Researchers believe FDA should increase warnings on stop smoking drug
Back in July published in the Canadian Medical Association Journal were findings of a study which had shown the stop smoking medication Chantix from Pfizer greatly increase cardiovascular events. Now researcher’s state Chantix increases suicidal behavior and depression by eight time’s greater risk.
Researcher’s from Wake Forest Medical Center study goes firmly against the FDA’s two studies on the drug. The FDA had shown Chantix did not raise the risk for hospitalization of psychiatric problems like depression. This new research however, does demonstrate that this stop smoking drug is associated to an eight times greater risk for suicidal behavior or depression in comparison to other smoking cession products such as the patch.
Since 2007, the long running argument of Chantix has been heating up with health experts since that time questioning this drugs long term safety effects in relation to vision lapses and cardiovascular events which prompted the FDA around June of this year to issue a notice citing that Chantix could be linked with a small increase of heart attacks and other cardiovascular events.
As far as the previous studies from the FDA, the agency did acknowledge the studies had flaws due to the fact they were too small to identify rare events and only documented cases which had the severity to put people in the hospital.
Chantix seems to following the same incidence rate as Zyban in which the FDA in 2009 had issued a “black box” warning label on Zyban and Chantix warning physicians and patients of the risk for depression, suicidal thoughts and hostility.
Dr. Curt Furberg, professor of health at Wake Forest and co-author of this study that is published online in the Public Library of Science journal PLoS One in a statement commented that the studies by the FDA had been flawed due to they could not catch most of the serious side effects such as suicide, depression and assaults. Noting these are disastrous events that may not result in hospitalization.
The new study based on adverse events from the FDA’s Adverse Event Reporting System from 1998 to September 2010. Researchers examined 3.249 reports of depression or serious self-injury associated to Chantix or Zyban from GlaxoSmithKline, approved for smoking cessation.
Among the cases 90% adverse events reported to the FDA were suicidal behavior or depression associated to Chantix regardless of the fact the drug had approval for only four of the thirteen years of information included within the study.
In comparison 229 cases of suicidal behavior or depression was linked to Zyban and 95 cases to nicotine replacement products.
Dr. Furberg stated Chantix was found to be linked with more suicidal behavior or depression reported more than any other smoking cessation drug on the U.S. market.
Dr. Furberg notes the risks do not outweigh the benefits. This is the second time Dr. Furberg has made that statement.
Pfizer once again is defending their drug as they did back in July of this year when attention was place on their drug for increase cardiovascular events. Pfizer comments the examination of the drug relies on reports of serious events reported to the FDA.
Pfizer also regards this study as a post-marketing reports and ‘does not establish a cause and effect relationship between a medicine and reported adverse event”.
Past studies from Dr. Furberg and associates have demonstrated that Chantix does raise the risk for cardiovascular problems, unprovoked aggression and sudden blackouts.
Quitting is not that easy on the other hand. According to the Department of Health and Human Services, 36% of smokers in the nation attempt to quit. Unfortunately, only three percent succeed and that is only for six months or more.
Dr. Furberg remarks the benefit of Chantix is slim and one year after people take the drug, only 10% have stopped smoking.
Dr. Furberg and associates want the FDA carry stronger warning labels and make it a second choice when other treatments have failed.
One alternative which will not give side effects is hypnotherapy that carries a 66% rate of success based on a four stage protocol.
Make sure you choose a licensed psychologist or a certified hypnotherapist. Most hypnotherapies’ will tell you it takes longer than just one session to stop smoking.
Hypnotherapy is recognized by the American Medical Association as a valid therapy.
Hypnotherapists in or around Detroit
A & L Chiropractic Center (hypnotherapist on staff)
24281 Middlebelt Road
Farmington Hills
248-477-3977
15403 Baylis Street
Detroit
313-397-1464
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