FDA Keeps Suicide Warning on Chantix Packaging
The Food and Drug Administration (FDA) declared that it is maintaining the warning associated with the consumption of anti-smoking drug Chantix. A recent study concluded that the intake of Chantix can lead to neuropsychiatric issues that can often result in either seizures or the development of suicidal tendencies.
About the Advisory Committee Decision
According to the Daily Mail, the warning label on the back side of the drug’s packaging came as a result of advice given by the advisory committee.
The committee unanimously made the decision last October. Out of the eighteen participants of the advisory committee, eleven voted in favor of keeping the black box caution the way it is, while six voted towards using some other form of warning as opposed to the existing one.
Only one member voted towards abiding by the company's request and remove the warning completely. On Monday, the FDA brought to light the latest warning associated with Chantix. People who consume alcohol while taking the drug become prone to aggressive behavior and frequent black-outs.
FDA Refuses Request to Remove Warning
- Pfizer Inc. has appealed to the removal of the warning label of its drug, but the FDA rejected their request.
- They did agree, however, to revisit it at a later date after the company provides them with the results of a study that is being conducted and which will reach a conclusion by the end of 2015.
- The ongoing study to assess the safety of Chantix includes more than 8,000 people.