Chantix Label Under Scrutiny
Recently, public safety advocacy groups have begun to initiate federal correspondence regarding the potential hazards of the drug Chantix.
Chantix General Information
Chantix, produced by Pfizer Inc. and chemically known as varenicline, is a medication intended to help people stop smoking.
The drug blocks nicotine, the addictive quality of smoking, from inhibiting the brain; therefore, smokers do not feel the same relief during smoking.
According to Fox News, current labeling advises to stop use if agitation, depressed mood, suicidal thinking, or other behavioral changes occur. The labeling includes bold letter warning about possible psychiatric problems – this critical warning was added in 2009.
The Food and Drug Administration (FDA) started investigating the anti-smoking drug’s possible side effects in 2007, when it collected $883 million in sales. The drug is sold globally. Chantix has been sold since 2006.
Pfizer has been sued over Chantix’s side effects in the past. Side effects such as psychiatric problems, injuries, and even suicides have prompted over 2,500 lawsuits. The New York-based corporation has spent around $300 million in settlements.
Chantix use has been restricted by some employers, including the Federal Aviation Administration and the U.S. Department of Defense.
Chantix Labeling Reform Debate
Consumer Reports, Public Citizen, the National Center for Health Research, National Physicians Alliance, and the Institute for Safe Medication Practices have combined forces in an effort to change the labeling on Chantix.
These organizations have formally petitioned the FDA to consider having more detailed information about side effects on the anti-smoking drug’s labeling. The potential side effects being addressed include suicidal behavior, hostility, and depression. Furthermore, the labeling should include information about blackouts, convulsions and other problems, all which have been reported by patients.
The group argues that “it would be illogical to discount the reports of thousands of consumers who told of frightening or destructive experiences with Chantix.” Also, that the current labeling “substantially underestimated the psychiatric adverse effects and accident risks of Chantix.”
The argument has also been made that Chantix should not be taken by people in certain career fields: the military, policing, and airline industry.
Pfizer Inc. is attempting to take away the emphasized warnings. The corporation has released a statement claiming that the patient report based petition has “several limitations, including missing data, reporting biases, and no ability to determine that the adverse event was caused by the drug.” Studies conducted by Pfizer have shown no link between Chantix and suicidal behavior.The studies “do not show evidence of an increased risk of serious neuropsychiatric events” in Chantix users in comparison to other anti-smoking medications.
The FDA will review Chantix’s risks by looking at all the studies and speaking to Pfizer representatives, outside experts, and members of the public.