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It looks like there is another ominous blip in the Chantix radar. Pfizer decided to ditch the ad agency it has been using for its Chantix advertisements. The announcement comes after the company announced the smoking cessation drug’s fourth quarter earnings, which fell 36 percent from the same time last year to $180 million.
Health Canada has received 818 reports of adverse side effects caused by the smoking cessation drug Chantix (marketed in Canada and elsewhere as Champix) since it first became available to Canadians nearly two years ago. The majority of complaints concerned psychiatric problems. Chantix is known to cause or exacerbate a spectrum of psychiatric and physical reactions, including moodiness, depression, violent behavior, lack of sleep, blackouts, and suicidal thought and actions.
A group of scientists at the Food and Drug Administration has sent a letter to President-elect Obama and his transition team, urging a clean-up of the government agency. The letter says that widespread mismanagement and incompetence in the agency have “placed the American public at risk.”
The Canadian Press reports that Health Canada, the government department responsible for Canada’s public health policies, is currently working with Pfizer to strengthen the warnings for the smoking cessation drug Chantix. Chantix is sold in Canada and elsewhere overseas under the name Champix.
In September, we learned that those long Chantix ads featuring the tortoise and the hare were reappearing on TV after Pfizer yanked them from the airwaves for several months. The drug maker pulled the ads when it became evident that a link existed between Chantix, depression, and suicide. Unfortunately, the new ads were even longer than the original by 30 seconds — for a total of 90 seconds — to accommodate all the new warnings.
According to The Institute for Safe Medicine Practices (ISMP), the number of drug-related adverse events and deaths reported to the Food and Drug Administration has hit a record level. Numbers pulled from the FDA’s Adverse Event Reporting System (AERS) reveal that Heparin and Chantix are largely to blame for the upward swing.
Researchers at the Institute for Safe Medicine Practices, a nonprofit organization, and Wake Forest University say that their latest review of Chantix data justifies stepping up warnings about the drug.
More than 1,000 complications were reported in the first quarter of 2008, including 15 traffic accidents, 52 incidents of loss of consciousness and blackouts, and 50 deaths.
Reports of adverse effects among users taking Chantix were greater than any other prescription drug for the second quarter in a row.
Yesterday I wrote about the non-psychiatric side effects of Chantix and how studies are beginning to reveal how those side effects can adversely affect one’s driving. Loss of consciousness, dizziness, confusion, aggression, and muscle spasms can all happen to a Chantix user who is behind the wheel. I don’t mean to sound alarmist, but I have had enough first-hand experience with Chantix to know these newest warnings are worth emphasizing.
By now we know that Chantix is dangerous for some people who use the drug, but mounting evidence suggests that people who don’t use it may also be harmed. Since Chantix became available for smoking cessation in August of 2006, the FDA has received a steady influx of reports connecting the drug to traffic accidents. Moreover, while the medical community and the media are focused on the negative psychiatric effects that some Chantix users experience, researchers now believe that the non-psychiatric effects may be worse.
Many medical researchers find little surprise that Chantix has been linked to higher than normal rates of depression and suicide. Varenicline (the chemical name of Pfizer’s smoking cessation drug) goes to work directly in the brain by targeting certain receptors and simulating that feeling of having already smoked – that “full” feeling smokers feel after they’ve lit up one or two. Other pharmaceuticals that go to work directly in the brain include antidepressants, some of which have also been linked to behavioral problems and suicide.
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