The FDA has issued warnings about Stevens-Johnson Syndrome (SJS), a rare but severe skin reaction to Dilantin. It is more likely in some people with Asian or African-American ancestry.
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Dilantin Allergic Skin Rash Warnings
Dilantin (phenytoin) is an anti-epileptic medication made by Pfizer that is used to control seizures. The Prescribing Information warns that severe allergic skin rashes have occurred in patients on Dilantin, including Stevens-Johnson Syndrome (SJS).
Dilantin and Stevens-Johnson Syndrome
SJS usually develops within 28 days, but sometimes later, and may be accompanied by a fever. It resembles measles or scarlet fever. Patients should seek emergency medical attention at the first sign of an allergic skin rash, unless the rash is clearly not drug-related.
Asians and African-Americans May Have Higher Risk
Doctors may recommend a blood test to check for a genetic risk-factor for developing SJS on Dilantin. Around 10% of Asian people in the U.S. have the gene. It is also found in around 0.4% of African-American and Alaska Natives. It is uncommon in Caucasian, Hispanic, and mainland Native Americans.
FDA Safety Warning for Dilantin SJS Risk in Asians
In November 2008, the FDA issued a Safety Alert after studies found a strong association between SJS and a gene called “HLA-B*1502.” The gene is found in 10-15% of people from China, Thailand, Malaysia, Indonesia, Philippines, and Taiwan. It is found in 2-4% of Indians and other South Asians. Less than 1% of people from Japan or Korea have the gene.
What is Stevens-Johnson Syndrome?
Stevens-Johnson Syndrome (SJS) is a rare but sometimes fatal skin rash. It is very painful, disfiguring, and can cause blindness or disability. It is almost always caused by allergic reactions to medications. When SJS is mild and linked to infections, it is often diagnosed as erythema multiforme.
Warning Signs of SJS
A flu-like illness, fever, and skin rash are usually the first symptoms of SJS. The rash can occur anywhere on the body or face. It spreads rapidly — within hours or days — and often to mucous membranes (eyes, mouth, throat, nose, genitals, or intestines). Over the next couple days, large fluid-filled blisters develop under the skin. The top layer of skin dies and peels off in large sections, like a bad sunburn.
SJS and Toxic Epidermal Necrolysis
SJS involves a rash on less than 10% of the body. When it covers at least 30% of the body, SJS is called Toxic Epidermal Necrolysis (TEN). Around 5% of cases of SJS are deadly. The risk increases to 30% for TEN. It is also sometimes diagnosed as Lyell’s syndrome, named after a doctor who described the first cases of TEN in the 1950s.
Symptoms of SJS
- Skin rash that spreads
- Flu-like illness
- Generally feeling sick
- Bloodshot eyes
- Sore mouth and throat
- Vision problems
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