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Kicking the nicotine habit can involve some mental and emotional stress, but it’s usually taken lightly, even humorously. No one undergoing nicotine withdrawal ever threatened to jump off a tall building or shoot passers-by. But now we find that a popular drug sold as a panacea for people who want to quit smoking can put them over the top enough to actually commit suicide or kill others.
The Drug
The chemical name of this smoking cessation drug is varenicline. It has been marketed by Pfizer internationally with two different trademark names, one for the USA and another for 45 other countries. The FDA approved Pfizer’s patent for varenicline, with the trade name Chantix in the USA and Champix outside America, in May 2006. Annual sales have reached well over a billion dollars US.
Chantix’s application as a smoking cessation drug has proven to have been overhyped while camouflaging reports of dangerous side effects. It has not been very effective for helping smokers quit. And Pfizer’s adverse effect reporting method has obscured the real figures on side effects, ignoring heart health issues as well as suicidal and homicidal behavior.
Tweaking Stats to Appear Less Dangerous
It wasn’t until the independent non-profit organization Institute for Safe Medication Practices (ISMP) discovered and tracked the misdirected serious adverse effect reports that a true picture emerged. After analyzing the data, ISMP scientist Thomas Moore noted that there was “a major breakdown in safety surveillance”.
Serious adverse effects were mixed in with the usual minor adverse effect reports of nausea, constipation, and rashes. How serious? As serious as suicide and violent attacks on others! There were almost 600 such events buried among the 26,000 less serious adverse reports since 2006. Once the buried reports were isolated, the total suicide count of those using the drug went from 122 to 272.
Moore also commented in the September 2010 issue of Journal of Pharmacotherapy that Chantix tends to unleash something in people that can cause sudden violent reactions at anytime toward self or others. His comment was based on closely analyzing 26 episodes of violence found amongst the obscurity of minor adverse events.
Additionally, there were several reported injuries from accidents, mostly automobile, which occurred during periods of fogginess, light headedness, or dizziness. Many others experienced unusual depressions while taking the smoking cessation drug.
Chantix tablets are prescribed to be taken twice a day. The side effects listed on the container are far fewer and less serious than the prescription information leaflet distributed to doctors in 2009, three years after FDA approval and after getting caught with sweeping many suicide/homicide reports under the rug.
One section warns of “Serious Neuropsychiatric Events” with the caveat that doctors should inform patients to report to them if they are experiencing extreme depression or thinking seriously of suicide or murder.
There are over 1500 injury cases against Pfizer pending in Federal Court, including one where the parents of a murder/suicide married couple are suing. The plaintiffs claim that Pfizer knew of the extreme adverse effects since 2006 and camouflaged those statistics with their shady reporting procedures.
This grim reality did not surface until 2009 when the ISMP discovered many more adverse effects woven into the blur of thousands of minor reports. Normally, adverse reaction reports are supposed to be categorized and conspicuously isolate serious side effects from minor ones.
FDA Protects Big Pharma While Attacking Natural Health Product Providers
The black box warning of potential suicide is the most serious mark against any drug. However despite admitting off the record that the side effects of Chantix are worse than expected compared to Pfizer’s original trial study reports, the FDA is standing on its original approval.
In 2010, over 3 million people have been prescribed two tablets daily of Pfizer’s smoking cessation drug for 12 weeks. Probably the best advice is to shun the drug if you are a smoker who intends to quit, and stay away from any ticking time bomb who insists on using Chantix or Champix.
The latest FDA shrug, standing firm on its approval of Chantix, is from the same agency that continues to raid and harass herbal and supplement providers for promoting safe and effective products. And think about the many suicides and homicides by those on psychotropic drugs that are still being marketed and prescribed by psychiatrists and MDs.
The FDA is Big Pharma’s protector, and it doesn’t care about our safety.
Sources for this article include:
http://healthmaven.blogspot.com/2011/05/smoking-pill-suicides-overlooked-in.html
http://whyquit.com/pr/082506.html
http://labeling.pfizer.com/ShowLabeling.aspx?id=557
