Study Finds Incorrect Safety Labeling on Generic Drugs
A recent study found that most generic medications do not carry warnings identical to those on their brand-name equivalents despite a requirement that they do so from the U.S. Food and Drug Administration (FDA).
The study conducted by the Regenstrief Institute (http://www.eurekalert.org/pub_releases/2012-12/iu -rsf121312.php), which is affiliated with Indiana University, reveals that more than two-thirds of generic drugs have safety-warning labels that are not similar to the ones on the brand-name product.
The researchers reviewed more than 9,000 labels of over 1,500 drugs available on DailyMed, which is an online repository of labeling information maintained by the FDA and the National Library of Medicine. Almost 70 percent of the 1,040 drugs with more than one manufacturers label showed discrepancies within their safety information.
Most of the generics had small differences across their labels, but 9 percent showed differences regarding 10 or more side-effects. Out-of -date information, incomplete data, and information for the wrong drug were among the errors found in the labels of generic drugs.
Physicians rely on drug labeling information while writing patient prescriptions. And information on medication side effects is often conveyed to patients by their doctors or by pharmacists through information sheets accompanying a pharmacy purchase. So side effects and other safety issues need to be as clearly indicated on generic drugs as they are on brand-name drugs.
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