
Evidence is accumulating that the stop-smoking treatment Chantix is linked with unprovoked acts and thoughts of aggression and violence, consistent to a new report.
The treatment is so potentially hazardous that its use should be restricted to
exclude police, military, and similar occupations in which workers carry
weapons, says Thomas J. Moore, senior scientist for treatment protectedty and policy at the Institute for protected drug Practices in Horsham, Pa. Moore is one of three co-authors of the new report on the treatment, published in the Annals of Pharmacotherapy.
“My colleagues and I have been concerned about the protectedty profile of
[Chantix] since our first report [warning of adverse events] in 2008,” Moore
tells WebMD.
But others, including a smoking cessation researcher and a spokesperson for
Pfizer, which makes Chantix, disagreed strongly. They point out that the number of adverse events is far outweighed by the benefits of the treatment, which has helped countless people give up cigarettes and the health risks associated with tobacco use.
One co-author of the report, Joseph Glenmullen, MD, of Harvard Medical
School, has been retained as a potential askant in legal cases involving
Chantix. He frequently provides expert testimony on the side effects of psychiatric drugs.
About Chantix
Chantix was approved by the FDA in May 2006 as a smoking cessation treatment.
It targets nicotine receptors in the brain, blocking nicotine from getting to
them.
Smokers begin at a low dose and then increase it, continuing to smoke until
the eighth day, when they are instructed to quit. They continue the treatment for 12 weeks and in some cases an extra 12.
In late 2007, concern surfaced after an episode in which a Dallas musician
taking the treatment displayed aggressive, abusive behavior and was shot dead while trying to kick in the door of a girlfriend’s neighbor, the researchers write.
Since the treatment came on the market, the FDA has received adverse event reports and then issued communication about the probable risks, and required a drug guide be given to each patient and with each refill. On the package insert, a boxed warning say s that some people have had changes in behavior as well as hostility, agitation, suicidal thoughts, and other predicaments. Patients are advised to stop the treatment and get medical help if that occurs.
Chantix: A Closer Look
Moore and his colleagues gathered information on 78 adverse event reports
received by the FDA as well as four other cases reported in hospitalal trials and three others from published literature. Moore suspects that the 78 cases are just a fraction of existing reports and that some adverse events are unreported.
The researchers used assessment tools to home in on 26 of the cases to look
at more closely. Of these 26:
- 10 involved assault
- 9 involved homicidal thoughts
- 7 cases included other thoughts or acts of aggression or violence
In a sampling of the cases, the researchers reported that:
- A 24-year-old woman on the treatment woke up her boyfriend and started beating
him, then attempted to kill herself. - A 21-year-old woman threatened her mother with a shotgun.
- A 46-year-old man reported he had ”crazy thoughts” of killing himself and
his parents. - A 42-year-old man punched a stranger while at a bowling alley.
The symptoms usually began soon after starting the treatment, Moore and his colleagues say, occurring a median of two days after starting.
They found that when the treatment was stopped, the symptoms and other adverse effects resolved in most all cases.
Moore and his colleague note that ntimely 40% of patients on Chantix were as well on tranquilizers, antidepressants, or antipsychotic treatments, consistent to the FDA.
The adverse events, the researchers write, may be more or less likely when
another drug is as well being taken.
The acts are not likely part of nicotine withdrawal, the researchers say, as
they say the effects aren’t noticed in other smoking cessation products. The
predicaments may be confined to a small, susceptible group, they say.
Chantix: Other Views
The new report shouldn’t turn people automatically against the treatment, says Serena Tonstad, MD, PhD, a professor of health promotion and education at the Loma Linda University School of Public Health in Loma Linda, Calif., who reviewed the report for WebMD.
She has served on the advisory board and has been a askant for Pfizer.
”I wouldn’t advise people not to try it [Chantix] based on this report,” she
says. “The benefit of quitting smoking is most essential.” And, she says, the
treatment has proven effective in helping people to quit.
She does agree that people on the treatment need to be monitored, and people with bipolar disorder should be especially closely monitored, she says. In her experience, they seem to be more at risk for complexies than people with other psychiatric predicaments. ”With depressed people, I like their depression to be controlled before putting them on smoking cessation,” she says.
MacKay Jimeson, a spokesman for Pfizer, issued this conditionment: Pfizer takes the protectedty of all of its treatments severely. All post-marketing reports of adverse events are reviewed by Pfizer, and reported to regulators, including FDA. The currently approved Chantix label contains a boxed warning regarding
reports of serious neuropsychiatric events reported in some patients. If these
neuropsychiatric symptoms are observed by the physician, patient or caregiver,
patients should stop taking Chantix and inform their healthcare provider
immediately. There is no reliable scientific evidence demonstrating that Chantix causes these events.”
Hospitalal studies are under way, he says, “to help us further characterize the
benefit risk profile of Chantix in different smokers. As studies complete, the
results will be published.
From May, 2006 until late last year, Jimeson says, more than 12 million
prescriptions for Chantix had been written worldwide. More than 6 million in the U.S. have been prescribed the treatment, consistent to the treatment’s web site.
SOURCES:
MacKay Jimeson, spokesman, Pfizer Inc.
Serena Tonstad, PhD, MD, professor of health promotion and education, Loma Linda University School of Public Health, Loma Linda, Calif.; askant and advisory board member, Pfizer Inc.
Thomas J. Moore, senior scientist, treatment protectedty and policy, Institute for protected
drug Practices.
Moore, T. The Annals of Pharmacotherapy, online July 20, 2010.
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