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FDA reports show blood thinner, anti-smoking drug account for large share
Published on Thursday, Oct 23, 2008
WASHINGTON: The number of serious drug reactions and deaths reported to the government shot up in the first three months of the year to set a record, a health industry watchdog group said Wednesday.
The Food and Drug Administration received nearly 21,000 reports of serious drug reactions, including more than 4,800 deaths, according to 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 heparin, the tainted blood thinner from China that caused an international safety scandal. The other was Chantix, a new kind of anti-smoking drug from Pfizer.
Chantix, which had the most reports of any medication, works directly in a smoker's brain to ease withdrawal symptoms. It also blocks the pleasurable effects of nicotine if the patient is tempted to light up again. Earlier this year, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams. Pfizer said Wednesday it stands by Chantix, and that the volume of reports might be linked to publicity about the side effects.
''The FDA is aware of the increasing number of reports, and we take them seriously,'' said spokesman Christopher DiFrancesco. But officials are not sure whether reports are up because problems are getting worse, or simply because of greater awareness of drug safety issues.
The watchdog group that prepared the analysis has served hospitals and pharmacists for years as a clearinghouse for information on medication errors. The ISMP is now trying to reach consumers with regular reports on drug safety trends.
''We believe that one of the most important tools to promote is to monitor trends on a regular basis,'' said Thomas J. Moore, a scientist with the ISMP. ''Knowing which drugs are causing injuries and how many people are being hurt is the raw material we need to fashion sound measures to promote patient safety.''
The FDA defines serious drug reactions as ones that cause hospitalization, require medical intervention, or place a life in jeopardy. The agency's monitoring system relies on voluntary reports from doctors and is only believed to capture a fraction of overall problems.
The 20,745 cases reported from January through March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter, the report said. The number of deaths, 4,824, was a nearly threefold increase from the last calendar quarter of 2007. The FDA said heparin was largely to blame.
Previous ISMP research has shown that reports of serious drug-safety problems had increased markedly since the late 1990s.
The FDA case reports provide a signal of possible problems with a drug, but a cause-and-effect connection only can be established through painstaking investigation.
WASHINGTON: The number of serious drug reactions and deaths reported to the government shot up in the first three months of the year to set a record, a health industry watchdog group said Wednesday.
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