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 May 13, 2005
Anti-epileptic Kits Recalled for Dosing Error
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GlaxoSmithKline said it is recalling 39 lots of its Lamictal starter kits after some packs were found to contain incorrect dosing strengths of the anti-epileptic drug.

The dose for the fifth week of therapy is supposed to be 100 mg., not the 25 mg. indicated in some of the kits, the company said. Patients who vary the recommended dose by this degree are at risk of contracting Stevens-Johnson syndrome, a deadly allergic-like reaction, the company said.

Lamictal (lamotrigine) already contains a U.S. Food and Drug Administration "black box" warning about Stevens-Johnson syndrome, indicating that recommended dosing directions must be followed carefully.

The company estimates that about 100,000 Lamictal starter kits may be subject to this recall.


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