The Food and Drug Administration has issue a warning about the risk of serious and potentially deadly side effects associated with the seizure and bipolar disorder drug Lamictal (lamotrigine). According to the FDA warning, patients taking Lamictal may experience an immune system response that can cause severe inflammation throughout the body, leading to hospitalization or death.
Lamictal was approved by the FDA in 1994. The drug is prescribed alone or in combination with other medications to treat patients with seizure disorders who are older than 2 years old. Lamictal is also prescribed to patients with bipolar disorder to delay the onset of mood episodes, including depression, mania, and hypomania. The drug is currently sold both under the brand name Lamictal as well as in generic versions.
The immune system response that has been observed in patients taking Lamictal is known as hemophagocytic lymphohistiocytosis (HLH). After receiving reports of patients who developed HLH while taking Lamictal, the FDA ordered the manufacturers of this medication to add a warning label about the risk of the condition.
In patients who develop HLH, the condition causes uncontrolled immune system response due to their body’s reaction to Lamictal. HLH may occur days or even weeks after starting treatment with Lamictal.
Symptoms of HLH may include:
- Fever that won’t go away (usually above 101°F)
- Enlarged spleen or liver
- Yellow eyes or skin (jaundice)
- Nervous system problems, including seizures, vision problems, or trouble walking
Because patients who have developed HLH may experience serious blood cell problems or problems with the organs – including the liver, kidneys, or lungs – the FDA advises patients who are taking Lamictal and develop possible symptoms of HLH to seek medical attention as soon as possible. Doctors who are treating Lamictal users with signs of HLH are urged to look for the eight symptoms of the condition by performing tests. These symptoms are listed on the FDA safety alert regarding Lamictal and HLH, which is available on the agency’s website.
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