Stop prescribing Nimesulide to paediatric patients below 12 years: PvPI advisory to doctors

New Delhi: Raising an alert to avoid adverse reactions related to the use of Nimesulide in certain pediatric patients, the Pharmacovigilance Programme of India (PvPI) has issued an advisory, directing medical practitioners in India to stop prescribing the drug to children under the age of 12 years and promote rational use of medicines.

The direction came following a serious case of Nimesulide inducing Stevens-Johnson Syndrome in a male child. This Syndrome is a rare and serious disorder of the skin and mucous membranes.

As per various media accounts, the said case concerned a 10-year-old kid, who was inappropriately prescribed the drug, indicated for treating fever and cold. The dose was used in 100 mg strength, twice a day orally. The therapy was taken on December 25 2019. However, it was immediately discontinued on December 26 after the patient experienced Stevens-Johnson Syndrome. The patient had no medical history.

The adverse event related to the drug was reported to the Regional Pharmacovigilance Centre (RPC) by the doctor who had prescribed the drug to the paediatric patient. The case was further reported to PvPI by RPC.

Alerted by adverse event related to Nimesulide, PvPI recently prompted healthcare professionals to take all necessary precautions in order to avoid such mishappenings and to promote rational use of medicines.

Prior to this, in 2017, the Central government had banned the fixed-dose combination of Nimesulide + Levocetirizine announcing that the drug fixed-dose combination of Nimesulide + Levocetirizine was not rational. The Government had found it is necessary and expedient in public interest to regulate by way of prohibition, the manufacture for sale, sale and distribution for human use of the said drug in the country.

Also Read: Central Govt bans Nimesulide, Levocetirizine combination

Moreover, in February 2011, the Ministry of Health and Family Welfare (MoHFW) had already banned the use of Nimesulide in patients below 12 years of age following severe adverse reaction. The drug has also not been approved for use in USA, UK, Canada, Australia, New Zealand and Japan.

Various cases of Stevens-Johnson Syndrome (SJS)/toxic epidermal necrolysis (TEN) induced by consumption of Nimesulide have been reported in the past.

Nimesulide is a nonsteroidal anti-inflammatory drug with pain medication and fever-reducing properties. Its approved indications are the treatment of acute pain, the symptomatic treatment of osteoarthritis, and primary dysmenorrhoea in adolescents and adults above 12 years old.

Also Read: Prescribing Nimesulide- Beware of these combinations