Pharmacovigilance Programme of India (PvPI) urges healthcare professionals to take require measures and do not prescribe Nimesulide for children under 12 years of age. PvPI urges to spread awareness among healthcare professionals to take all necessary precautions in order to avoid such mishappenings and to promote rational use of medicines.
PvPI has received a serious case of Nimesulide induced Stevens-Johnson Syndrome in a child. Nimesulide was inappropriately prescribed in a 10-year-old male child who induced Stevens-Johnson Syndrome.
Stevens-Johnson syndrome is a type IV hypersensitivity reaction that typically involves the skin and the mucous membranes. Generally, it begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters. It requires emergency treatment aims to eliminate the underlying cause and control symptoms and complications.
In India, the use of Nimesulide has already been banned in patients below 12 years of age by the Ministry of Health and Family Welfare since February 2011. 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.
The mission of PvPI is to safeguard the health of the Indian population by ensuring that the benefit of use of medicine outweighs the risks associated with its use. Since there exist considerable social and economic consequences of adverse drug reactions and the positive benefit/cost ratio of implementing appropriate risk management - there is a need to engage healthcare professionals and the public at large, in a well structured programme to build synergies for monitoring adverse drug reactions in the country.
PvPI recommend all healthcare professionals to take a note of this and spread it among healthcare professionals.
