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Safety Info Variations Found between Branded, Generic Drugs

Jon Duke (Regenstrief Institute)

Jon Duke (Regenstrief Institute)

Researchers at the Regenstrief Institute and Indiana University School of Medicine in Indianapolis found safety warnings on drug labels vary on a large majority of drugs between their brand-name and generic equivalents. The findings of the team led by Regenstrief professor of internal medicine Jon Duke appear online in the journal Pharmacoepidemiology and Drug Safety (paid subscription required).

Duke (pictured left) and colleagues examined 9,105 product labels from more than 1,500 drugs indexed in the DailyMed repository of drug labeling information maintained by the FDA and the National Library of Medicine. The researchers extracted drug safety data from medication labels using a software program written by Duke and colleagues called Structured Product Label Information Coder and Extractor, or SPLICER, that has a documented accuracy of 94 percent.

The researchers found two-thirds of the 1,040 drugs with more than one manufacturer’s label have some discrepancies in safety information between the original branded and subsequent versions. The majority of the variations, say the researchers, amounted to small differences in labeling.

However, nine percent of the drugs had differences in more than 10 side effects. Other errors found include out of date or incomplete information. In one case, information for the wrong drug was given.

Safety information generally comes from clinical studies conducted by the brand name manufacturer before the medication goes on the market. FDA does not require that generic manufacturers duplicate these studies. That safety information appears on medication labels and information sheets that accompany purchased drugs, which in turn are often the basis of information on medication side effects conveyed to patients by their doctors or pharmacists.

“We found that generic drug labels may contain incomplete or incorrect safety information,” notes Duke.  “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.”

Duke urges the industry to consider a centralized listing of drug side-effects, maintained independently of individual manufacturer labels that drug labels could reference rather than maintaining the information in a single document. “Clinicians could refer to this resource for the most up-to-date safety information regardless of generic manufacturer,” Duke adds.

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