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

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

icon 2024-02-21

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

2008-11-26