Abstract Details

Several second-generation ASMs are considered the mainstay of treatment due to improved pharmacokinetic properties, efficacy, and tolerability. Little is known about their long-term adverse events from post-market surveillance. Understanding adverse events and safety profiles of commonly used ASMs is essential to make informed clinical decisions.

To analyze the reports of postmarketing adverse events in patients treated with second-generation antiseizure medications (ASMs).

The frequency of adverse events of 17 FDA-approved second-generation ASMs reported between January 2014 and June 2021 were collected using the OpenFDA Application Programming Interface. Adverse events representing less than 2% of total reports were excluded for each drug. Reporting odds ratios (ROR) and information components were calculated for each adverse event for all ASMs.

Total adverse event reports studied were 15414 for oxcarbazepine, 59438 for lamotrigine, 54262 for levetiracetam, 7015 for zonisamide, 4169 for perampanel, 1131 for stiripentol, 16304 for lacosamide, 166882 for pregabalin, 1101 for felbamate, 3147 for eslicarbazepine, 12230 for cannabidiol, 47472 for topiramate, 219997 for gabapentin, 4063 for brivaracetam, 7084 for vigabatrin, 685 for tiagabine, and 1501 for rufinamide. In 14 out of 17 drugs, the most common adverse event reported was seizure (ROR >10); however, this may reflect increased risk in the population these drugs are used in. Eosinophilic reaction with systemic symptoms was associated with lamotrigine (ROR 18.6) and felbamate (ROR 19.7). Hyponatremia was associated with oxcarbazepine (14.8) and eslicarbazepine (ROR 35.1). Vigabatrin was associated with infantile spasm with the highest ROR of 1309. Other adverse events noted were aggression/anger, migraine/headache, and tachycardia.

This comprehensive analysis of postmarketing data from the FDA Adverse Event Database shows differences in safety profiles between new generation ASMs. Rigorous post-market surveillance and further research is required to better understand the long-term safety of these drugs to make informed clinical decisions.