fold from 1995 to 1999.

The drug was used to treat 5% of acne cases in the US between 1989 and 1993, and 8% of cases from 1994 to 1999. During the same period, the use of isotretinoin for severe acne decreased to 46% from 63%, and increased to 49% from 31% for mild to moderate acne, according to the report.

In January, drugmaker Hoffmann-La Roche began distributing to physicians and pharmacists updated requirements aimed at preventing pregnancy in women who take isotretinoin.