Safety Alert: Phenytoin
New Safety Information for Phenytoin
FDA is investigating a potential increased risk of serious skin reactions from PHENYTOIN (DILANTIN) in Asian patients who have tested positive for a specific gene. These serious skin reactions include Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) which often begin with several days of flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters. PHENYTOIN is used to control seizures.
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What does this mean?
These serious skin reactions are rare and it is important to avoid making too many conclusions until the FDA completes its review of this new information about the possible increased risk of skin reactions in Asians who are taking PHENYTOIN.
This safety alert only applies to patients who are Asian and have tested positive for a specific gene called HLA-B*1502. This gene occurs mostly in patients with ancestors from broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians, and Thais. If you have Asian ancestry and are taking PHENYTOIN or about to start this medicine, you should follow up with your doctor to find out if you have been tested for this gene. If you have tested positive for this gene, treatment with PHENYTOIN is not recommended.
