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Generic Drugs’ Safety Labeling Often Incorrect

By Staff


1/23/2013

US Pharm. 2013;38(1):7.

Indianapolis, IN—Although generic drugs are required to carry warnings identical to those on corresponding brand-name medications, a study by the Regenstrief Institute has found that more than two-thirds of generics have labeling discrepancies. Investigators reviewed more than 9,100 product labels for more than 1,500 drugs available on DailyMed, an online repository of labeling information maintained by the FDA and the National Library of Medicine. Sixty-eight of 1,040 drugs with more than one manufacturer’s label had discrepancies in safety information. Most generics showed fairly small differences across labels, but 9% of them had differences of more than 10 side effects. Errors included out-of-date information, incomplete data, and (in one case) information for an entirely different drug.

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