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. Incidance of occurance of meningitis in patitents 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 childrens 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 cout 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 : –
6-(2,3-dichlorophenyl)-1,2,4-triazine-3,5-diamine

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.

=======================================================================
What is What is 510(k) Clearances ?
What is 510(k) Clearances, Premarket Notification for medical devices – PMN or 510(k)

Antibiotic Definition and classification

Antibiotic resitance and Drug resistance mechanism

Antioxidants food suppliments

Vitamin D Details on FDA cautions on accurate dosage of Vitamin D

What is an antibody? what is monoclonal and polyclonal antibodies?

Enzyme linked immunosorbent assay ELISA

Raido Immuno assay

http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.

http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html

Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in

pharmaceutical industry

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing

Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coefficient of a disinfectant

Sterility testing

Cleen Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Controlling Pyrogens in injectable dosage forms