US FDA issues alert on potential increased risk of serious skin reactions with phenytoin and fosphenytoin

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US FDA issues alert on potential increased risk of serious skin reactions with phenytoin and fosphenytoin

Warning Date
2008-11-26
Warning Reason
Correction Actions
Advices to Consumer

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 prodrug 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

Source: U.S. Food and Drug Administration


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