Antiepileptic drug Lamotrigine will have to carry warning for hemophagocytic lymphohistiocytosis: CDSCO

New Delhi: Commonly used bipolar disorder and epilepsy bipolar drug Lamotrigine will have to now carry mandatory safety alert in its leaflet regarding the immune system reaction as the apex regulator Central Drugs Standard Control Organisation (CDSCO) has cleared a decision to this effect

Lamotrigine is used alone or with other medications to prevent and control seizures. It may also be used to help prevent the extreme mood swings of bipolar disorder in adults. It is known as an anticonvulsant or antiepileptic drug. It is thought to work by restoring the balance of certain natural substances in the brain. This drug is not approved for use in children younger than 2 years due to an increased risk of side effects (such as infections).

Hemophagocytic lymphohistiocytosis (HLH) is a condition in which the body makes too many activated immune cells (macrophages and lymphocytes ). People with HLH usually develop symptoms within the first months or years of life. Prompt recognition of HLH is important as severe inflammation can lead to multi-organ failure resulting in hospitalization and death.

Earlier in April 2018, Food and Drug Administration also issued the safety alerts regarding the same drug. According to the FDA, 8 cases of confirmed or suspected HLH associated with lamotrigine have been reported worldwide (2 in the US). All of these cases were reported to have serious outcomes, with 1 reported death.

Read also: FDA: Lamotrigine has life threatening side effects

This matter was also then brought to the notice of CDSCO SEC. The SEC (Neurology and Psychiatry) deliberated on this matter and made the necessary recommendations in its 53rd meeting held on 27.11.2019 at CDSCO HQ New Delhi. The committee in its decision noted

The committee deliberated the USFDA warning of serious immune system reaction with seizure and mental health medicine lamotrigine published in USFDA website on 25.04.2018.

After detailed deliberation, the committee recommended that the immune system reaction called hemophagocytic lymphohistiocytosis (HLH) should be mentioned in the package insert leaflet of the drug lamotrigine marked in the country

The apex drug regulator, Central Drugs Standard Control Organisation (CDSCO) has then directed state regulators noting that the manufacturers' drug lamotrigine will now have to carry to of the safety alerts regarding the immune system reaction associated with the drug Lamotrigine.

All the state controllers were ordered to guide the manufactures of the drug in this regard.

Read also: Study finds lamotrigine to be safe during pregnancy