- The Washington Times - Tuesday, September 11, 2007

Serious health problems linked to prescription drugs have more than doubled since 1998, according to a study released yesterday.

That year, the Food and Drug Administration (FDA) received 34,966 reports of bad reactions to drugs, compared with 89,842 in 2005. During the eight-year span of the study, the number of health problems increased each year, totaling 447,809. The study appears in yesterday’s issue of Archives of Internal Medicine.

A serious adverse event, as defined by the FDA, includes a reaction to a drug that results in death, a birth defect, disability or hospitalization. These events are reported to the FDA directly by drug manufacturers, which are informed of the events by consumers and doctors.

“The study once again shows people shouldn’t take prescriptions casually or rush to take a pill because they hear about it on TV,” said Bill Vaughan, a health policy analyst at Consumers Union. “Even old medicines we think are safe can be deadly — various forms of acetaminophen caused at least 2,400 deaths over eight years.”

Reports of health problems rose four times faster than the number of prescriptions written over the same period, the study shows.

The study did not pin blame on why health risks associated with drugs have steadily increased but noted one potential explanation is that doctors and patients are more likely to report problems now than they were than 10 years ago, given the publicity surrounding lawsuits against drug makers.

Mr. Vaughan noted that many more episodes involving health problems and medications might have gone unreported. He estimated that less than 10 percent of such events are reported to the FDA.

Nearly 1,500 drugs were linked to serious health problems in the study, but 51 drugs each generated more than 500 reports during each year of the study and accounted for 44 percent of the total number of adverse events.

Pain relievers caused a large percentage of the health problems. The study attributed 5,548 fatalities to Oxycodone over eight years, ranking it No. 1 among drugs that caused deaths.

“Contrary to our expectations, drugs related to safety withdrawals were a modest share of all reported events and declined in importance over time,” the study said. “Among the most frequently reported drugs associated with fatal events, we observed a disproportionate contribution of pain medications and drugs that modify the immune system.”

Not all drug risks can be discovered through clinical trials, said Ken Johnson, vice president of the Pharmaceutical Research and Manufactures Association, the largest trade associat. Mr. Johnson emphasized that the federal government’s role in monitoring the safety of drugs should be increased through legislation already passed by the House and Senate.

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