PvPI Cautions Physicians On Rational Use Of Anti-Inflammatory Drug Nimesulide

Mumbai, 6 Jan 2020:

Despite being banned by the Union health ministry for use in patients below 12 years of age following severe adverse reaction, nimesulide is rampantly being prescribed by scores of physicians across the country to treat children with fever and cold.

There have been several reports of Stevens-Johnson Syndromen (SJS)/toxic epidermal necrolysis (TEN) induced by consumption of nimesulide, a nonsteroidal anti-inflammatory (NSAID) drug with antipyretic and analgesic properties.

SJS/TEN are very serious skin conditions that can happen as a result of illness or as side effects to certain medications. Often, it begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters.

Recently, the Pharmacovigilance Programme of India (PvPI) had issued advisory for the rational use of nimesulide following a case of nimesulide induced Stevens-Johnson Syndrome. In the said case, the drug was inappropriately prescribed in a 10-year-old boy. The patient had no medical history. The indication for tablet nimesulide is used for fever and cold. The therapy given on December 25, 2019 and treatment was discontinued on the next day. The dose used was 100 mg twice a day orally.

The patient had been experiencing Stevens-Johnson Syndrome since December 26, 2019.The two drugs are concomitantly used. The medical practitioner who prescribed nimesulide to the paediatric patient reported adverse event related to the drug to regional pharmacovigilance centre (RPC). The case was reported to PvPI by RPC.

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

The drug has never been approved for use in USA, UK, Canada, Australia, New Zealand, Japan. The government of India had prohibited use of nimesulide in children aged below 12 years in 2011. Pharmabiz