Chantix Suicide and Homicide Risk: Lawsuit

Boston, MAChantix is a story that just won't go away. While critics pine for a Chantix recall that just isn't happening, and doctors become increasingly alarmed over associations between Chantix and suicide, a number of watchdog agencies continue to raise the alarm over this once-exalted anti-smoking drug that appears to be doing more harm than good for an awful lot of people.

One of the latest warnings originates with the Institute for Safe Medication Practices, which claims that over 1000 serious incidents were linked to Chantix over the first quarter of 2008 alone. It will be interesting to determine what the numbers for Chantix, which agreed to a black-box warning after being pressured by the US Food and Drug Administration (FDA) last year, will be for all of 2008.

Meanwhile, concern continues to spread around the globe over a drug that directly targets the brain, and has resulted in various adverse reactions, including heart palpitations, dizziness, seizures, and suicide ideation.

In The United Kingdom, the UK drug safety regulator, the Medicine and Healthcare Products Regulatory Agency (MHPRA), is reporting this month that after crunching the data, there had been no fewer than 3,541 reports of suspected adverse reaction to varenicline (Chantix, but known as Champix in the UK) as at September 29th.

Insomnia and the experiencing of abnormal dreams, together with nausea and vomiting have been cited alongside various psychiatric reactions that have been associated with, if not directly attributed to the smoking cessation drug. And while the MHPRA is quick to point out that nicotine withdrawal, and the simple act of attempting to give up a lifetime habit can, in isolation result in great difficulty to the patient, including depressed mood, the agency has found that suicide related events have been reported in varenicline patients with no, known pre-existing psychiatric difficulty. People who have continued to smoke have also, for that matter, reported Chantix suicide.

From Suicide, to Homicide

Yes, homicide—that's the allegation by four varenicline patients who are suing Pfizer, the world's biggest drug manufacturer and the pharmaceutical giant behind the introduction of Chantix in 2006. The four claim that Chantix drove them into depression, which in turn triggered thoughts ranging from suicide, to homicide.

The complaint, filed in St. Louis Federal Court on November 7th, asserts that Pfizer misrepresented, or hid outright from the public that Chantix could also cause side effects ranging from hallucinations and hostility, to irregular heartbeat.

"Neither the drug label, packaging insert, nor the package containing the product provided adequate warnings that using Chantix carried a risk of experiencing serious injury and/or death," the two men and two women said in their complaint.

Since Chantix was approved by the FDA in 2006, it has quickly shown its true colors. Initially considered a massive breakthrough that promised to revolutionize the smoking cessation industry, Chantix has proven to be a wolf is sheep's clothing for a growing number of Americans desperate to kick the habit.

Unlike a nicotine patch, and other more traditional smoking cessation methods, Chantix directly targets the brain, which in turn regulates the response to nicotine and the amounts of dopamine (that pleasureful feeling derived from taking a puff) released. Some have argued that given the fast-track route Chantix has to the brain, the clinical trial should have been longer, broader and more involved by including participants that more accurately mirrored the smoking community.

While it's been reported that Pfizer hand-picked clinical trial participants and weeded out people with formidable physical, or emotional baggage, smokers in general are more apt to present serious physical, as well as emotional issues that might have had a bearing on a successful Chantix outcome. However it has been alleged that such attributes, which might have given Pfizer a more accurate reading with regard to Chantix in the testing phase, were excluded from the clinical trial criteria.

Only when Chantix was embraced whole-heartedly by the smoking community in 2007, did the problems begin to appear.

"Pfizer is aware of lawsuits that make claims related to the medication Chantix," spokesman Christopher Loder told Bloomberg News. "Pfizer will vigorously fight these lawsuits as Chantix is a safe and effective option for patients trying to quit smoking."

Chantix sales worldwide fell 24 percent, to $182 million in the third quarter of this year.

While the FDA fast-tracked Chantix to market due to its promise, it is keeping the smoking cessation drug under surveillance. Many are calling for a recall of Chantix, yet it is not surprising that the FDA has yet to pull that trigger given the normal position that the benefits of a drug must outweigh the risk. While Chantix has actually driven some to suicide and has caused even more people to consider it, the fact remains that smoking kills, and there is still huge sector of the population that smokes. Perhaps given the numbers, Chantix has yet to achieve a status as bonefide risk.

In other words, smoking kills. But Chantix has allegedly killed fewer. That might make it okay in the eyes of some. But for others, Chantix suicide, or Chantix and suicide in the same sentence are grounds for nothing less than a total Chantix recall.