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Safety Alert: Phenytoin
Warning About Serious Skin Reactions with Use of PHENYTOIN in Asians
What does this mean?
Patients who are Asian and have tested positive for a specific gene called HLA-B*1502 are at an increased risk for these serious skins when taking PHENYTOIN, or its brand version. This gene occurs mostly in patients with ancestors from broad areas of Asia, including Thais and Han Chinese. If you have Asian ancestry and are taking PHENYTOIN (or a brand name version) 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.
In the Caucasian and Japanese population, the frequency of HLA-B*1502 is extremely low, and thus it is not possible at present to conclude on risk association. Adequate information about risk association in other patients of other ethnic origin is currently not available. However, the benefits of PHENYTOIN will continue to outweigh the risks for most patients of these origins.
If you have any questions about this safety alert or if you think you are experiencing side effects from PHENYTOIN, please follow up with your doctor or healthcare provider.
In the January 2010 Drug Safety Update, the MHRA warns about an increased risk of serious skin reactions from PHENYTOIN (common brand name EPANUTIN) in Asian patients who have tested positive for a specific gene.
PHENYTOIN is a commonly used antiepileptic drug to control seizures. PHENYTOIN use is one of the most common causes of antiepileptic-related skin reactions, including life-threatening Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These serious skin reactions often begin with several days of flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters. A recent study has shown an increase risk of SJS in patients of Thai or Han Chinese ethnic origin who take PHENYTOIN.
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