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Acne drug is linked to severe depression

Deborah Josefson, San Francisco

 The Food and Drug Administration (FDA) in the United States has warned doctors and patients that isotretinoin, a popular treatment for acne, may cause severe depression, psychosis, thoughts of committing suicide, and suicide attempts.

The warning was generated in response to reports of over 20 incidents of depression and some suicides associated with the start of isotretinoin treatment. Isotretinoin was approved by the FDA in 1982 for the treatment of nodular and cystic acne, a severe, scarring form of acne resistant to conventional medications. In practice, however, it is often prescribed for less severe acne. The drug is available in 80 countries.

Over 8 million people have used the drug, which works by reducing sebum production by sebaceous glands in the skin. The drug is a known teratogen and can be toxic to the liver; it is therefore contraindicated in pregnant women. The possible association with depression has been known for at least 12 years, and depression noted as an adverse effect on the drug label.

Eileen Leach, director of the dermatology products division of Hoffmann-La Roche, said that the company has decided to upgrade the warning about depression on the label to "capture the attention of physicians more readily." The FDA, through its Medwatch programme, had gathered "isolated reports of depression, psychosis and rarely, suicidal thoughts and actions" in patients taking the drug. Some patients reported a remission in their depressive symptoms when they stopped taking the drug.

Both the FDA and Hoffmann-La Roche emphasise that no cause and effect mechanism has been established and that the subgroup taking isotretinoin--teenagers with severe acne--may already be predisposed to depression and suicide.
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