Safety Alert: Serious immune system reaction with seizure and mental health medicine Lamotrigine

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.

Lamotrigine is used alone or with other medicines to treat seizures in patients two years and older. It may also be used as maintenance treatment in patients with bipolar disorder to help delay the occurrence of mood episodes such as depression, mania, or hypomania. 

In a safety alert communication issued by the Central Drugs Standard Control Organisation (CDSCO), 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.

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.

Prior to this on 25 April 2018, the US FDA had released a drug safety communication that read: “The Food and Drug Administration (FDA) is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly.”

In the 24 years since lamotrigine’s 1994 approval, FDA identified eight cases worldwide of confirmed or suspected HLH associated with the medicine in children and adults.