Patients who experience a rash from Lamictal, a seizure and bipolar drug, may be at risk for hemophagocytic lymphohistiocytosis, a dangerous immune reaction.

On April 25, the U.S. Food and Drug Administration (FDA) released a safety warning to consumers. The alert cautioned that patients who develop a rash from Lamictal may be at risk for a serious, life threatening immune reaction known as hemophagocytic lymphohistiocytosis (HLH).

“Healthcare professionals should be aware that prompt recognition and early treatment is important for improving HLH outcomes and decreasing mortality. Diagnosis is often complicated because early signs and symptoms such as fever and rash are not specific,” the safety alert states.

“HLH may also be confused with other serious immune-related adverse reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).”

What Is Lamictal?

Lamictal (lamotrigine) is a medicine prescribed to treat seizures in patients older than two. The drug is also prescribed as a maintenance treatment for bipolar disorder. The drug can help delay mood episodes such as depression, mania, or hypomania.

However, reports received by the FDA have linked a seemingly innocent rash from Lamictal to a dangerous immune reaction known as hemophagocytic lymphohistiocytosis (HLH). HLH causes an uncontrolled response by the immune system and typically presents with a high fever and a rash, although these symptoms are not always present.

Other symptoms of HLH include enlarged spleen, cytopenias, elevated levels of triglycerides or low blood levels of fibrinogen, high levels of blood ferritin, hemophagocytosis, decreased or absent Natural Killer (NK) Cell activity, and elevated blood levels of CD25 showing prolonged immune cell activation. If a patient presents with at least five of the above symptoms during Lamictal treatment, the FDA recommends starting treatment for HLH.

Other symptoms mentioned by the FDA include enlarged liver, swollen lymph nodes, skin rashes, yellow skin or eyes, unusual bleeding, or nervous system problems including seizures, trouble walking, and difficulty seeing.

HLH can be a serious condition involving severe inflammation leading to organ damage and death, especially if not properly treated. The FDA encouraged medical professionals to “advise patients to seek immediate medical attention if they experience symptoms of HLH during lamotrigine treatment”.

“Patients or their caregivers should contact their health care professionals right away if they experience any symptom of HLH while taking lamotrigine. HLH can occur within days to weeks after starting treatment,” the safety alert states.

Although the FDA encourages vigilance by both patients and medical professionals, the safety alert reminds that the drug should not be stopped without physician supervision. Suddenly stopping treatment with Lamictal “can lead to uncontrolled seizures, or new or worsening mental health problems”.

Following the safety alert, the FDA required GlaxoSmithKline, the drug’s manufacturer, to include a new warning label. However, new warnings do not benefit people who have already experienced HLH from Lamictal.

If your or a loved one developed a rash from Lamictal which later turned out to be a dangerous condition, you may qualify for legal action against the drug’s manufacturer. A Lamictal lawsuit could help recover compensation for medical expenses, pain and suffering, wrongful death, and more.