We’ve all seen the Stop Smoking Campaign Ads that are plastered everywhere, encouraging people to kick the nasty habit. And, there are so many available products currently on the market to help you quit, such as; gum, patches, and both prescription and over the counter medications.
But, are the side effects of these medications or smoking cessation drugs worth the side effects that they are causing? This is the topic of a current debate fueling between a recent group of researchers, the FDA and Pfizer, the maker of one such drug.
According to one study, one of the most common medications to help people kick the habit carries too many risks and should only be tried when other treatments fail, researchers have recently said. The drug is called Chantix. And, it has now been reported that it was eight times more likely to be linked with a reported case of suicidal behavior or depression than other nicotine replacement products, such as the nicotine patch, they said.
The FDA approved Chantix in the United States in 2006 as a treatment for smoking cessation. Chantix blocks nicotine by targeting the brain’s nicotine receptors. About a year after being on the market, reports began emerging about patients exhibiting strange and dangerous behavior while on Chantix. In 2009, the FDA announced that a black box warning would be added to the Chantix label.
This new study, which appears in the Nov. 2 edition of the journal PLoS ONE, was conducted by a team of researchers from Wake Forest Baptist Medical Center, the Institute for Safe Medication Practices, Harvard Medical School and Johns Hopkins University School of Medicine.
The new study relies on adverse events from the FDA’s Adverse Event Reporting System from 1998 through September 2010. They analyzed 3,249 reports of serious self-injury or depression linked to Chantix (varenicline), GlaxoSmithKline’s Zyban (bupropion) antidepressant that was approved for smoking cessation and nicotine replacement products.
They found that 2,925 cases, or 90 percent, of suicidal behavior or depression reported to the FDA were related to Chantix, even though the drug was only approved for four of the nearly 13 years of data included in the study.
By comparison, there were 229 cases of suicidal behavior or depression related to bupropion and 95 cases related to nicotine replacement products.
“We found that Chantix is associated with more suicidal behavior reports than any other smoking-cessation drug on the U.S. market. The risks simply outweigh the benefits,” Furberg said.
“Our study contradicts the implications of a recent review by the FDA showing no difference in psychiatric hospitalizations between varenicline and nicotine replacement patches,” study co-author Curt D. Furberg, M.D., Ph.D., said in a press release from Wake Forest Baptist. “The FDA hospitalization studies were flawed because they could not capture most of the serious psychiatric side effects, including suicide, depression, aggression and assaults. These can be catastrophic events but do not normally result in hospitalization.”
“We strongly recommend that the FDA should revise the ‘black box warning’ to say what this study and the FDA’s own data show — that varenicline has higher risks for suicidal behavior and depression than other smoking-cessation treatments,” Furberg said.
Of course, Pfizer defended its drug, saying in a statement the analysis relies on reports of serious events to the FDA. These reports come from a range of sources and often lack important medical information, making them unsuitable for studies such as this, the company said.
“These same authors persist in publishing analyses based on a review of spontaneous reports,” Pfizer said in a statement. “It is important to remember that post-marketing reports do not establish a cause and effect relationship between a medicine and a reported adverse event.”
Although as stated, Chantix already carries strong warnings about side effects on its label, but Furberg and colleagues want the FDA to further restrict its use by making it a second-choice drug when other treatments have failed.
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