China bans Nimesulide for children below 12 years
China's drug administration authority has banned the use of anti-inflammatory drug Nimesulide for children under the age of 12 years on grounds that it has potential to damage liver and kidney.world Updated: May 21, 2011 15:49 IST
China's drug administration authority has banned the use of anti-inflammatory drug Nimesulide for children under the age of 12 years on grounds that it has potential to damage liver and kidney.
Nimesulide is a non-steroidal anti-inflammatory drug that first became available in Italy in 1985. It is now used in more than 50 countries and regions.
The drug entered Chinese markets in 1997.
According to China's State Food and Drug Administration (SFDA) while common adverse reactions to the drug include vomiting and stomach ache, 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.
Also on Friday, the SFDA ordered the suspension of the production, sales and use of Duxil (almitrine and raubasine compound) due to its "unobvious" efficacy.
According to the SFDA, clinical research found "little" evidence proving the drug effectively improves the cognitive ability for patients suffering vascular cognitive impairment.
The drug was supposed to treat symptoms related to cognition and sensory nerve damage.
The moves came after a two-month nationwide campaign was launched earlier this month to probe the quality of essential drugs and ensure drug safety.
Official figures show that China's National Center for Adverse Drug Reaction Monitoring received 692,904 reports of adverse reactions in 2010, up 8.4% compared with those in 2009.
Among the total, 109,991 cases involved new or severe adverse reactions, a year-on-year increase of 16.2%, Xinhua reported.