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Researchers Focus on 26 Reports of Chantix as well as Aggression or Violence;
Drugmaker Says No Cause-Effect Evidence Exists
By Kathleen Doheny
WebMD Health News
Reviewed by Louise Chang, MD
July 27, 2010 — Evidence is accumulating that the stop-smoking drug
Chantix
is linked with unprovoked acts as well as thoughts of aggression as well as violence,
according to a recent report.
The drug is so potentially dangerous that its take should be restricted to
exclude police, soldierlike, as well as similar occupations in which workers carry
weapons, says Thomas J. Moore, senior scientist for drug safety as well as policy at
the Institute for Protected Medication Practices in Horsham, Pa. Moore is one of
three co-authors of the recent report on the drug, published in the Annals of
Pharmacotherapy.
"My colleagues as well as I possess been concerned about the safety profile of
[Chantix] since our earliest report [warning of adverse events] in 2008," Moore
tells WebMD.
But others, including a smoking cessation researcher as well as 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 drug, which has
helped countless people give up cigarettes as well as the health risks associated with
tobacco take.
One co-author of the report, Joseph Glenmullen, MD, of Harvard Health examination
School, has been retained as a potential consultant in legal cases involving
Chantix. He often provides expert testimony on the side effects of psychiatric
medications.
Slideshow: 13 Best Quit-Smoking Tips Ever
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 abridged dose as well as then increase it, continuing to smoke until
the eighth day, when they are instructed to quit. They continue the drug for 12
weeks as well as in some cases an additional 12.
In unhurried 2007, concern surfaced after an episode in which a Dallas musician
taking the drug displayed aggressive, abusive behavior as well as was shot not alive while
trying to kick in the door of a girlfriend’s neighbor, the researchers write.
Since the drug came on the market, the FDA has received adverse event reports
and then issued communication about the likely risks, as well as required a
medication guide be given to each patient as well as with each refill. On the package
insert, a boxed warning says that some people possess had changes in behavior as
well as hostility, agitation, suicidal thoughts, as well as other problems. Patients
are advised to halt the drug as well as get health examination help incase that happens.
Chantix: A Closer Look
Moore as well as his colleagues gathered information on 78 adverse event reports
received by the FDA as well as four other cases reported in clinical trials as well as
three others from published literature. Moore suspects that the 78 cases are
just a fraction of existing reports as well as 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 drug woke up her boyfriend as well as 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 as well as
his parents.
- A 42-year-old man punched a stranger while at a bowling alley.
The symptoms typically began soon after starting the drug, Moore as well as his
colleagues say, occurring a median of two days after starting.
They found that when the drug was stopped, the symptoms as well as other adverse
effects resolved in most all cases.
Moore as well as his colleague note that nearly 40% of patients on Chantix were as well as
on tranquilizers, antidepressants, or antipsychotic drugs, according to the FDA.
The adverse events, the researchers write, may be more or less likely when
another medication is as well as being used.
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
problems may be confined to a tiny, susceptible group, they say.
Chantix: Other Views
The recent report shouldn’t turn people automatically against the drug, says
Serena Tonstad, MD, PhD, a professor of health promotion as well as education at the
Loma Linda University School of Community Health in Loma Linda, Calif., who
reviewed the report for WebMD.
She has served on the advisory board as well as has been a consultant 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 substantial.” As well as, she says, the
drug has proven effective in helping people to quit.
She does agree that people on the drug need to be monitored, as well as people with
bipolar disorder should be especially closely monitored, she says. In her
experience, they seem to be more at risk for difficulties than people with other
psychiatric problems. ”With depressed people, I similar their depression to be
controlled before putting them on smoking cessation," she says.
MacKay Jimeson, a spokesman for Pfizer, issued this statement:
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