News Tagged ‘Adverse Event Reporting System’

FDA monitoring Chantix for serious risks, new safety concerns

no smoking 100x100Last 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 , 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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Pfizer and other drug companies fund medical courses

med school 100x100The 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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Chantix plays role in record number of drug reactions

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 ’s Adverse Event Reporting System (AERS) reveal that Heparin and Chantix are largely to blame for the upward swing.

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Researchers recommend new Chantix warnings

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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