Black Triangle Warning Dropped From Pfizer's Smoking Cessation Drug Label
Europe has removed its black triangle warning from the label of Pfizer Inc.'s smoking cessation drug Champix (varenicline; known as Chantix in the US) on the back of new long-term use data.
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The US FDA has ordered Pfizer and GlaxoSmithKline to add "black box" label warnings about serious neuropsychiatric effects for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion). The companies also must conduct postmarketing clinical trials to determine the incidence of serious neuropsychiatric symptoms, including depression and suicidality, in patients taking the therapies.
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