Lamictal Lawsuits

Lamictal is an antiepileptic drug. A boxed warning was added to Lamictal label in March 1997 including reports of severe, potentially life-threatening rash, and toxic epidermal necrolysis.

Also, the revised Lamictal label emphasized Lamictal is not indicated for use in patients below the age of 16 years. Lamictal pediatric patients had a higher risk of developing a potentially life-threatening rash. At the time of the Lamictal revised labeling there were an estimated 600,000 patients.

At the start of 2003, GlaxoSmithKline announced a labeling change was being made for Lamictal. Lamictal is now indicated in patients as young as two years with epilepsy as adjunctive therapy for partial seizures, as well as for generalized seizures of Lennox-Gastaut syndrome. Despite this Lamictal labeling change, safety and effectiveness for Lamictal patients under 16 years of age has not yet been established other than those with partial seizures and the generalized seizures of LGS.

In June 2003, GlaxoSmithKline's Lamictal became the first medication since the introduction of Lithium to be approved for the long-term treatment of bipolor disorder. The Lamictal announcement marks a significant change in bipolar treatment, but the effectiveness of Lamictal in the acute treatment of mood episodes has not yet been recognized.

Warnings on Lamictal labeling also include reports of hypersensitivity reactions that have included fatal or life-threatening instances. Any signs of a rash while using Lamictal should result in the immediate discontinuation of Lamictal until a qualified physician has been consulted.

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