Rexulti Warnings For Compulsive Behavior And Impulse Control Problems Added To Drug Label

FDA: Patients Using Rexulti At Risk For Experiencing Intense Urges For Gambling And Inability To Control Conduct   (Posted by Tom Lamb at DrugInjuryWatch.com)   Rexulti® (brexpiprazole) was initially approved by the FDA in 2015 for the adjunctive treatment of major depressive disorder (MDD) and the treatment of schizophrenia. As shown in a February 9, 2018 FDA letter to Otsuka Pharmaceutical Company, Ltd., the agency approved some label changes for Rexulti for the addition of warnings about pathological gambling and other compulsive behaviors: Please refer to your Supplemental New Drug Application (sNDA) dated and received June 23, 2017…. This Prior Approval supplemental new drug application provides for a new subsection under the Warnings and Precautions section entitled Pathological Gambling and Other Compulsive Behaviors and corollary revisions to the Highlights, Adverse Reactions, Patient Counseling Information, and Medication Guide. And from the FULL…

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