Prescription drug reactions kill more than 100,000 a year

By BRENDA C. COLEMAN

April 15, 1998

Associated Press

CHICAGO _¯ Bad reactions to prescription and over-the-counter medicines kill more than 100,000 Americans and seriously injure an additional 2.1 million every year _¯ far more than most people realize, researchers say.

Such reactions, which do not include prescribing errors or drug abuse, rank at least sixth among U.S. causes of death _¯ behind heart disease, cancer, lung disease, strokes and accidents, says a report based on an analysis of existing studies.

"We're not saying, 'Don't take drugs.' They have wonderful benefits," said Dr. Bruce H. Pomeranz, principal investigator and a neuroscience professor at the University of Toronto.

"But what we're arguing is that there should be increased awareness also of side effects, which until now have not been too well understood."

The harm may range from an allergic reaction to an antibiotic to stomach bleeding from frequent doses of aspirin, Pomeranz said. The study, by Pomeranz and two colleagues at his school, Jason Lazarou and Paul N. Corey, did not explore which medications or illnesses were involved.

The authors analyzed 39 studies of hospital patients from 1966 to 1996. Serious drug reactions affected 6.7 percent of patients overall and fatal drug reactions 0.32 percent, the authors reported in Wednesday's Journal of the American Medical Association.

In the study, serious injury was defined as being hospitalized, having to extend a hospital stay or suffering permanent disability.

The most surprising result was the large number of deaths, the authors said. They found adverse drug reactions ranked between fourth and sixth among leading causes of death, depending on whether they used their most conservative or a more liberal estimate.

In 1994, between 76,000 and 137,000 U.S. hospital patients died, and the "ballpark estimate" is 106,000, Pomeranz said. The low estimate, 76,000 deaths, would put drug reactions sixth. The ballpark estimate would put them fourth, he said.

An additional 1.6 million to 2.6 million patients were seriously injured, with the ballpark estimate 2.1 million, he said.

More than two-thirds of the cases involved reactions outside hospitals rather than in hospitals, the authors reported.

Experts commended the study but disagreed whether the estimates are on target.

Dr. David W. Bates of Partners Healthcare Systems and Brigham and Women's Hospital in Boston said the estimates may be high. One reason, he said, is that they may over-represent large medical centers, which treat sicker than average patients, who are more prone to reactions.

"Nonetheless, these data are important, and even if the true incidence of adverse drug reactions is somewhat lower than that reported ... it is still high, and much higher than generally recognized," he said.

Dr. Sidney M. Wolfe, director of the consumer advocacy Public Citizen Health Research Group, said he believes the numbers are on target.

"I've read most of these studies, and they represent large hospitals, small hospitals ... a heterogeneous sample of the kinds of hospitals in this country, and include a whole range," Wolfe said by telephone Tuesday from Washington.

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