In the development process of Nimesulide, there have been some twists and turns. Through large-sample clinical research and scientific analysis, many questions have been clarified. The important events of Nimesulide will help you to understand the whole picture of Nimesulide products.
1. In the late 1960s, the American 3M Pharmaceuticals Company invented Nimesulide, a new chemical entity. The synthesis process was patented in the United States in 1974, with the patent number U.S.P. 3856859.
2. In 1980, the Swiss company Helsinn obtained the exclusive worldwide patent rights for Nimesulide.
3. In 1985, Nimesulide was first launched in Italy. It is currently used in more than 50 countries. Its market size exceeds US$1 billion.
4. In 2002, Finland suspended the use of nimesulide because it was suspected that serious liver toxicity events may be related to the use of nimesulide. Spain and Türkiye have also decided to suspend use. The safety of nimesulide has received attention from the media and the pharmaceutical industry.
5. Large sample re-evaluation data confirms that Nimesulide has good benefit/risk characteristics and is a safe and effective drug.
⑴ At the India-UK "Hot Topics in Pediatrics" seminar on February 1-2, 2003, Professor H.P.S. Sachdev chaired the research topic - "Safety of Oral Nimesulide in Children" Published at the conference, the study confirms the safety of short-term oral nimesulide (lt; 10) days in children compared with other antipyretic analgesics, such as acetaminophen, ketoprofen, naproxen, There were no significant differences between fenamic acid, aspirin, or placebo. Gastrointestinal adverse effects were comparable to acetaminophen or placebo and superior to other control drugs. The research results were generally recognized by experts attending the meeting.
⑵ In 2003, the British Medical Journal published a re-evaluation report by Traversa et al. of the Epidemiological Research Department of the Italian National Institute of Health. The author used a retrospective cohort study and a nested case-control study to conduct an analysis of the Umbria region of Italy in 1997. The safety of 400,000 patients (2 million prescriptions) who used NSAIDs from January to December 31, 2001 was re-evaluated. The data confirmed that: Nimesulide is safe to use, and hepatotoxicity and other Nonsteroidal drugs are similar.
6. In 2003, the European Medicines Evaluation Agency (EMEA) affirmed that nimesulide has good benefit/loss properties and is a safe and effective drug for treating a wide range of inflammation and pain.
7. After Spain and Finland stopped selling Nimesulide in 2002, the Committee for Medicinal Products for Human Use of the European Medicines Agency made a positive evaluation of Nimesulide, and Spain and Finland resumed Nimesulide in 2004. Profitable sales.
8. In 2003, the Committee for Protection of Child Consumers of the Indian Academy of Pediatricians issued a unanimous statement on the safety of nimesulide in children: the safety of short-term oral nimesulide (lt; 10 days) in children The safety profile is not significantly different from other antipyretics and analgesics or placebo; gastrointestinal adverse effects are better than other control drugs, such as ketoprofen, naproxen, mefenamic acid or aspirin, but are different from acetaminophen or aspirin. Placebo equivalent.
9. In April 2004, the European Union officially adopted the practical and scientific evaluation of Nimesulide by the European Medicines Evaluation Agency (EMEA), once again affirming that Nimesulide has good efficacy in treating a wide range of inflammation and pain. The benefit/loss properties make it a safe and effective drug.
10. On March 10, 2004, the Delhi High Court in India reviewed the safety of Nimesulide and agreed with the findings of the Drugs Technical Advisory Board (DTAB): In fact, Nimesulide is very useful and medically It is well accepted by the community; the overall data do not support that it should be banned; there is no reason to ban nimesulide in pediatrics; the drug should be allowed for use in adults and children. The Indian Academy of Pediatrics also endorsed the continued use of nimesulide in pediatrics.
11. On October 5, 2005, Helsinn held a celebration event in Rome, Italy to celebrate the 20th anniversary of the launch of Nimesulide. The product sales have reached 13.5 billion boxes (equivalent to 530 million boxes, approximately 450 million patients) receiving treatment with this product), it ranks among the top 5 anti-inflammatory drugs in the world. Mr. George Moore, the inventor of Nimesulide molecule, was also invited to participate.
12. On May 15, 2007, Ireland stopped selling Nimesulide due to reports of 6 cases of liver injury, and requested the European Medicines Agency's Committee for Medicinal Products for Human Use to review the efficacy/risk relationship of Nimesulide.
13. The evaluation of the Committee for Medicinal Products for Human Use of the European Medicines Agency on September 21, 2007 affirmed the efficacy of nimesulide and limited its course of treatment to no more than 15 days, and did not require other European countries to suspend its use. Nimesulide for sale.
14. The State Food and Drug Administration (SFDA) attaches great importance to the safety of Nimesulide. SFDA attaches great importance to the monitoring of adverse reactions of domestically marketed drugs, pays close attention to the safety re-evaluation of similar drugs abroad, and constantly modifies the instructions for marketed drugs to determine the safety of Nimesulide.
SFDA also pays close attention to, especially the safety of children. SFDA carefully listened to the evaluation of the efficacy and safety of this product by pediatric medical experts, and had an in-depth and detailed understanding of the adverse reaction information of this product. After strict review and scientific evaluation, it is believed that Nimesulide can treat respiratory infections, ear, nose and throat caused by colds and other causes in children. Or fever caused by digestive system infection has good efficacy and safety. On June 11, 2008, an order was issued to modify the instructions for the oral preparation of Nimesulide, stipulating that Nimesulide's children's medication should only be used for children over 1 year old. The dosage The dosage is 5mg/kg/day, taken in 2 to 3 times, the maximum dose does not exceed 100mg, 2 times a day. Used to reduce fever, the course of treatment should not exceed 3 days. For rheumatism, the course of treatment should be as directed by your doctor.
15. On April 10, 2010, the Hainan Provincial Adverse Drug Reaction Monitoring Center issued an approval document for the domestic enterprise’s application to the regulatory authorities for another inquiry on the safety of the drug. In this approval document, the following is written about "Nimesulide": "After searching the "Adverse Drug Reaction Information Bulletin" issued by the National Center for Adverse Drug Reaction Monitoring (November 2001 to March 2010), there is no Information notification on adverse reactions related to three types of drugs: Nimesulide, Acetaminophen, and Ibuprofen."