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FDAnews Drug Daily Bulletin

New Compulsion Disclaimers Added to Antipsychotic Labels

May 11, 2016

The FDA is adding warnings to the label for a popular antipsychotic after receiving reports of patients exhibiting uncontrollable compulsions toward gambling, shopping, binge eating and sexual activity.

Last week’s warning for patients taking aripiprazole — which is branded as Abilify, Abilify Maintena and Aristada — notes that these urges reportedly ceased when the medicine was discontinued or the dose lowered.

To address these concerns, the FDA is adding warnings for these effects to the labels for all affected products, as well as their patient medication guides.

 

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