Dilantin FDA Alert!

FDA ALERT:

FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for a particular human leukocyte antigen (HLA) allele, HLA-B*1502.

This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians, and Thais.

Because fosphenytoin is a pro drug and is converted to phenytoin after administration, any concern regarding this association is also applicable to fosphenytoin. Phenytoin and fosphenytoin are used to control tonic-clonic (grand mal) and complex-partial seizures in epilepsy. The FDA is working to identify additional information to evaluate the possible risk of SJS/TEN from phenytoin and fosphenytoin inpatients with HLA-B*1502. Until the evaluation is completed, healthcare providers who are considering the use of phenytoin or fosphenytoin should be aware of the risks and benefits described in the current prescribing information for this drug.

Peterson& Associates, P.C. is dedicated to help patients who have suffered injury from the use of Dilantin. If you or someone you know has suffered from Dilantin®, please contact us.