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The U.S. Food and Drug Administration issued a healthcare provider alert for several antiepileptic medications because of the potential increased risk of serious skin reactions, including Stevens Johnson Syndrome and toxic epidermal necrolysis. Phenytoin (Dilantin, Phenytek) and fosphenytoin sodium (Cerebyx) have been associated with an increase in skin reactions, particularly among individuals of Asian ancestry, including Filipinos, Malaysians, South Asian Indians, Han Chinese, and Thais. A small percentage (<1%) of Japanese and Korean patients are also at risk. These ethnic groups appear to carry a particular human leukocyte antigen allele, HLA-B*1502, that increases their risk for reactions.

The same skin reactions were previously associated with carbamazepine (Tegretol) and oxcarbazepine (Trileptal) therapy. Skin reactions occur most often at the initiation of therapy, but they have also been reported during the first few months of drug therapy. While skin reactions can occur in any individual prescribed the associated antiepileptics, the incidence among individuals of Asian ancestry is particularly high. For example, all new users of phenytoin have a 0.3% risk of developing a serious skin reaction, compared to 3% among individuals of Asian ancestry.

While genetic tests for HLA-B*1502 are already available, their use is not widespread. The FDA strongly recommends that healthcare providers who are considering the use of phenytoin, fosphenytoin, carbamazepine, or oxcarbazepine among ethnic groups at risk should be aware of the risks and benefits described in the current prescribing information for these drugs. A thorough assessment of ethnic background is imperative, and individuals who are adopted and unaware of their ancestry also warrant close observation.

Nurses caring for patients recently diagnosed with epilepsy or seizure disorders should pay especially careful attention to skin inspection and monitoring for anaphylactic reactions.

Patient teaching: Stress careful inspection of the skin, especially when therapy begins or dosages are adjusted. Although benign rashes may occur with any medication, it is not possible to reliably predict which rashes will prove to be serious. Tell patients to immediately contact their healthcare providers if they notice rashes. Advise patients to immediately seek medical attention for any signs or symptoms suggesting angioedema or anaphylaxis (e.g., swelling of face, eyes, lips, tongue or larynx; difficulty in swallowing or breathing; hoarseness). Remind patients not to stop seizure control medications without talking with their healthcare providers.

Caution: Review current drug information before administering and monitoring medications.

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Drug News is compiled by Susanne J. Pavlovich-Danis, RN, MSN, ARNP-C, CDE, CRRN, who maintains a private practice in Plantation, Fla., and is professor and area chair for nursing at the University of Phoenix, Fort Lauderdale.