Acne drug linked to suicide risk

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For teenagers, having acne can be depressing enough. However, reports say that a drug called Accutane which is being marketed as a "cure" for acne, can cause "depression, psychosis, and rarely suicidal thoughts and actions."

The U.S. Food and Drug Administration (FDA) warned doctors and consumers about the risk in a statement on Feb. 25, 1998.

The FDA and Hoffmann-La Roche, the pharmaceutical company that markets the drug, said they'll put a warning label on the drug -- but will continue marketing it to teenagers and other individuals for acne.

Reports of such severe psychological side effects have been sent to the FDA for more than a decade, the government agency admitted.

Information about depression was included in Accutane labeling in 1986, but it was hidden away in the complex "warning section" of the full drug information sheet given to doctors.

Ironically, the drug maker tried to convince the FDA that it had taken the warning off the labels, where patients would see it, and put it in the sheet because "it captures the attention of physicians more readily," said Eileen Leach, medical director of dermatology products for Hoffmann-La Roche.

As in the case of most dangerous or even potentially deadly drugs, however, the FDA refused to take Accutane off the market. Instead, the agency merely suggested that doctors should "think about these things when caring for patients for whom they've prescribed Accutane," said Jonathan Wilkin, director of the FDA's division of dermatologic and dental drugs.

SOURCE: "Important New Safety Information about Accutane," Food and Drug Administration, Feb. 25, 1998.

The Chiropractic Journal.

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