Antidepressant Labeling Updated with Abuse Warning

Wellbutrin XL, Forfivo XL, Aplenzin, and related generics have been updated with the statement on abuse
Wellbutrin XL, Forfivo XL, Aplenzin, and related generics have been updated with the statement on abuse

The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for bupropion extended-release products. 

The sNDA proposes the addition of a statement regarding abuse in humans: Bupropion (HCl or HBr) extended-release tablets are intended for oral use only. The inhalation of crushed tablets or injection of dissolved bupropion has been reported. Seizures and/or cases of death have been reported when bupropion has been administered intranasally or by parenteral injection. 

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Bupropion, an aminoketone antidepressant, is indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). It is also indicated as an aid in smoking cessation (ZybanGlaxoSmithKline). Bupropion is presumed to exert its effects through noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal uptake of norepinephrine and dopamine and does not inhibit monoamine oxidase or the reuptake of serotonin. 

Drug products updated with the statement on abuse include: Wellbutrin XL (bupropion HCl extended-release; Valeant)Forfivo XL (bupropion HCl extended-release; Edgemont), Aplenzin (bupropion HBr extended-release; Valeant),  and related generic products. 

For more information call (888) 463-6332 or visit FDA.gov.

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