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FDA Reports a Life-Threatening Immune Reaction to Lamotrigine: What You Should Know

A rare but life-threatening immune reaction in response to lamotrigine (Lamictal) requires prompt diagnosis and treatment, according to a recent alert from the U.S. Food and Drug Administration (FDA).   On April 25, the FDA issued what it calls a “drug safety communication” about the risk of a condition so rare that few neurologists have heard of it: hemophagocytic lymphohistiocytosis (HLH), a systematic immune reaction that can result in organ failure and death if not quickly treated.   Just eight such cases associated with lamotrigine, including one death, are known by the FDA to have occurred since the drug was first approved in 1994 as a treatment for epilepsy. Since then, it has also been approved for bipolar disorder, and is now increasingly prescribed off-label...

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