US FDA issues warning on anti-seizure drug
Health officials in the United States have issued a warning to doctors and patients suggesting that an anti-seizure drug Lamictal marketed by GlaxoSmithKline might lead to severe side effects in children and adults suffering from bipolar disorders.
Lamotrigine, marketed as Lamictal, is an anti-convulsion drug used for treating epilepsy and bipolar disorder. It is used in partial seizures, primary and secondary tonic-colonic seizures and others associated with the Lennox-Gastaut syndrome.
The Food and Drug Administration (FDA) has warned that doses of Lamictal could result in aseptic meningitis or a condition where it can cause a rare inflammation of the brain and spinal cord.
The drug is currently sold in three forms across the United States - an orally disintegrating tablet (Lamictal ODT), as an extended release product (Lamictal XR), and also as a chewable, dispersible tablet (Lamictal CD).
FDA officials said in a statement late last week that they were looking into the matter and studying the warnings and precautions to be carried on the drug labels and patient medication guidelines. Following this, they will bring out a new set of standard listing out the risk factors of the drug.
Meanwhile, healthcare professionals have suggested that if patients suspect meningitis, they should get themselves for other causes for the disease and seek appropriate treatment.
In a press release last week, the FDA said it had received reports of 40 cases of aseptic meningitis between the approval of Lamictal in 1994 and end of last year of which 35 need hospitalizations. It further said that patients who developed acute meningitis after consuming Lamotrigine had been identified with systemic lupus erythematous and other autoimmune diseases.