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FDA Examines Anti-Epileptic Drugs

-November 25, 2008 

The Food and Drug Administration (FDA) is currently conducting a study to evaluate whether particular anti-seizure medications put Asian patients at risk of developing severe skin (epidermal) problems.

In this ongoing study, the FDA is evaluating the drugs:

• Dilantin
• Phenytek
• Cerebyx

Possible Side Effects

Although such medications are effective at treating seizures (and, in some cases, mania), they are also known to cause painful blisters and bleeding in patients who test positive for a certain gene, specifically HLA-B1502.

Additionally, some of these at-risk patients can develop more serious skin disorders, including:

• Stevens Johnson syndrome, a condition in which swelling of the mucous membranes causes flu-like symptoms and, eventually, the death of the top-layer of a person's skin

• Toxic epidermal necrolysis, a life-threatening disorder in which the top-layer of a person's skin separates from the lower layers.

Who Contains HLA-B1502?

Between 10 and 15 percent of the following peoples contain the specific gene that puts them at risk of the epidermal complications associated with anti-epileptic medications:

• Chinese
• Filipino
• Indonesian
• Malaysian
• Thai

Between 2 and 4 percent of South Asians (including Indians) contain HL-B1502.

Study Follows Prior Findings

This FDA research is a follow-up study to an earlier investigation that found that carbamazepine (another anti-seizure medication sold under the brand names Tegretol and Carbatrol) caused some Asian patients to experience skin-related health problems.

In the case of carbamazepine, the FDA has recommended that doctors perform genetic testing to find out whether patients carry HL-B1502 before prescribing this medication.

While the FDA has not yet made such recommendations for Dilantin, Phenytek and Cerebyx, it has warned healthcare professionals that skin complications will develop within about 12 weeks of taking these medications.

Similarly, the FDA has also warned that doctors should avoid prescribing Dilantin, Phenytek and Cerebyx to any patient who has already developed an epidermal complication from taking carbamazepine.

(Source: Seattle Post-Intelligencer)

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