US drugmakers' reports on side effects often incomplete: study

New York

THE main system for keeping track of the dangerous side effects of prescription drugs is deeply flawed, primarily because drugmakers are submitting incomplete information about the problems to the Food and Drug Administration (FDA), according to a new study by a non-profit group that tracks drug-safety issues.

The study, by the Institute for Safe Medicine Practices, found that only about half of reports of serious side effects submitted by manufacturers met basic standards for completeness, containing a patient's age, sex and the date the event took place. Reports collected by the FDA itself, by contrast, were found to meet those basic standards in 85 per cent of cases.