The following documents outline the trouble facing Pfizer’s Chantix
- 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 post marketing 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.
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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.
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