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USA. Le informazioni di sicurezza per i farmaci generici sono spesso diverse dai prodotti di marca

Medscape Medical News

Emma Hitt, PhD

18 dicembre, 2012

Generic drugs often differ from brand name drugs in their safety labeling despite standards mandated by the US Food and Drug Administration (FDA), according to a new report.

"Physicians should be aware of such differences and regulators should consider new strategies for harmonizing bioequivalent labels," Jon Duke, MD, from the Regenstrief Institute and Indiana University School of Medicine, both in Indianapolis, and colleagues write.

The researchers report their findings in an article published online October 8 in Pharmacoepidemiology and Drug Safety.

According to Dr. Duke and colleagues, the FDA requires that manufacturers of generics demonstrate that "their medications are ‘bioequivalent’ to reference-branded drugs — meaning that they have identical active ingredients, dose forms, and approximate pharmacokinetics." In addition, safety data on the labels of generics should be identical to those found on the brand label.

To investigate whether the safety data are equivalent, the researchers analyzed safety labels across bioequivalent generic medications using an automated system called the Structured Product Label Information Coder and Extractor (SPLICER). The team showed previously that the system has a 92.8% sensitivity and 95.1% positive predictive value.

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