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January 1, 2001 - Suicide Link: More FDA regulations, designed to protect patients, are coming for acne medication

January 1, 2001 - Suicide Link: More FDA regulations, designed to protect patients, are coming for acne medication

In the two decades since isotretinoin introduction as acne drug, dangers of drug defects and psychiatric disorders have increasingly stalked patients, providers, regulators and the manufacture, Hoffmann- La Roche. Suggestions of a link between suicide and Accutane were given added attention in October when the U.S. Rep. Bart Stupak (D, Mich.) spoke on NBC-TV's "The Today Show" and blamed the drug for the death of his 17-year-old son. Stupak's son was using Accutane for seven month when he died of a self-inflicted gunshot wound. The Food and Drug Administration (FDA) has received 41 reports of suicide among Accutane users. In response, the FDA is issuing a number of requirements on Roche, including changes to the informed-consent form and registry for both parents and prescribers.

Everyone in the medical community, however, does not support the new changes. Douglas C. Jacob, M.D., an associate professor at Harvard Medical School and expert consultant to Roche, believes "the current scientific evidence does not support a link between isotretinoin and depression, suicidal ideation, or suicide."

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