Monday, August 16, 2010

Lamictal risk of Aseptic Meningitis

Aseptic Meningitis Risk with Use of AntiSeizure Drug Lamictal.

The United .States F DA on 12th Aug 2010 has issued a press release where they have warned general public and healthcare professionals about possible risk of aseptic meningitis as an untoward effect of Lamictal (lamotrigine) ,they said, that the drug Lamictal (lamotrigine) is approved to treat seizures and bipolar disorder, can cause aseptic meningitis. Aseptic meningitis an inflammation of the protective membranes (meninges) that cover the brain and spinal cord not caused by bacterial infection.
They said that US FDA is working with the drug’s manufacturer, GlaxoSmithKline, to update the prescribing information and patient medication guide to include this risk.
What is meningitis:
meningitis is a condition where a sever inflammation of membrane covering brain and spinal cord occur, mostly the bacterial and viral infections are measure causes of meningitis , it can result in brain damage leading to conditions related to brain damage like hearing loss , learning disabilities.
Most sever form of meningitis is bacterial meningitis caused by Haemophilus influenzae type b (Hib) ,( vaccine is available against it ) and Streptococcus pneumoniae and Neisseria meningitides
Aseptic meningitis is caused by viral infections , toxic agents ,drugs and vaccines , certain autoimmune diseases , and certain medications, including Lamictal
Symptoms can include headache, fever, chills, nausea, vomiting, stiff neck and sensitivity to light. Hospitalization may be required.

In suspected cases of meningitis, the underlying cause must be rapidly diagnosed so that treatment can be promptly initiated. Discontinuation of Lamictal should be considered if no other clear cause of meningitis is identified. Incidence of occurrence of meningitis in patients on Lamictal is rare but serious.
US FDA said in their press release that , “they became aware of the association between Lamictal and aseptic meningitis through routine adverse event monitoring and communications with the drug’s manufacturer.”

Since approval of drug lamactile about 40 cases of aseptic meningitis were reported which were seen in patients taking Lamictal , symptoms observed form one to 42 days after starting drug lamactile
35 patients were required to hospitalize , and in most of cases condition symptoms disappeared after discontinuation of drug lamactil , and in 15 cases symptoms were sever and patients regained symptoms again after restarting drug lamactil.

Lamactile is used in children of age two years and old for treating seizures and in adults bipolar disorder. Use of lamactle can cause aseptic meningitis

US FDA SAID they are revising the Warnings and Precautions section of the drug label and the patient Medication Guide to include information about this risk.
Observation of lamactile associated meningitis were also characterized by CSF analysis where a mild to moderate pleocytocic , normal glucose level and mild to moderate increase in protein levels , and CSF blood cell count with higher value of neutrofile were observed in about 25 cases, increased count of lymphocytes in one third of the cases reported.

Also some patients also had underlying causes like systemic lupus erythematosus or other autoimmune diseases, and some patients were found with onset of signs and symptoms of involvement of other organs (predominantly hepatic and renal involvement , which may indicate Lamictal-associated meningitis were part of a hypersensitivity or generalized drug reaction.

Lamactile : is a drug containing Lamotrigine
(IUPAC) name : -

Mode of action of Lamotrigine :
Lamotrigine is considered to inhibit voltage sensitive sodium chanels bring about stabilization of neuronal membranes and controls release of presynaptic release of release of excitatory amino acid like aspartate and glutamate.

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