Reports of Bad Drug Reactions Rose 14% in ’85
The Food and Drug Administration received nearly 37,000 reports of adverse reactions to drugs in 1985, a 14% increase over the previous year, officials reported Thursday.
The federal agency said the rise in reports did not mean drugs were causing more complications, only that physicians and drug companies were more readily complying with the FDA’s national drug surveillance program.
“More people have become aware of (the reporting system) and more are using it,” said Mike Shaffer, an FDA spokesman. “This reflects a trend in the medical community to report more on a drug after approval, allowing us to know better what’s going on and making it easier to approve new drugs.”
FDA researchers, reporting in the Journal of the American Medical Assn., said that in the late 1970s and early 1980s, only about 10,000 adverse drug reaction reports reached the agency. The number of reports exceeded 30,000 in 1984 and jumped 14% to 36,931 in 1985, they said.
Of the reactions reported in 1985, 2% involved deaths and 21% involved hospitalizations.
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