The study, published in the December 2012 issue of the Pharmacoepidemiology and Drug Safety journal, found that labels on generic drugs failed to match their brand-name counterparts in 78% of cases studied [1].

The authors decided to test the FDA requirement that bioequivalent medications must have identical warnings on their labels by studying electronic labelling for bioequivalent drugs from different manufacturers. This was carried out by investigating the adverse drug reactions (ADRs) found in the Adverse Reactions and Post-Marketing sections of 9105 structured product labels for more than 1,500 drugs on DailyMed, an online repository of labelling information maintained by the FDA and the National Library of Medicine.

The results showed that 68% of multi-manufacturer drugs had discrepancies in ADR labelling, while 77.9% of generics manufacturers had labels which differed from the brand-name product. Although the authors also pointed out that most of the generics labels showed relatively small differences from the brand-name labelling, errors included out-of-date information, incomplete data and, in one case, information for the wrong drug altogether. Causes of inconsistency included missing tables, outdated post-marketing reports and formatting issues.

To date generics manufacturers have been exempt from having to change labels to reflect new safety concerns until after the brand-name drugmaker changes their labelling [2]. In fact, under current FDA regulations, generics manufacturers cannot update labelling, even if they become aware of a potential risk not mentioned in the brand-name labelling. However, a bill introduced in April 2012 aims to pass legislation to permit generics manufacturers to proactively improve warning information in labelling even before the brand-name drugmaker does [3].

‘Physicians should be aware of such differences’, as they ‘frequently use labelling information, either directly or indirectly, to make prescribing decisions. They need to know about side effects, drug interactions and other safety issues,’ says lead author Dr Jon Duke of Indiana University School of Medicine.

The authors conclude that FDA ‘should consider new strategies for harmonizing bioequivalent labels’. Lead author, Dr Jon Duke, also supports a recent proposal put forth in the New England Journal of Medicine that calls for ‘consensus’ drug labels containing all safety information on a given drug regardless of the manufacturer.

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Black-box safety warnings and the future of generic drug liability

References

1.  Duke J, Friedlin J, Li X. Consistency in the safety labeling of bioequivalent medications. Pharmacoepidemiol Drug Saf. 2012 Oct 8. doi: 10.1002/pds.3351. [Epub ahead of print].

2.  GaBI Online - Generics and Biosimilars Initiative. Generics will not have to change their labelling [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jan 18]. Available from: www.gabionline.net/Generics/News/Generics-will-not-have-to-change-their-labelling

3.  GaBI Online - Generics and Biosimilars Initiative. Bill introduced to allow generics to change labelling [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jan 18]. Available from: www.gabionline.net/Policies-Legislation/Bill-introduced-to-allow-generics-to-change-labelling

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