Regenstrief study finds that generic drugs often have incorrect safety labeling

Despite US Food and Drug Administration regulations requiring generic medicines to carry identical warnings to those on corresponding brand-name products, a study by USA-based Regenstrief Institute researchers has found that more than two-thirds of generic drugs have safety-warning labels that differ from the equivalent brand-name drug.

The investigators reviewed 9,105 product labels for over 1,500 drugs available on DailyMed, an on-line repository of labeling information maintained by the FDA and the National Library of Medicine. Of the 1,040 drugs with more than one manufacturer’s label, 68% showed some discrepancies within their safety information.

The majority of generics showed relatively small differences across their labels, but 9% showed differences of more than 10 side effects. Errors included out-of-date information, incomplete data and, in one case, information for the wrong drug altogether.