Aimed at ensuring safety of patients using Lamotrigine, prescribed for treating bipolar disorder and epilepsy, the Central Drugs Standard Control Organisation (CDSCO) has directed all State drug regulators to ask drug makers to insert warnings about the possible ‘immune system reaction’.
In an alert issued recently, the CDSCO has noted that ‘hemophagocytic lymphohistiocytosis (HLH)’ reaction should be as part of their information leaflets for patients. HLH is a rare condition in which the body makes too many cells to fight infection, leading to symptoms of fever, enlarged liver or spleen and neurological abnormalities.
Drug Controller General of India V.G. Somani noted that the safety issue on Lamotrigine was deliberated in the subject expert committee on neurology and psychiatry, on November 27.
“After detailed deliberation, the committee recommended that the warning of immune system reaction called HLH should be mentioned in the package insert of the drug marketed across the country.”
Lamotrigine is sold in India under more than 20 brand names and the direction comes after the U.S. Food and Drug Administration (FDA) flagged some concerns about the drug in 2018.
The CDSCO, India’s apex drug regulator, had started an investigation into the side-effects of Lamotrigine immediately after this alert.
The U.S. FDA had released a drug safety communication which said the drug Lamotrigine for seizures and bipolar disorder, can cause a rare but very serious reaction. This can cause severe inflammation throughout the body and lead to hospitalisation and death, especially if the reaction is not diagnosed and treated quickly.
