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FDA Drug Safety Podcast: Aseptic meningitis associated with use of Lamictal

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On August 12, 2010 the Food and Drug Administration issued a Drug Safety Communication titled: Aseptic meningitis associated with use of Lamictal.

I am Yolanda Fultz-Morris from F-D-A's Center for Drug Evaluation and Research.

FDA is informing the public that Lamictal, also known as lamotrigine, a medication commonly used for seizures in children two years and older, and bipolar disorder in adults, can cause aseptic meningitis.

Meningitis is an inflammation of the protective membranes that cover the brain and spinal cord. Causes of aseptic meningitis include viruses and other non-bacterial infections, toxic agents, some vaccines, malignancy, and certain medications, including Lamictal.

Symptoms of meningitis may include headache, fever, stiff neck, nausea, vomiting, rash, and sensitivity to light.

Patients who experience headache, fever, chills, nausea, vomiting, stiff neck, rash, abnormal sensitivity to light, drowsiness, or confusion while taking Lamictal should contact their healthcare professional right away. In cases of meningitis, it is important to rapidly diagnose the underlying cause so that treatment can be promptly initiated.

 

 

Lamictal is also sold as an oral tablet known as Lamictal ODT, a chewable tablet, Lamictal CD, and as an extended release product Lamictal XR. FDA is revising the Warnings and Precautions section of the drug label and the patient Medication Guide to include information about the risk of aseptic meningitis.

Patients and consumers who use Lamictal should be aware of the following:

Aseptic meningitis is a rare, but serious side effect of Lamictal.
 

Contact your healthcare professional right away if you experience headache, fever, chills, nausea, vomiting, stiff neck, rash, abnormal sensitivity to light, drowsiness, or confusion while taking Lamictal.
 

Read the Medication Guide given to you each time you receive your Lamictal. It will explain the risks and benefits of Lamictal.
 

Report any side effects you experience to the FDA MedWatch program, using the information provided at the end of this announcement.
 

FDA urges healthcare providers and patients to report any adverse events or side effects that may be associated with the use of products containing lamictal to us at the FDA's MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at W-W-W dot F-D-A dot GOV slash M-E-D-W-A-T-C-H.

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash D-R-U-G-S.

 

 

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