Novartis has issued new warnings for its antiepilepsy drug Trileptal (oxcarbazepine) that highlight the drug's serious skin-related side-effects such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
SJS is a hypersensitivity reaction of the skin and mucous membranes, some 15 per cent of which end in death. TEN, characterised by skin blistering and peeling, may also be fatal. While SJS and TEN are usually rare (0.5-6 cases per million population), patients taking Trileptal increase their risk by 3-10 times.
Life-threatening multiorgan (usually blood, liver and kidney) hypersensitivity has also been seen with the drug. Patients typically have fever and a rash.
If any of these adverse reactions is suspected, Novartis recommends discontinuing Trileptal immediately.