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Acne Drug Depression Warnings Highlight Need for Expert Care
Lynne Lamberg
JAMA contributor
JAMA. 1998;279:1057.
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DESPITE NEW label warnings of a possible association with depression, isotretinoin (Accutane) remains the drug of choice for severe, recalcitrant nodular or inflammatory acne, according to specialists in this disorder interviewed at the annual meeting of the American Academy of Dermatology in Orlando, Fla, last month.
The warnings section of Accutane prescribing information will now begin with the following paragraph in bold type:
"Psychiatric Disorders: Accutane may cause depression, psychosis and rarely, suicidal ideation, suicide attempts and suicide. Discontinuation of Accutane therapy may be insufficient; further evaluation may be necessary. No mechanism of action has been established for these events."
The label change was triggered by reports to MEDWATCH, the Food and Drug Administration (FDA) spontaneous reporting system, which aims to elicit early signals of potential problems with medications and other FDA-regulated medical products.
Although no cause-and-effect relationship has been established, the new concerns make the FDA, Hoffmann-La . . . [Full Text of this Article]
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