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FDA Dilantin Investigation

November 11, 2008

Agency Investigating Dilantin Risks of SJS and TEN

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 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. Until the FDA 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. Healthcare providers should consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502. A summary of the data currently being analyzed by FDA, and information for patients and healthcare professionals to consider, can be found on the FDA's website.

SOURCE: U.S. Food and Drug Administration (FDA)

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If you or your child has suffered Stevens Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN) from taking dilantin, contact an attorney at our law firm to discuss your legal options.

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Dilantin Information:




Which product was taken:

Dilantin (phenytoin)
Dilantin Extended Oral Capsules
Dilantin Infatabs Chewable Tablet
Dilantin 125 Suspension in Bottle
Phenytoin Extended Release Capsules
Phenytoin Solution for Injection
Phenytek Extended Release Capsules
Tegretol (carbamazepine)
Levaquin (levofloxacin)
Other Drug
None of the Above


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