FDA Warns of Lamictal Side Effect: Hemophagocytic Lymphohistiocytosis

FDA Warns of Lamictal Side Effect: Hemophagocytic Lymphohistiocytosis

Lamictal(lamotrigine) is a drug prescribed to those with various seizure disorders. It is also used for adults with mood disorders such as bipolar disorder.

While Lamictal is an effective treatment for these medical conditions, it also comes with a risk of serious side effects. In the past, the biggest concern for pediatric patients was serious skin rashes, including Stevens-Johnson syndrome. But there is now another concern that patients and their family members should be aware of.

The Food and Drug Administration (FDA) released a Drug Safety Communication on April 25, 2018, warning physicians and patients about a serious reaction that can occur with Lamictal use. Patient’s can experience an adverse reaction where the body’s immune system is activated, causing severe inflammation. If not timely treated, this inflammation can lead to hospitalization and even death. Per the FDA, information about this serious reaction will be added to Lamictal labeling moving forward.

Hemophagocytic lymphohistiocytosis  is the name of the severe immune reaction that Lamictal can cause. This uncontrolled response starts out as a fever above 101 degrees. When persistent, it can cause serious damage to the lungs, liver, kidneys and other organs.

Because of this, prompt identification and treatment of hemophagocytic lymphohistiocytosis is essential to prevent mortality. Because symptoms of rashes and fever are not specific, they may be confused with other immune system disorders, complicating accurate diagnosis of this rare condition.

Hemophagocytic lymphohistiocytosis can occur days or weeks after starting Lamictal treatment. It is important that Lamictal users inform their doctors if he or she develops symptoms of this condition, which can include:

  • Fever above 101 degrees
  • Persistent pain in the upper stomach region
  • Skin rashes
  • Yellowing of skin or eyes
  • Swollen lymph nodes
  • Unusual bleeding
  • And neurological changes, such as difficulty walking or seeing

Patient Recommendations

Lamictal has been approved for use by the FDA for 24 years and has proven effective for many patients. Despite this new warning, it is not recommended that patients stop using Lamictal, as this can cause uncontrollable seizures and/or mood swings.

If you experience any of the symptoms of hemophagocytic lymphohistiocytosis listed above, contact your doctor for evaluation. Your doctor will perform blood work and other lab tests to determine diagnosis. A diagnosis of hemophagocytic lymphohistiocytosis requires five of the following symptoms:

  • Fever and rash
  • Enlarged spleen
  • Reduction in the number of blood cells (cytopenia)
  • High levels of blood ferritin
  • High levels of triglycerides
  • Elevated blood levels of CD25
  • Hemophagocytosis
  • Absence of natural killer cells

If you experience at least five of these symptoms, your doctor may recommend stopping Lamictal treatment. Under no circumstances should use stop using Lamictal, unless you are advised to do so by a medical professional.

If you or a loved one used Lamictal and were diagnosed with Hemophagocytic lymphohistiocytosis, contact the Lamictal Side Effect Attorneys of Nadrich & Cohen now for a free and confidential consultation. Call us today at 1-800-718-4658.


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