Incorrect drug labels may pose threat to patients

Posted by Pharmacist on March 20, 2013

More than two-thirds of generic drugs carry different warning labels than their corresponding brand-name products, according to a recent study. Investigators at the Regenstrief Institute reviewed 9,105 labels for more than 1,500 drugs available through DailyMed, an online resource that compiles drug information from the National Library of Medicine and the Food and Drug Administration (FDA).  There were 1,040 drugs in the study with more than one manufacturer’s label and 68 percent of those had differing safety information.

The study was led by Jon Duke, M.D., M.S., an assistant professor of medicine at the Indiana University School of Medicine. While the study showed most label differences were minor nine percent had discrepancies in more than 10 side effects. This is problematic, because as Duke said “Physicians frequently use labeling information, either directly or indirectly, to make prescribing decisions.”

Potential side-effects and interaction information is typically passed on to the patient by the doctor, the pharmacist and/or via drug information sheets. During the study investigators found that some of the labels had incomplete or out-of-date information and in the case of one label, information for a different drug.

To solve this issue, Duke suggests an independently compiled listing of side-effects that could be referenced on all drugs regardless of the manufacturer. Until then he says “Physicians and patients should rely on brand drug labeling only, even when the patient is getting a generic version of a drug.”

To see the complete report, visit Wiley Online Library

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