New Delhi: Lamotrigine, a widely-sold medicine to treat bipolar disorder and seizures in epileptic patients will now have to carry a side-effect warning of possible ‘immune system reaction’ on its packages.
In a safety alert communication issued on 16 December by the Central Drugs Standard Control Organisation (CDSCO), a copy of has been accessed by ThePrint, the government has asked all state drug regulators to inform companies manufacturing Lamotrigine to insert warnings about ‘hemophagocytic lymphohistiocytosis (HLH)’ reaction as part of their leaflets or packaging inserts.
HLH is a rare but very serious condition in which the body makes too many cells to fight infection, leading to symptoms of fever, enlarged liver or spleen and neurological abnormalities.
The alert, signed by Drug Controller General of India V.G. Somani, reads: “The safety issue on Lamotrigine was deliberated in the subject expert committee, neurology and psychiatry, on 27 November.
“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 such as Lamitor, Lametec, Lamosyn and Lamez, which are manufactured by Torrent Pharmaceuticals, Cipla, Sun Pharmaceuticals and Intas Pharmaceuticals, respectively.
Some other firms that manufacture this drug are GlaxoSmithKline, Ipca Laboratories, Alkem and Emcure Pharmaceuticals.
When is the drug used
Lamotrigine is an anti-convulsant medication to treat seizures in epileptic patients. It is also used to control extreme mood swings in bipolar disorder — a medical condition that results in unusual shifts of mood, energy levels and the ability to carry out day-to-day tasks.
Lamotrigine works by restoring a balance of certain natural substances in the brain.
According to data by AIOCD-AWACS, a health research firm, Lamotrigine had registered an annual turnover of Rs 93 crore in 2019, posting a growth of more than 10 per cent in its sales over 2018 in India.
US FDA’s safety alert
The CDSCO, India’s apex drug regulator, had started an investigation into the side-effects of Lamotrigine after the US Food and Drug Administration (FDS) flagged some concerns about the drug in 2018.
On 25 April 2018, the US FDA had released a drug safety communication that read: “…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.”
In its safety alert communication, therefore, the CDSCO referred to FDA’s concerns: “According to US FDA, the immune system reaction called HLH causes and uncontrolled response by the immune system. HLH typically presents a persistent fever, usually greater than 101 degree, farenheit. And it can lead to severe problems with blood cells and organs throughout the body such as liver, kidney and lungs.”
Marked to the zonal and sub-zonal offices of CDSCO across India, the alert orders drug inspectors “to direct manufacturers under their jurisdiction to mention the warning of HLH in the package alert or the promotional literature of the drug”.