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Lamictal is an anti-seizure medication that has been linked to a life-threatening immune disease. It also carries a “Black Box” warning label about Stevens-Johnson Syndrome (SJS), a rare but life-threatening allergic skin rash.

Lamictal Linked to Immune Disease

In April 2018, the FDA updated the label on Lamictal to warn that it can cause a serious immune system disease called Hemophagocytic lymphohistiocytosis (HLH). It excessively activates the body’s infection-fighting immune system immune. This can cause fever, severe inflammation all over the body, hospitalization, and death

What is Hemophagocytic Lymphohistiocytosis (HLH)?

Hemophagocytic Lymphohistiocytosis (HLH) is a disease in which the body makes too many infection-fighting immune cells. The number of cells increases uncontrollably. HLH often causes a persistent fever over 101°F, and it can lead to severe problems with blood cells and organs such as the liver, kidneys, and lungs.

What is Lamictal?

Lamictal (lamotrigine) is an anti-seizure drug that is used in people with epilepsy and mood disorders. It has been marketed by GlaxoSmithKline (GSK) since 1994, and is now available as a generic. Lamictal is also sold as an orally disintegrating tablet (Lamictal ODT), a chewable tablet (Lamictal CD), and an extended-release product (Lamictal XR).

Lamictal and Stevens-Johnson Syndrome (SJS)

Lamictal carries a prominent Boxed Warning about the risk of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which are estimated to affect approximately 1 in 1,000 adults or 1 in 50 children. Nearly all cases of SJS occur within 2 to 8 weeks of treatment with Lamictal. However, isolated cases have been reported after 6 months. Lamictal should be discontinued at the first sign of a rash unless the rash is clearly not drug-related.

What is SJS?

Stevens-Johnson Syndrome is an allergic reaction to Lamictal that can cause a severe, life-threatening skin rash. SJS causes the top layer of skin (epidermis) to detach from the lower layers and peel off the body in large sheets. It also causes inflammation of the mucous membranes (eyes, mouth, genitals, etc.). The condition is extremely painful, disfiguring, and can lead to deadly complications.

Symptoms of SJS/TEN

  • Flu-like illness
  • Persistent fever
  • Skin rash that spreads all over the body
  • Fluid-filled blisters
  • Inflammation of mucous membranes
  • Loss of skin
  • Infections
  • Vision loss or blindness
  • Organ damage
  • Genital scarring
  • Skin disfigurement
  • Pneumonia (lung infection)
  • Organ damage or failure
  • Death

FDA Warning for Lamictal and Aseptic Meningitis

In August 2010, the FDA issued a Safety Warning and updated the label on Lamictal to include aseptic meningitis, a rare but serious side effect involving inflammation of the protective membranes (meninges) that cover the brain and spinal cord. It is likely caused by an allergic reaction to Lamictal. From December 1994 to November 2009, 40 cases of aseptic meningitis occurred in patients on Lamictal. Symptoms occurred an average of 16 days after starting Lamictal. One patient died, 35 patients were hospitalized, and some patients had kidney or liver impairment. In 15 patients who re-started Lamictal, severe symptoms occurred within 30 minutes to 24 hours.