FDA Concerns On The Use Of Anti-smoking Aid Chantix

FDA Concerns On The Use Of Anti-smoking Aid Chantix

According to legal news site law360, the US Food and Drug Administration (FDA) has been sharing some worries about a study that looked at the adverse effects for users of smoking cessation medication Chantix.

Flaws in study data

The study in question was a clinical trial that examined the psychological risks posed by both Chantix and a similar drug, Zyban. The FDA pointed out that suicidal behaviour or ideation had not been consistently coded in the study and that descriptions such as “agitation” were not used evenly in connection with a number of different symptoms.

Chantix black box warning

The FDA wants to use data from the study to make a decision on its black box warning in connection with Chantix. In March 2015, the FDA warned that the drug might interact with alcohol, either by making users less tolerant than usual to alcohol or by encouraging aggressive or unusual behaviour. For example, some people who drank alcohol while taking the drug had no memory afterward of what had happened during the time they were under the influence of the alcohol.

The FDA also warned that the drug appeared to be connected to an increased incidence of seizures. Pfizer, the drug’s manufacturer, has settled a number of legal actions in which it was claimed that the manufacturer should have been aware that Chantix was possibly linked to suicidal behaviour and depression.

The company has been requesting that the FDA lift the black box warning on adverse psychiatric effects. The FDA only uses black box warnings for the most severe adverse reactions and rarely removes them afterward, although they have been known to modify them if they receive updated information.

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