FDA Mandates Labels For Pfizer, GSK Smoker Drugs

Law360, New York (July 1, 2009, 12:00 AM EDT) -- The U.S. Food and Drug Administration has required Pfizer Inc. and GlaxoSmithKline PLC to put boxed warnings on their smoking-cessation aids amid reports linking the medications to suicides.

The FDA said Wednesday that Pfizer's Chantix, or varenicline, and GSK's Zyban, or bupropion, will now carry boxed warnings and have patient medication guides highlighting the risks of serious neuropsychiatric symptoms including hostility, agitation, depression and suicidal thoughts.

“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting...
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