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 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 acro