Generic drug safety labels often contain incorrect information, study finds

INDIANAPOLIS — More than two-thirds of generic drugs carry safety warning labels different from those of their branded equivalents, according to a new study.

Researchers at the Regenstrief Institute, a research organization supported by the Regenstrief Foundation and located on the campus of Indiana University Purdue University Indianapolis, reviewed 9,105 product labels for more than 1,500 drugs available on the Food and Drug Administration's and National Library of Medicine's online labeling information repository DailyMed. Of more than 1,040 drugs with more than one manufacturer's label, 68% had discrepancies within their safety information.

Using a software program they developed, the researchers found that most of the generic showed relatively small differences, but 9% showed differences of more than 10 side effects, and other errors included out-of-date information, incomplete data and one that had information for the wrong drug. The study was published online in the journal Pharmacoepidemiology and Drug Safety and will be published in the print edition as well.

"Physicians frequently use labeling information, either directly or indirectly, to make prescribing decisions," lead study investigator and Indiana University professor of medicine Jon Duke said. "They need to know about side effects, drug interactions and other safety issues. We found that generic drug labels may contain incomplete or incorrect safety information. Until this problem is resolved, physicians and patients should rely on brand drug labeling only, even when the patient is getting a generic version of a drug."


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