Serious Drug Reactions Reported Hits a Record High



According to a report from the nonprofit Institute for Safe Medication Practices (ISMP), the Food and Drug Administration received almost 21,000 reports of serious drug reactions, including more than 4,800 deaths, from the first three months of 2008. The ISMP has tallied data over the last four years, and looked at yearly totals since the ’90s. This latest report was nearly 40 percent higher than results from the last four quarters, and the highest of any quarter tallied. Fatalities accounted for 23 percent of the drug reactions, an increase of three percent over the last calendar quarter from 2007.

A serious drug reaction is defined by the FDA as “ones that cause hospitalization, require medical intervention, or place a life in jeopardy.” The reports rely on voluntary information received from doctors. It is believed that there are many more problems than the fraction reported. Drug safety problems reported to the FDA increased between 1998 and 2005. However, the case reports can only provide an idea of possible problems with a drug, but only an investigation can show a cause-and-effect connection. This is equivalent to indicating “probable cause” and not necessarily “guilt beyond a reasonable doubt.”

The two drugs that take the brunt of this report are the blood thinner Heparin and the anti-smoking drug Chantrix. Tainted Heparin traced to China sickened and killed hundreds at the end of 2007 and beginning of 2008. The ISMP says that the Heparin case “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.”

Chantrix has been linked to psychiatric problems, including vivid dreams and suicidal behavior. The government has even gone so far as to ban the drug for pilots. Pfizer, the manufacturer or Chantrix stands by the drug. The ISMP report states the belief that the FDA should increase the language of the warnings (currently only stating that patients may be too impaired to operate heavy machinery or drive) to include blackouts and other problems that may lead to accidents. The report shows 15 cases of Chantrix users involved in auto accidents, and another 52 of blackouts or loss of consciousness.