Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Last week, the Food and Drug Administration released a list of about 20 pharmaceutical drugs that the agency’s researchers are closely monitoring for potential safety concerns. Not surprisingly, Chantix (Varenicline) claimed a spot on the list. According to the FDA, the drug is being watched to determine whether it causes or contributes to angiodema (rapid and potentially life-threatening swelling of skin and tissue), other serious skin reactions, visual impairment, and accidental injury.

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CNN reports that Pfizer is thinking about launching a clinical test to determine if Chantix can help prevent smokers from having heart attacks. Considering all the negative publicity that has surrounded the drug over the last one and a half years, it’s understandable that Pfizer would want to invest a good deal of time and money in finding some benefit … even if they locate just one slightly dubious side effect, such as a reduced risk of heart attack in people who have quit smoking.

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The Milwaukee Journal Sentinel recently published a comprehensive report that exposes a very questionable relationship between the University of Wisconsin-Madison college of medicine and the drug industry. Using the University of Wisconsin-Madison as an example, the report describes how pharmaceutical companies have infiltrated the nation’s universities by funding physician education courses. Critics argue that the arrangement is unethical; when a college accepts hundreds of thousands or even millions of dollars in funds for such classes, the patrons expect something back. So what might appear superficially as a philanthropic gesture is actually an arrangement with lots of strings attached — an arrangement, critics say, that amounts to huge conflicts of interest.

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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.

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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.

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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.”

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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.

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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.

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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.

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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.

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