Another reason to stay healthy
The number of serious drug reactions and deaths reported to the government shot up in the first three months of this year to set a new 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, said an analysis of federal data by the Institute for Safe Medication Practices, known as ISMP.
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.
Clearinghouse for informationThe watchdog group that prepared the analysis has served hospitals and pharmacists for years as a clearinghouse for information on medication errors. Known as ISMP, the organization 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 senior scientist with 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 can only be established through painstaking investigation. If the FDA were a police agency, the reports would indicate “probable cause,” but not necessarily “guilt beyond a reasonable doubt.”
‘Significant drug safety problem’The ISMP study found that heparin accounted for 779 reports of serious problems, including 102 deaths. The FDA, using data that covers a longer time period, has reported 238 deaths possibly linked to heparin.
Heparin “illustrates an example of a significant drug safety problem that was promptly and effectively resolved by the drug manufacturers and the FDA once the issue was detected and understood,” the report said.
Most physicians believe the problem of drug reaction is severely under reported be cause of the amount of paperwork the doctor must do to make a report.