Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)

On April 28, 2005 Health Canada posted an alert on its web site concerning the association of Trileptal (oxcarbazepine), an anti-epileptic medication, with life-threatening dermatological reactions and multi-organ hypersensitivity.  It also posted on its site a "Dear Health Care Professional" letter by Novartis Pharmaceutical Cananda, Inc., dated April 27, 2005 in which the drug’s manufacturer informed doctors about new safety information concerning the risks of these serious side effects.  The letter can be viewed at:

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_advisories_professionals_e.html#2005

A similar warning was issued by the US FDA and Novartis AG on April 19, 2005.

Trileptal is prescribed for the treatment of partial seizures in adults and in children ages 6 to 16 with epilepsy.

According the April 27 Novartis letter, the reporting rate of Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) currently exceeds the background incidence rate estimates by a factor of 3-fold to 10-fold.  Novartis advises that most cases of SJS and TEN which have been associated with a patient’s use of Trileptal occurred within the first month.  Some of these patients required hospitalization, and there were a few deaths reported. 

Novartis has issued a revised Trileptal Product Monograph, also referred to as the "package insert", warning that a diagnosis of SJS or TEN requires immediate discontinuation of Trileptal.

As a general rule, patients should not stop taking any medication prescribed by their doctor without first consulting with that doctor.  If, however, a patient taking Trileptal or any other prescription medicine experiences a serious skin rash, that patient should not delay in reporting this condition to a doctor, be it the prescribing doctor or another doctor.

Lastly, as always, Health Canada encourages people that any suspected adverse reaction to a prescription drug should be reported to the Canadian Adverse Drug Reaction Monitoring Program (CADRMP).  Likewise, in the United States, any serious side effects to prescription drugs should be reported to the FDA through their MedWatch Program.

(Posted by: Tom Lamb)