Smoking Cessation Drugs Get Boxed Warning
Evans, Jeff, Clinical Psychiatry News
Accumulating reports of serious neuropsychiatric symptoms associated with the smoking cessation medications varenicline and bupropion have prompted the Food and Drug Administration to require new boxed warnings for the drugs.
The warnings, which went into effect July 1. highlight symptoms that include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and suicide.
The manufacturers also are required to revise the plain-language medication guides that come with the drugs.
The requirements will affect the drugs that are specifically indicated for smoking cessation--Chantix (varenicline), manufactured by Pfizer Inc., and …
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Publication information: Article title: Smoking Cessation Drugs Get Boxed Warning. Contributors: Evans, Jeff - Author. Magazine title: Clinical Psychiatry News. Volume: 37. Issue: 8 Publication date: August 2009. Page number: 4. © 2009 International Medical News Group. COPYRIGHT 2009 Gale Group.
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