On April 25, 2018 the U.S. Food & Drug Administration issued an urgent Safety Communication warning patients and physicians that the medication Lamictal had been linked to a rare but very serious reaction that excessively activates the body’s infection-fighting immune system.
This reaction is called hemophagocytic lymphohistiocytosis (HLH), which causes severe inflammation throughout ones body and can lead to hospitalization and death.
Lamictal (Lamotrigine) was approved by the U.S. Food and Drug Administration in 1994. It was initially developed as an antiepileptic prescription medication to treat seizures in children ages two and older. Other uses have been in primary or secondary tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome.
Lamictal was later found to be useful in treating adult patients with bipolar type I disorder. Lamictal has undergone multiple warning label revisions due to the occurrence of serious side effects and complications.
Stevens-Johnson Syndrome (SJS), erythema multiforme major, aseptic meningitis, toxic epidermal necrolysis (TEN) and now hemophagocytic lymphohistiocytosis (HLH) are among some of the serious side effects linked to Lamictal.
In addition, the FDA released a statement in 2006 that babies exposed to Lamictal in the first three months of pregnancy have a high chance of developing a cleft palate or lip.
2018 FDA Warning of Hemophagocytic Lymphohistiocytosis
The FDA issued a warning on April 25, 2018 that consumers taking Lamictal should immediately contact their physician if they develop a fever or rash after taking the medication. They advised a risk of hemophagocytic lymphohistiocytosis (HLH) be added to labels on Lamictal medications.
What is Hemophagocytic Lymphohistiocytosis?
HLH is a rare but serious immune system disorder which causes severe inflammation throughout the body. If left untreated it can result in death.
According to Cincinnati Children’s Hospital, HLH can be challenging to diagnose because the initial symptoms may mimic other problems such as common infections. Signs and symptoms of HLH may include:
- Persistent fevers
- Enlarged liver
- Enlarged spleen
- Enlarged lymph nodes
- Low platelets
- Low white blood cells
- Liver failure
- Respiratory issues (coughing, respiratory distress)
- Altered mental functions
If you develop any of the above side effects it is important you contact your doctor immediately to rule out the possibility of serious complications.
Meet Max, and learn about the rare immune disorder called hemophagocytic lymphohistiocytosis, better known as HLH.