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October 29, 2008

Reports of Serious Drug Reactions Increase

In the first three months of 2008 the number of serious drug reactions and deaths reported to the U.S. Food and Drug Administration set a new record high according to the health industry watchdog group the Institute for Safe Medication Practices (ISMP). The FDA received 20,745 reports of serious drug reactions between January and March 2008 which is 38 percent higher than average and is the highest for any quarter reported. The 4,824 deaths between the three months was nearly a threefold increase. The two drugs at the center of the reports and are responsible for the most reactions were the blood thinner heparin imported from China and Chantix an anti-smoking drug from Pfizer. Chantix is at the top of the list for serious drug reactions. Earlier this year the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams. The ISMP study found that heparin accounted for 779 reports of serious drug reactions, including 102 deaths with a possible 238 deaths associated to the tainted heparin. “The FDA is aware of the increasing number of reports, and we take them seriously,” said spokesman Christopher DiFrancesco. Previous ISMP research has shown that reports of serious drug safety problems had increased markedly since the late 1990s. This seems to be an alarming trend in today’s drug market. The FDA must be overwhelmed by the increased reports of serious drug side effects which could offer the drug companies an opportunity to push through possibly dangerous drugs because of the FDA’s increased workload.

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