The U. S Food and Drug Administration announced that it is currently evaluating postmarketing adverse event reports for Chantix (varenicline), a prescription drug that aides adults to stop smoking.
Pfizer Inc recently submitted reports, based on the FDA's request, describing suicidal thoughts. Also being evaluated is reports of erratic and aggressive behavior.
The FDA stressed the warning "does not mean that FDA has concluded that there is a causal relationship between the drug and the emerging safety issue."
FDA recommends the following:
- Healthcare professionals should monitor patients taking Chantix for behavior and mood changes.
- Patients taking Chantix should contact their doctors if they experience behavior or mood changes.
- Patients should use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.
The purpose of a FDA early communication is to inform the public about ongoing safety reviews of drugs. After complete analysis of all information, the FDA will then issue a report containing its conclusions.
[Source: Reuters]
» Chantix Early Communication Become FDA Warning from PharmaGazette
In November the U.S. Food and Drug Administration issued an Early Communication warning that Pfizer's anti-smoking drug Chantrix may be associated with increased suicidal thoughts and aggressive behavior.On Friday the FDA issued a Public Health Adv... [Read More]
Tracked on: February 4, 2008 3:07 PM | Permalink to Trackback