U.S. FDA Releases Safety Communication for Lamotrigine
April 24, 2018 – The U.S. FDA has warned that lamotrigine, available in generic forms and under the brand name Lamictil®, may in rare cases cause a life-threatening, uncontrolled immune response known as hemophagocytic lymphohistiocytosis (HLH).
While often a genetic disorder, HLH can have non-genetic causes (acquired HLH). The condition can be characterized by prolonged immune cell activation, enlargement of the spleen, destruction of blood cells, high blood iron levels, fever, and various other difficulties. Prognosis may be poor, depending on the severity and origin of the disease. Left untreated, HLH is fatal, as prolonged and widespread inflammation can lead to multiple organ failure.
Lamotrigine is indicated to treat bipolar disorder and seizures. All forms of the drug will now carry a black box warning regarding the risk of life-threatening HLH. Patients and healthcare providers should be diligent in recognizing early signs of HLH, including rash and fever, as early identification and treatment are vital. In some cases, rash or fever may indicate other serious side effects, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Although confirmed instances of HLH as a side effect of lamotrigine are rare (just eight known cases over the span of 24 years), the FDA judged the risk sufficient to issue a safety communication. Any adverse events noted while using lamotrigine should be reported to the FDA’s MedWatch program.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.