Do not prescribe Nimesulide for kids below 12 yrs: Pharma vigilance body
| Date :08-Jan-2020 |
By Rajendra Diwe :
PHARMACOVIGILANCE Programme of India (PvPI) has directed medical practitioners across the country not to prescribe Nimesulide for children under 12 years of age. PvPI has appealed the doctors to take all necessary precautions to avoid such mishappenings and to promote rational use of medicines. PvPI has issued the advisory to medical practitioners after receiving a serious case of Nimesulide induced Steven’s-Johnson Syndrome in a child. Nimesulide was inappropriately prescribed for a 10-year-old male child who contracted Steven’s-Johnson Syndrome, a rare and serious disorder of skin and mucous membranes. It is usually a reaction to a medication or an infection. 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 dose used was 100 mg twice a day orally. Therapy was given on December 25, 2019 and treatment was discontinued the next day. The patient had been experiencing Steven’s-Johnson Syndrome since December 26, 2019. 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. 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. PvPI recommended all healthcare professionals to take a note of this and spread it among healthcare professionals. Nimesulide 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. 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 Steven’s-Johnson Syndrome (SJS)/toxic epidermal necrolysis (TEN) induced by consumption of Nimesulide, a nonsteroidal anti-inflammatory (NSAID) drug with antipyretic and analgesic properties.
What is Steven’s-Johnson syndrome Steven’s-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.