Chantix® FDA Black Box Warning

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A number of consumer complaints about mental and behavioral side effects of Chantix® have led the FDA to require a black box warning be placed on the medication, alerting users that the drug may cause suicidal tendencies.

What’s the problem?

The FDA first indicated that they were reviewing the side effects of Chantix in November 2007. In response, Pfizer updated the drug’s label, but provided vague and confusing indications about a connection between Chantix and suicide, suicidal thoughts, and other changes in behavior. Since that time the drug maker has made several other updates to the warning label, but the FDA make it clear that Pfizer has not done enough to protect the public from the dangers of Chantix.

Due to the confirmed risks and side effects associated with Chantix, the FDA has required the drug manufactures to include a Black Box Warning on Chantix’s prescribing information. The FDA-required Chantix boxed warning includes the potential risks of serious neuropsychiatric symptoms and mental health events, including:

  • Changes in behavior
  • Depression
  • Hostility, agitation
  • Suicidal thoughts & behavior

In addition to the warning, Pfizer is required to conduct clinical trials to provide more data on how often the neuropsychiatric symptoms occur and under what conditions. Pfizer was also ordered to add more information in the medication guide that discusses the risks of the potential behavioral and mental changes, so that patients are aware to immediately contact their doctor if they notice any behavioral changes.

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