More Data Regarding Suicide and Chantix

The Food and Drug Administration has received information about numerous serious problems with Chantix, including suicidal thoughts and ideation, homicidal ideations, and hallucinations. The FDA received reports of 37 suicides and 491 cases in which people had suicidal thoughts. If history is any guide, the actual incidences are often more than 10 times what the FDA reports. In other words, these numbers are probably just the tip of the iceberg. Still, there is no indication from Pfizer that there will be a recall of Chantix.
Pfizer released the drug without any warning regarding these potential side effects. By January of 2008, the reports of psychological side effects, most notably suicidal actions and ideations, reached a critical mass and Pfizer added a warning to the label of Chantix about the potential risks of suicidal behavior and depression. This warning followed a November 2007 update to Chantix's "post-marketing experience" section which stated that there had been reports of depression, agitation, and suicidal behavior and ideation in patients on Chantix. The FDA now says it is "increasingly likely" that there is an association between Chantix and suicidal thoughts, actual suicide, depression and other psychiatric symptoms.

Anti-Smoking Drugs Can Create Suicidal Thoughts and Aggressive Behavior

In January of this year, David Collins killed himself with a shotgun just three months after he began taking Chantix (varenicline) a smoking cessation drug made by Pfizer. Linda Collins who is David Collins widow has filed a lawsuit in Indianapolis against Pfizer over Chantix (Champix in other countries) its side effects and its possible failure to provide warnings to users. Mr. Collins had no prior history of mental illness, but before his suicide Mr. Collins exhibited aggression and strange behavior. More details will be divulged once the lawsuit progresses and apparently increases in size (chantixsuicidelawsuits.com). The FDA had reported thirty nine suicides and nearly five hundred cases of suicide behavior or thoughts of suicide from the use of Chantix. These suicide behaviors regarding Chantix are similar to the black box warnings that all drug companies are compelled to divulge on their antidepressant labels. Just two months ago, the FDA required Chantix (varenicline) and Zyban to carry a black box warning due to side effects including depression, suicidal thoughts, and suicidal actions.
Zyban made by GlaxoSmithKline involves bupropion an antidepressant drug which acts as a norepinephrine and dopamine reuptake inhibitor and nicotinic antagonist. This drug is cross marketed as an antidepressant and smoking cessation drug. To our knowledge Chantix is not cross marketed as an antidepressant. But apparently Pfizer likes to cross market drugs legally or not. This week Pfizer settled with the Department of Justice for $2.3 billion, the largest health care fraud settlement in the history of the DOJ. It resolved their criminal and civil liability arising from the illegal promotion of certain pharmaceutical products. Pfizer “off labeled” drugs for uses the FDA didn’t previously approve of. $1 billion was allocated to resolve allegations under the civil False Claims Act that Pfizer illegally promoted the drugs Bextra, Geodon an anti-psychotic drug, Zyvox, an antibiotic, and Lyrica, an anti-epileptic drug. What is worse is that Pfizer is a habitual criminal company since they have been found guilty before in a similar case.
Tony West the DOJ Assistant Attorney General for the Civil Division was quoted by news releases, “Illegal conduct and fraud by pharmaceutical companies puts the public health at risk, corrupts medical decisions by health care providers, and costs the government billions of dollars”. Perhaps this massive fine will curtail Pfizer to some degree, but they will likely need at least three strikes. We think this is the beginning of more and more lawsuits against pharmaceutical companies for cross labeling, inadequate tests and warnings, and drugs that create suicidal thoughts, and aggressive behavior. Consumers need to fully perform their due diligence before taking drugs which have clear controversial effects. Chantix and Zyban have a new warning that the drug can produce suicidal thoughts and behavior. Do you want to stop smoking or stop life?