FDA issues alert over safety of epilepsy drugs

ROCKVILLE, Md. The Food and Drug Administration said Monday that it was investigating preliminary data that indicated an increase in serious skin reactions among Asian patients using the epilepsy drugs phenytoin and fosphenytoin sodium.

The FDA has received reports of the drug causing reactions such as toxic epidermal necrolysis and Stevens Johnson syndrome among Asian patients who test positive for the human leukocyte antigen allele, HLA-B*1502. The allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Filipinos, Malaysians, South Asians, Thais and Han Chinese.

The FDA said healthcare providers should consider avoiding phenytoin and fosphenytoin sodium as alternatives for carbamazepine in patients who have the allele.

Phenytoin is marketed as Pfizer’s Dilantin, Mylan’s Phenytek and as a generic drug. Fosphenytoin sodium is marketed in generic versions and as Parke Davis’ Cerebyx.