Satisfied with the answer of nimesulide-induced hepatic failure (originally see below) Ireland food and drug administration in May 15, 2007 announced the suspension of nimesulide (nimesulide) oral preparations sold on the market, involving nimesulide preparation including 3 brand of 100 mg tablets and granules.
Nimesulide is a non-steroidal anti-inflammatory drug, selective inhibition of cyclooxygenase, have significant anti-inflammatory, analgesic and antipyretic effects, mainly for the treatment of arthritis, acute inflammation, pain, primary dysmenorrhea, and fever. Thanks to its unique pharmacological mechanisms, the drug has been recognized as a clinical onset fast, good, high security, has good prospects for development of non-steroidal anti-inflammatory drugs.
Nimesulide adverse reactions mainly gastrointestinal reaction, but relatively rare, and symptoms of mild, transient, rarely need to interrupt treatment. However in recent years, the number of severe liver toxicity has been reported.
Spain people with drug safety Committee review is of the view that the use of the drug than other non-steroidal anti-inflammatory drugs increase risk of liver damage. The Committee noted that the cause of such damage occurring is the mechanism seems to be due to the specificity of the Constitution, and has nothing to do with their medication dose, so it is difficult to predict; but there is evidence that nimesulide to cause gastrointestinal bleeding and perforation occurred rate than other non-steroidal anti-inflammatory drugs. Finland, Spain and Turkey after sale of nimesulide.
Ireland require manufacturers to take the post-marketing safety study shows that made its collection of 1 212 patients datasheet Minnie nimesulide diclofenac and ibuprofen security without obvious differences. However, Ireland food and Drug Administration recently received from Saint Vincent College National liver transplant institutions as of six case reports of patients who have used nimesulide treatment and liver failure to accept the transfer.
Since 1995 nimesulide listing in Ireland, a total of 53 cases of adverse reactions received, the 9 cases of liver failure, of which three resulted in death. Ireland food and Drug Administration has recently informed the European States related departments starting with nimesulide-preparation of the review report, the workers and to remind patients to immediately stop using the drug. Nimesulide was originally developed by Switzerland Helsinn, 1985 by Roche company in Italy for the first time listing in 50 countries.
China has the capsules, granules, tablets and cefpodoxime, sustained-release capsule and other dosage form listing, which caused the death of liver failure. Patients in the use of nimesulide process if hepatic dysfunction symptoms appear, such as general discomfort, nausea, abdominal pain, jaundice, or should the doctor consultation in a timely manner. (Fourth military medical University Tang hospital infection disease diagnosis and treatment centre, Xi’an 710038) summary of a man suffering from such rheumatic diseases of the 8-year-old man taking nimesulide 50 mg per time, 2 times/day. 77 days after treatment, patients appear weak, sick and jaundice.
Admission after day 2 of coma, accepted appears on disease treatment, plasmapheresis and continuous Veno-venous Hemofiltration for hemodialysis. Children die of liver failure. Discussion: a non-steroidal anti-inflammatory drug (NSAID) clinical application of a very wide range, but whose liver damage is often overlooked. The majority of NSAID-induced hepatic damage to specific physical reaction, characterized by low incidence, has nothing to do with the dose, the incubation period is longer, it happens often unpredictable. One of nimesulide for Cox-2 (COX-2) selective inhibitors, compared with COX-1 inhibitor, strong anti-inflammatory and antipyretic effect, and gastrointestinal side effects, since 1985 has been listed in 50 countries, but then have three European countries due to liver damage reactions and its withdrawal from the market.
Nimesulide to serious liver injury 0.1/10 million, to date, more than 30 cases worldwide of nimesulide cause serious liver damage report, of which there are more children in India: a case report of countries not yet see nimesulide-induced acute fulminant hepatitis. This 9-year-old children, both to take “aspirin” control of rheumatic diseases, no abnormal liver function, no history of acute and chronic liver disease. 2 and a half months ago admitted drug nimesulide, take more than 2 months after the liver damage prodrome until 5 d jaundice before withdrawal. Children in the sharp deterioration in the condition 10d, jaundice, liver encephalopathy, acute liver failure performance and ultimately death.
Combined admission related checks excluded l. liver viruses and non-preferable vivus of viral hepatitis, Wilson disease, Reye’s syndrome, drug-induced hepatitis diagnosis was established. With this experience and foreign-related reports, tip we should be wary of nimesulide liver toxicity problems. Liver damage to existing patients and children should be used with caution in patients, clinical application period it should be noted that monitoring the changes in liver function.