Dangerous Skin Reactions from Carbamazepine

FDA is alerting healthcare professionals about dangerous and possibly fatal skin reactions to the drug carbamazepine in certain patient populations. The reactions have included Stevens Johnson syndrome and toxic epidermal necrolysis.

Carbamazepine is an anticonvulsant used to treat epilepsy, as well as mania/bipolar disorder and neuropathic pain. This drug is sold under the trade names Carbatrol, Equetro and Tegretol, and also as a generic.

These skin reactions are significantly more common in patients with a particular human leukocyte antigen allele called HLA-B*1502. This allele occurs almost exclusively in people with Asian ancestry, including South Asian Indians. Patients with this ancestry should be screened for the HLA-B*1502 allele before starting treatment with carbamazepine, using available genetic tests.

If test results are positive, the drug should not be started unless the expected benefit clearly outweighs the risk of serious skin reactions.

Patients who test positive for HLA-B*1502 may also be at increased risk from other antiepileptic drugs that have caused serious skin reactions. So clinicians should consider avoiding these drugs when other treatments are equally acceptable.

Patients who test negative for HLA-B*1502 have a low risk of developing serious skin reactions from carbamazepine, but these reactions can still occur, although rarely. So healthcare professionals should watch for symptoms in any patient taking this drug.

But note that over 90 percent of all serious skin reactions do occur within the first few months of treatment. This means that patients who have been on the drug for longer periods of time without developing skin reactions have a low risk of this kind of reaction in the future. And that includes even those who test positive for HLA-B*1502.

FDA Patient Safety News: March 2008

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=73#5

Category:

Education

Tags:

• Epilepsy
• mania
• bipolar
• Carbatrol
• Equetro
• Tegretol
• Asian
• genetic
• skin
• FDA
• drug
• reaction
• side
• effect

[kristiepattinson]

fucking hell i take this and i am now scared of taking it

[sikoftyra]

My dad is still in hospital after his skin went rotten from tip of head to soles of feet. The test results confirmed it was due to a drug reaction which led the dermatologist to suspect THIS drug caused it. Also his feet were purple and swollen and he had ulcers and thrush all through his mouth and down his throat. I will never forget it.

P.S I am unaware of any Asian ancestry.

[truethatdave]

One to laugh at a special blood line that dates back from the ancient samori warrior across asia amnd then italy! why would an irish decendant look down @ me in hate! thats not at all right! it dates back farther then 1200 bc!ancestery! line! royals! CTR!

[kellyasp52]

Why does this drug make my mouth and face tingly after I take it? Why does it change the way voices and music sound....its deeper for a while. Like charlie brown's teacher, haha, well, not that drastic. Ahhhhh...I have resigned to the fact that if the bipolar drugs don't kill me, then the bipolar itself will. Happy trails.

[Juno4EVA]

I had Toxic epidermal Necraliasis and im not asian. I had it due to aprin. PLEASE BE AWARE OF THE SIDE EFFECTS BEFORE TAKING ANY MEDICATION!

[sunnybay2xp]

wow

[virbra77]

nicely done.

[QTPieP2]

Good info!