Dilantin linked to SJS and TEN
Posted by Administrator (admin) on Nov 25 2008 at 4:57 PM
Dilantin >>

ROCKVILLE, Md., Nov. 24 – FDA says that using of the antiepileptic drug Dilantin (Phenytoin, Phenytek) to treat Asian patients with a particular human leukocyte antigen (HLA) allele possibly will enhance the risk of severe skin reactions.

According to the agency, patients with the HLA-B*1502 allele - common in those with Han Chinese, Filipino, Malaysian, South Asian Indian, and Thai ancestry – can increase the risk of Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

FDA has included Cerebyx (Fosphenytoin sodium) also in the warning. Cerebyx is a prodrug that is converted to phenytoin after administration.

FDA had issued a warning last year regarding the risk of Stevens Johnson syndrome and toxic epidermal necrolysis with carbamazepine. Carbamazepine is another antiepileptic drug using in patients of Asian ancestry with the HLA-B*1502 allele.

FDA asked healthcare providers to consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502.

FDA said that the risk of developing skin reaction with phenytoin appears to be greatest in the first few months of therapy.

FDA said that the investigation regarding the risks of these drugs is still in progress.

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