Stevens Johnson syndrome or related toxic epidermal necrolysis may be caused by carbamazepine therapy, especially in patients of Asian ancestry with a particular HLA allele, according to an FDA safety alert.

The HLA-B*1502 allele is found almost exclusively in patients of Asian ancestry and is particularly prevalent in China, Thailand, Malaysia, Indonesia, the Philippines, and Taiwan, and to a lesser degree in South Asia, including India.

The agency recommended genetic testing for the HLA-B*1502 allele before prescribing carbamazepine for most patients of Asian ancestry. Carbamazepine is FDA-approved for treatment of epilepsy, mania/bipolar disorder, and neuropathic pain.

If patients test positive, carbamazepine should not be started unless the expected benefit clearly outweighs the increased risk of serious skin reactions, said the FDA. If patients test negative, they have a low risk, but dangerous skin reactions can still rarely occur.

Patients who have been taking carbamazepine for more than a few months without developing skin reactions are at low risk of these events ever developing from carbamazepine, the agency added.

Post-marketing adverse events reported to the World Health Organization and carbamazepine manufacturers pointed to a rate of the skin conditions that is about 10 times higher in Asian countries than in mainly Caucasian populations.

One study pointed to 5% absolute risk of Stevens Johnson syndrome and toxic epidermal necrolysis in HLA-B*1502-positive patients exposed to carbamazepine.

Revised product information will indicate the association of carbamazepine with the two skin disorders, the FDA said.

Stevens Johnson syndrome and toxic epidermal necrolysis are blistering reactions of the skin and mucous membranes that can be permanently disabling or fatal. The rash, which is often preceded by flu-like symptoms, usually appears across the face or trunk, and may spread to other parts of the body.

We're here to help!

We live by our creed of "helping those who need it most" and have helped thousands of clients get the justice they desperately needed and deserved. If you feel you have a case or just have questions please contact us for a free consultation. There is no risk and no fees unless we win for you.

Fields marked    may be required for submission.
  1. I'm an attorney

Levetiracetam linked to serious and life-threatening...

Gustav was on the anti-seizure medication Keppra for a year when his insurance company switched him to...

Dangerous skin reactions from Carbamazepine

A March 2008 FDA patient safety news bulletin reiterated warnings to healthcare professionals about...

Stevens Johnson Syndrome a Rare Skin Disorder

Stevens-Johnson syndrome is a rare, serious disorder of the skin and mucous membranes. It begins with...

FDA Issues an FDA Alert for Fatal Skin Reactions...

Dangerous or even fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that...

Warnings Added to Prescribing Information

Updates safety information to include warnings regarding serious rash, including Stevens-Johnson...

Naples Student Dies Following Reaction to Medicine

Naples High students are mourning the loss of Troy Goode, a senior who died Thursday night after a...

I never dreamed how much this would mean to me

I received another check today, much to my surprise. Thank you, thank you, thank you! I never dreamed how much this would mean to me in my golden years, as I have had hearing problems for years and needed to update my hearing aids, but with a limited income, found that was impossible. I now have the best hearing aids that I have ever had, thanks to you fighting so hard on my behalf.