Literature Monitor

Similar Adverse Effects Reported in Generic vs Brand AEDs

Differences in reported AEs were likely due to biases against unapproved generics.


 

Although a recent analysis of adverse effects (AEs) found differences between AEs reported for generic versions compared with brand name versions of the 3 common antiepileptic drugs (AEDs), when approved generic formulations were compared to unapproved generics, reporting odds ratios were similar for authorized generic AEDs and generic AEDs. The researchers concluded that the differences were the result of perception biases. There were differences in drug AE reports of suicide and suicide ideation between authorized generic and brand name drugs that could not be explained by bias.

Rahman MM, Alatawi Y, Cheng N, et al. Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) [published online June 3, 2017]. Epilepsy Res. doi: http://dx.doi.org/10.1016/j.eplepsyres.2017.06.007

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