Other safety alerts
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| The United States: FDA Drug Safety Communication: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal) |
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The US Food and Drug Administration (FDA) is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. As a result, FDA is requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels.
The immune system reaction, called hemophagocytic lymphohistiocytosis (HLH), causes an uncontrolled response by the immune system. HLH typically presents as a persistent fever, usually greater than 101°F, and it 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. Diagnosis is often complicated because early signs and symptoms such as fever and rash are not specific. HLH may also be confused with other serious immune-related adverse reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Healthcare professionals should evaluate patients who develop fever or rash promptly, and discontinue lamotrigine if HLH or another serious immune-related adverse reaction is suspected and an alternative etiology for the signs and symptoms cannot be established. Healthcare professionals should also advise patients to seek immediate medical attention if they experience symptoms of HLH during lamotrigine treatment. A diagnosis of HLH can be established if a patient has at least five of the following eight signs or symptoms:
- fever and rash
- enlarged spleen
- cytopenias
- elevated levels of triglycerides or low blood levels of fibrinogen
- high levels of blood ferritin
- hemophagocytosis identified through bone marrow, spleen, or lymph node biopsy
- decreased or absent Natural Killer (NK) Cell activity
- elevated blood levels of CD25 showing prolonged immune cell activation
Patients or their caregivers should contact their healthcare professionals right away if they experience any symptom of HLH while taking lamotrigine. HLH can occur within days to weeks after starting treatment. A physical examination and specific laboratory blood tests and other evaluations are used to diagnose HLH. Patients should not stop taking lamotrigine without talking to their healthcare professionals first as doing so can cause serious problems. Signs and symptoms of HLH include but are not limited to:
- fever
- enlarged liver; symptoms may include pain, tenderness, or unusual swelling over the liver area in the upper right belly
- swollen lymph nodes
- skin rashes
- yellow skin or eyes
- unusual bleeding
- nervous system problems, including seizures, trouble walking, difficulty seeing, or other visual disturbances
In the 24 years since lamotrigine’s 1994 approval, FDA identified eight cases worldwide of confirmed or suspected HLH associated with the medicine in children and adults. This number includes only reports submitted to FDA and found in the medical literature, so there are likely additional cases about which FDA is unaware. FDA determined there was reasonable evidence that lamotrigine was the cause of HLH in these eight cases based on the timing of events and the order in which they occurred. The patients in these cases required hospitalization and received drug and other medical treatments, with one dying.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm605470.htm
In Hong Kong, there are 22 registered pharmaceutical products containing lamotrigine, and are prescription-only medicines. So far, the Department of Health (DH) has received one case of adverse drug reaction related to lamotrigine, but it was not related to HLH. In light of the above FDA’s announcement, letters to inform local healthcare professionals will be issued and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Thursday, Apr 26, 2018
Issued at HKT 15:00
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