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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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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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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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.

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Responding to widespread pressure from many congressmen, veteran’s organizations, and the general public, the Veterans Administration announced today that it would directly notify all of its veterans currently using Pfizer’s new smoking cessation drug Chantix. The number of veterans on Chantix is approximately 32,000.

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According to an article published by Bloomberg news service, a recent review of voluntary adverse event reports associated with Pfizer’s stop-smoking drug Chantix reveals more than 3,000 reports of serious side effects in the U.S. alone. Among problems cited by the nonprofit Institute for Safe Medication Practices, which conducted the study, are suicide, heart trouble and aggression.

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