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Wednesday, 20 April 2011

Health Canada warns of serious skin reactions in patients taking carbamazepine

Health Canada has issued an advisory concerning carbamazepine, a drug commonly used to treat epilepsy, mania, bipolar disorder and trigeminal neuralgia, a facial condition.
Carbamazepine is sold in Canada under the name Tegretol.
The advisory stems from reports of serious skin reactions in patients of Asian ancestry taking the drug.
"Serious and sometimes fatal skin reactions known as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis have been known to occur very rarely with carbamazepine," reads the advisory. "While all patients treated with carbamazepine are at risk of these skin reactions, the risk is approximately 10 times higher in Asian countries than in Western countries."
According to Health Canada, a genetic test is available that can identify a genetic marker in patients of Asian ancestry that has been linked to an increased risk of developing serious skin reactions to carbamazepine. The health agency encourages people who are considering taking the medication to consult with their doctors about this test.
Health Canada said it is revising the prescribing information for Tegretol and is also in the process of revising prescribing information for all generic carbamazepine products to include the possibility of serious skin reactions.
The following generic carbamazepine-containing products, with their makers in brackets, are sold in Canada:
  • Apo-carbamazepine (Apotex Inc.).
  • Bio-carbamazepine (Biomed 2002 Inc.).
  • Carbamazepine (Pro Doc).
  • Dom-carbamazepine (Dominion Pharmacal).
  • Gen-carbamazepine (Genpharm ULC).
  • Mazepine (Valeant Canada Ltd.).
  • Novo-carbamaz (Novopharm Ltd.).
  • Nu-carbamazepine (Nu-Pharm Inc.).
  • PHL-carbamazepine (Pharmel Inc.).
  • PMS-carbamazepine (Pharmascience Inc.).
  • Sandoz-carbamazepine (Sandoz Canada Inc.).
  • Taro-carbamazepine (Taro Pharmaceuticals Inc.).
  • Tegretol (Novartis Pharmaceuticals Canada Inc.).
It warns patients who are not experiencing any skin reactions not to stop treatment before speaking with their physician.
However, all patients currently taking the drug should consult with a doctor immediately if they experience any signs of serious skin reactions such as a rash, red skin, blistering of the lips, eyes or mouth, or peeling skin accompanied by a fever.
As well, patients who have taken carbamazepine before and experienced skin reactions should not take the drug again, Health Canada said.


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