Associated Press
October 23, 2008
SourceWASHINGTON - The number of serious drug reactions and deaths reported to the government shot up in the first three months of this year to record highs, a health industry watchdog group said yesterday.
The Food and Drug Administration received nearly 21,000 reports of serious drug reactions, including some 4,800 deaths, said an analysis of federal data by the Institute for Safe Medication Practices.
Two drugs accounted for a large share of the latest reports. One was the blood thinner heparin. Most of the drug's problems were prompted by tainted heparin imported from China. The other was Chantix, a new kind of antismoking drug from Pfizer.
Chantix works in a smoker's brain to ease withdrawal symptoms. It also blocks the pleasurable effects of nicotine. Earlier this year, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams. Pfizer said yesterday it stands by Chantix, and that the volume of reports might be linked to publicity about the side effects.
The FDA defines serious drug reactions as ones that cause hospitalization, require medical intervention, or place a life in jeopardy.
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