Study Links Chantix to Aggressive Behavior, Violence

Evidence continues to mount against the stop-smoking drug <"">Chantix and its links to aggressive behavior and violence, said WebMD, citing an emerging report.

As a matter-of-fact, wrote WebMD, Thomas J. Moore, senior scientist for drug safety and policy at the Institute for Safe Medication Practices in Horsham, Pennsylvania said that Chantix has so much potential danger it should contain restrictions including exclusions for police, military, and others who must carry weapons. Moore is one of three others who co-wrote the new Chantix report just published in the journal, Annals of Pharmacotherapy, said WebMD.

“My colleagues and I have been concerned about the safety profile of [Chantix] since our first report [warning of adverse events] in 2008,” Moore told WebMD.

We recently wrote that strong warnings were issued by Health Canada over Champix (in the U.S., the drug, generically known as varenicline tartrate, is called Chantix), which is sold by Pfizer Canada Inc., wrote The Globe and Mail. The warning was issued by Pfizer and federal health officials following concerns that the drug is linked to “mood changes; hostility; suicidal behavior and serious, sometimes fatal, skin reactions.” Champix, the Pfizer Canada, Inc. brand must carry a boxed warning, indicating a serious safety issue or serious issue with adverse events exists, said The Globe and Mail; the U.S. Food and Drug Administration (FDA) had earlier required a similar warning.

Approved in the U.S. by the FDA in 2006 as a treatment for smoking cessation, wrote WebMD, Chantix blocks nicotine by targeting the brain’s nicotine receptors. Treatment begins with a low dose that is incrementally increased while smokers can smoke into their eighth day, at which point, they must cease smoking, explained WebMD. Patients remain on the drug for 12 weeks and, sometimes, can be prescribed an additional 12 weeks of the drug.

About a year after being on the market, reports began emerging about patients exhibiting strange and dangerous behavior while on Chantix. For instance, a Dallas musician on Chantix was behaving aggressively and abusively and was killed while attempting to kick in the door of a girlfriend’s neighbor, the researchers wrote, said WebMD. The FDA has received a number of other adverse event reports and issued information on the potential risks, mandating a medication guide be provided to patients with each refill, wrote WebMD.

The authors of this recent study collected data on 78 adverse event reports received by the FDA, four cases reported in clinical trials, and three cases from published information, said WebMD. According to Moore, the 78 cases are just a drop in the bucket. Looking at 26 cases in particular, the authors found that “10 involved assault, nine involved homicidal thoughts, and seven … included other thoughts or acts of aggression or violence,” said WebMD.

In another sampling review, the authors found that at least four people expressed seriously aggressive behavior against themselves, loved ones, and strangers with symptoms tending to appear about two days after starting Chantix, said WebMD. Once stopped, the symptoms—for the most part—disappeared.

Previously, the FDA said psychiatric side effects seen among Chantix users included 98 reports of suicide and 188 reports of attempted suicide. While some reported psychiatric problems could have been the result of nicotine withdrawal, the FDA noted that many problems occurred while Chantix users were still smoking. Also, as of recent data, Health Canada received over 1,200 reports of adverse reactions associated with Champix since its release in country in 2007, said The Globe and Mail.

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