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New Warning for Isotretinoin
JAMA. 1998;279:984.
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The FDA and the manufacturer of isotretinoin (Accutane) have taken steps to strengthen the drug product's label with respect to isolated reports of depression, psychosis, and, rarely, suicidal thoughts and actions. The "Warnings" section 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 paragraph on depression in the "Adverse Reactions" section will be revised as follows:
"In the post-marketing period, a number of patients treated with Accutane have reported depression, psychosis, and, rarely, suicide ideation, suicide attempts, and suicide. Of the patients reporting depression, some reported that the depression subsided with the discontinuation of therapy and recurred with reinstitution of therapy."
As noted in a letter sent to physicians by the . . . [Full Text of this Article]
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Isotretinoin and Psychiatric Illness in Adolescents and Young Adults
Enders and Enders
The Annals of Pharmacotherapy 2003;37:1124-1127.
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