There are numerous products on the market to help quit smoking including everything from “The Patch” to chewing gum. One such product is Chantix, a non-nicotine prescription medicine to help adults quit smoking by reducing the urge to smoke. Released by Pfizer, Chantix has come under recent heat from several industries banning the drug as unsafe for its workers. The Institute for Safe Medication Practices’ (ISMP) report on the adverse effects of Chantix has created a wave of questions from the Food and Drug Administration (FDA), Senator Chuck Grassley, the Federal Motor Carrier Safety Administration (FMCSA), and the Federal Aviation Administration (FAA).
ISMP’s study, authored in part by Thomas Moore, found shocking numbers regarding Chantix’s possible side effects. Between Chantix’s May 2006 approval and the end of December 2007, the ISMP found the following were reported to the FDA:
- 227 Domestic reports of suicidal acts, thoughts or behaviours
- 397 Cases of possible psychosis
- 525 Reports of hostility or aggression with many reporting hallucinations and thoughts of killing people
- 28 suicides
The ISMP’s study sparked a chain reaction of responses from two key industries: the FAA and the FMCSA. On May 22, 2008, the FAA banned usage by air traffic controllers and pilots. The Washington Post reported the FMCSA issued a warning May 23, 2008 against issuing commercial licenses to those who take Chantix.
Today, the FDA’s Janet Woodcock, head of FDA Center for Drug Evaluation and Research, will meet with health staffers from Senator Grassley’s office to determine the extent of the FDA’s knowledge about Chantix and its effects. Though the FDA issued a warning regarding Chantix in February, it has yet to act in response to these recent developments.
Although Pfizer plans to launch a campaign asserting Chantix’s effectiveness, it nevertheless maintains, “[T]he current Chantix label accurately reflects the product’s efficacy and safety profile.” Pfizer offers resources to consumers in conjunction with Chantix, including its “Get Quit Support Plan.”
However, it seems Pfizer has more questions to answer that public relations campaigns and “support plans” cannot address.
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