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Suicide link

More FDA regulations, designed to protect patients, are coming for acne medication

When Accutane (isotretinoin, Hoffmann-La Roche) won clearance in 1982, the secretary of Health & Human Services and the head of the Food & Drug Administration hailed the United States as "the first nation to approve this important new drug." Their joint statement did not mention the acne drug's potential for teratogenicity, a warning that the FDA had required in its labeling. Nor did they, or anyone else--at least from the public record-mention or even know then of a potential link between isotretinoin and suicide.

But in the nearly two decades since isotretinoin's introduction as a treatment for ...

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