Mere days before a Food and Drug Administration (FDA) advisory committee reviews new clinical data to decide whether to recommend removing the black box warning on Pfizer’s smoking cessation drug Chantix regarding psychological side effects such as agitation, depression and suicidal thinking, the FDA is questioning whether Pfizer adequately captured the number of adverse events, biasing the research in favor of the drug. The clinical trial data was requested by the FDA after a high rate of suicidal thoughts and suicides were linked to Chantix. The trials also included GlaxoSmithKline’s anti-smoking drug Zyban, and pitted both against a placebo. In ... Read More
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