Once again, an analysis of the U.S. system for reporting patient injuries caused by prescription drugs is yielding an unexpected side effect — incomplete information. And a key reason is inconsistent reports filed by drug makers, according to the Institute for Safe Medicines Practices, a nonprofit that tracks drug safety issues.
The Adverse Event Reporting System, which is run by the Food and Drug Administration, is the primary tool for collecting information about side effects that may be caused by medicines. Consumers and physicians may voluntarily report problems to the agency or to a drug maker. But drug makers are required to investigate and then report any side effect that may be attributable to one of their products.