FDA Warns of Rare Lamictal Reaction

FDA says that the drug lamotrigine (GlaxoSmithKline’s Lamictal), indicated for seizures and bipolar disorder, can cause a rare but very serious reaction known as hemophagocytic lymphohistiocytosis (HLH) that excessively activates the body’s infection-fighting immune system. An agency drug safety notice says the reaction can cause severe inflammation throughout the body and lead to hospitalization and death, especially if it is not diagnosed and treated quickly. FDA says it is requiring that the drug’s labeling be changed to include a Warning about the risk.

According to the notice, HLH typically presents as a persistent fever and can lead to severe problems with blood cells and organs throughout the body such as the liver, kidneys, and lungs. “Healthcare professionals should be aware that prompt recognition and early treatment is important for improving HLH outcomes and decreasing mortality,” FDA says.