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Chantix has to be one of the most bipolar prescription drugs ever created. Every day, a search for the latest Chantix news digs up blogs written by fans of the smoking cessation drug, who often tout it as a miracle or a blessing in their struggle to become nonsmokers. Yet other users liken it to a nightmare or a curse, citing wild mood swings, disturbing dreams, and uncharacteristic thoughts of suicide.
Many medical researchers find little surprise that Chantix has been linked to higher than normal rates of depression and suicide. Varenicline (the chemical name of Pfizer’s smoking cessation drug) goes to work directly in the brain by targeting certain receptors and simulating that feeling of having already smoked – that “full” feeling smokers feel after they’ve lit up one or two. Other pharmaceuticals that go to work directly in the brain include antidepressants, some of which have also been linked to behavioral problems and suicide.
According to a report in today’s Stars & Stripes, a daily newspaper published for the U.S. military, Department of Defense (DoD) civilians, contractors and their families, the anti-smoking medication Chantix (varenicline) has been pulled from at least one military pharmacy following reports of serious adverse reactions.
Chantix, like every drug on the market today, has side effects. You must consider all the facts in order to make an informed decision. Only after careful consideration and discussion with your doctor will you be able to determine if the potential benefit outweighs the risks.
The FDA recently announced that “it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.” The FDA report also stated that product label warnings need to note that Chantix shouldn’t be used while driving, piloting airplanes or operating machinery because it may cause unconsciousness, seizures and hallucinations. Because of this, the FAA has banned Chantix from use by pilots and air traffic controllers.
The FDA received more accounts of serious side effects tied to Chantix in the fourth quarter of 2007 than from any other drug.
On February 1, 2008, the FDA issued an Alert to clarify its findings, noting that “it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.” The FDA report said product label warnings need to note the medication shouldn’t be used while driving, piloting airplanes or operating machinery because it may cause unconsciousness, seizures and hallucinations.
Among the psychological side effects reported to the FDA were 525 reports of hostility or aggression, 397 cases of possible psychosis, 224 reports of heart trouble, 41 cases of homicidal thinking and 28 suicides. There were also 173 serious injuries, including traffic accidents often associated with unconsciousness, dizziness, muscle spasms, or mental confusion, as well as reports of severe skin conditions in patients.
In May 2008 the Institute for Safe Medication Practices issued a report detailing Chantix adverse event reports to the FDA. The study specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of traffic accidents and falls linked to Chantix.
If your loved one has suffered a serious injury or death as a result of a side effect of Chantix, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering. Please contact our Chantix lawyers today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost, no-obligation legal evaluation of your case.
The FDA Approves New Drug for Smoking Cessation
FDA Consumer magazine | July-August 2006
In May 2006, the Food and Drug Administration approved Chantix (varenicline tartrate) tablets to help cigarette smokers ages 18 and older stop smoking. The drug received a priority review because of its significant potential benefit to public health. Chantix was reviewed in six months rather than the regular review time of 10 months, says Curt Rosebrough, M.D., M.P.H., deputy director of the FDA’s Office of Drug Evaluation II.
Early Communication About an Ongoing Safety Review
FDA Alert | November 20, 2007
FDA has received reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken Chantix, a smoking cessation product. The manufacturer of Chantix, Pfizer, Inc., recently submitted to FDA postmarketing cases describing suicidal ideation and occasional suicidal behavior. FDA currently is reviewing these cases, along with a number of recent reports in the popular press and internet sites.
Pfizer Statement on Chantix (varenicline) Labeling Update in the United States
Pfizer Press Release | January 18, 2008
Based upon post-marketing reports first reflected in a November 2007 labeling update, Pfizer today updated the Chantix label in the U.S. to include a warning that patients who are attempting to quit smoking with Chantix should be observed for serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.
FDA Issues Public Health Advisory on Chantix
FDA News | February 1, 2008
The U.S. Food and Drug Administration (FDA) today issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking. On Nov. 20, 2007, FDA issued an Early Communication to the public and health care providers that the agency was evaluating postmarketing adverse event reports on Chatix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.
Strong Safety Signal Seen for New Chantix Risks
The Instutitute for Safe Medication Practices | May 21, 2008
A strong signal of multiple safety problems with Chantix (varenicline), a drug to help people stop smoking, has been seen in a pilot program to identify new drug risks in adverse drug events reported to the U.S. Food and Drug Administration. Varenicline is suspected in various adverse drug event reports of causing a wide spectrum of injuries, including serious accidents and falls, potentially lethal cardiac rhythm distrubances, severe skin reactions, acute myocardial infarction, seizures, diabetes, psychosis, aggression and suicide.
FAA - Anti-Smoking Medicine Chantix Banned
Federal Aviation Administration news release | May 23, 2008
Less than 48 hours after FAA learned the anti-smoking medicine Chantix might lead to safety problems, it ordered pilots and air traffic controllers to stop taking it immediately. The agency took this swift action after a medical safety group, the Institute for Safe Medicine Practices, released the results of a study this week that found evidence for the occurence of seizures, loss of consciousness, heart attacks, vision problems, and various psychiatric instabilities in individuals who use Chantix.
Chantix official full prescribing information
Pfizer official Chantix web site | currently
Official Chantix full prescribing information provided by Pfizer on Chantix web site.
FDA MedWatch reporting form
FDA MedWatch | currently
If you have had an adverse reaction to Chantix or any other prescription medication, the FDA asks you to submit a voluntary report through its FDA Safety Information and Adverse Event Reporting Program. Use this form for voluntary reporting of adverse events, product problems and product use errors.
If your loved one has suffered a serious injury or death as a result of a side effect of Chantix, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.
Please contact our Chantix lawyers today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost, no-obligation legal evaluation of your case.
George J. Lisicki, a Vietnam combat veteran and national commander for the Veterans of Foreign Wars (VFW), had harsh words for the Veterans Administration (VA) today.
“Those in the VA who failed to properly notify America’s veterans that their medication could produce fatal side effects must resign their positions,” Lisicki said. “If not, then the VA secretary must take decisive action to terminate their employment.”
A man who disrupted a Thanksgiving Day flight and forced an emergency landing has been let off the hook for federal charges after a judge determined the man was emotionally disturbed as a result of taking the stop-smoking drug Chantix, according to an Associated Press report. The man, Andrew James Smith, 25, of California, was prescribed the drug a few weeks before the flight.
Once hailed as a miracle drug for helping people to stop smoking, Pfizer’s Chantix has recently raised concerns as reports surface that it may have a disturbing side effect - suicidal thoughts and actions. A report in the New Jersey Star-Ledger notes that the FDA is investigating reports of a number of serious psychological side effects. In additon to suicidal actions, reports include agitation and depression.
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