Warning about Lamotrigine
Glaxo Wellcome, the manufacturer of Lamictal® (lamotrigine) tablets, a new antiepileptic drug for adjunctive therapy of partial seizures in adults with epilepsy, recently released an important drug warning to health care professionals.
In each package of Lamictal®, a revised package insert advises that "severe, potentially life-threatening rashes have been reported... including Stevens-Johnson Syndrome and, rarely, toxic epidermal necrolysis..." and that "the incidence... in paediatric patients, however, is very much higher..."
Revised labeling now emphasizes that Lamictal® should not be used by people below 16 years of age. Reports from clinical trials "suggest that as many as 1 in 50 to 1 in 100 paediatric patients treated with Lamictal® develop a potentially life-threatening rash," as compared with a rate of approximately 1 in 1,000 adults. These revisions in labeling, agreed in consultation with the US Food and Drug Administration, "reflect additional information obtained through worldwide clinical experience in an estimated 600,000" people.
The revised labeling also advises that "hypersensitivity reactions, some fatal or life-threatening, have also occurred."
For more information or a copy of the news release, please contact the provincial office of Epilepsy Ontario.
Note: Since this article was published, Glaxo Wellcome contacted us to advise that lamotrigine is not currently approved for use in children under 18 years of age in Canada. Please refer to Sharing Volume 13 #2 for more information.
|
