The anticonvulsant medication lamotrigine can cause the rare but serious immune system reaction hemophagocytic lymphohistiocytosis (HLH), the US and Food and Drug Administration said today in a safety communication.
The FDA said a warning about the risk for HLH will be added to the prescribing information on lamotrigine drug labels.
Lamotrigine is used alone or with other medicines to treat seizures in patients age 2 years and older. It is also indicated for maintenance treatment in patients with bipolar disorder to help stave off mood episodes (depression, mania or hypomania, and mixed episodes).
HLH is a hyperinflammatory syndrome that can lead to hospitalization and death, especially if not diagnosed and treated quickly. Diagnosis is often complicated because early signs and symptoms, such as fever and rash, are not specific, the FDA notes. HLH may also be confused with other serious immune-related adverse reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS).
Elevated levels of triglycerides or low blood levels of fibrinogen;
Hemophagocytosis identified through bone marrow, spleen, or lymph node biopsy;
Elevated blood levels of CD25 showing prolonged immune cell activation.
Healthcare professionals are encouraged to report adverse events related to use of lamotrigine to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
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Cite this: FDA: Lamotrigine Tied to Rare, Serious Immune System Reaction - Medscape - Apr 25, 2018.
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