Controversial NSAID nimesulide now banned in China for children below 12

The Chinese regulator, the State Food and Drug Administration (SFDA) has issued a notice banning the use of nimesulide, an anti-inflammatory drug made by Switzerland’s Helsinn, for children under the age of 12, considering potential side-effects such as liver and kidney damage, reports the Xinhau news agency. The drug entered the Chinese markets in 1997.

Nimesulide is a non-steroidal anti-inflammatory (NSAID) drug that first became available in Italy in 1985. It is now used in more than 50 countries and regions. However, earlier this year, India’s Union Ministry of Health and Family Welfare decided to ban the pediatric use of nimesulide suspension, after 10 years of concerns about the drug’s safety. While the drug is banned and, in fact, not marketed in most countries, the sub-committee of the Indian government’s chief advisory body, the Drug Technical Advisory Board (DTAB), recommended banning the drug.

According to the SFDA, while common adverse reactions to the drug include vomiting and stomach, domestic and overseas statistics indicate that more severe issues are related to the drug, such as blood coagulation disorders, decreased white blood cells and damage to liver and kidney. Previously, the SFDA only prevented the use of the drug among children one year old or younger.