Nimesulide – Pain Killer or Pain Maker

Nimesulide is back in limelight. Thanks to the survey conducted by Indian Medical Association (IMA) which assured the country that this drug is safe for human body despite the fact that it is banned in some European countries like Finland, Spain, Portugal and not licenced in USA, Britain and Australia. Fingures are putting up in the mode of survey also. Some 50 doctors were participated and they submitted their data on the use of drug on half a million  patients.

Nimesulide is an NSAID (Non-Steroid Anti-Inflammatory Drugs ) which is used in pain and fever management treatment. It is also frequently used in combination with yet another analgesic Paracetamol. In the last few years, nimesulide-based analgesics have overtaken the paracetamol-based analgesics  

Nimesulide is usually given in doses of up to 200 mg twice daily by mouth or rectally for inflammatory conditions, fever, and pain. In India around 90 companies manufacture this drug out of which some 10 companies prepare Kids formulation. 

There are plenty of cases in which nimesulide is proved to be dangerous while there are some reports that its use is safe. Many references of  nimesulide treatment is mentioned in Toxicology Literature Online Databank (TOXLINE), a database of the National Library of Medicine's TOXNET system.

Nimesulide was considered effective in treatment for the short-term management of post-traumatic pain  in a study published in Drugs; VOL 46 ISS Suppl 1 1993, P183-186. Even in dental surgeries (Drugs; VOL 46 ISS Suppl 1 1993, P168-170), use of nimesulide proved more effective in the painful inflammatory symptoms and signs associated with the operation. These effects were accompanied by improved quality of sleep and recovery of swallowing function. According to one study which was published in Journal Drug Invest.; VOL 10 ISS Sep 1995, P139-146. nimesulide was associated with a statistically significant improvement in the pain intensity in osteoarthritis and gives improvement in the number of night awakenings, pain on active and passive movement, and morning stiffness. In another study published in Drugs; VOL 46 ISS Suppl 1 1993, P180-81 it was observed that nimesulide was effective in the prevention of inflammatory complications after laser treatment of ocular diseases.  

While comparing nimesulide with paracetamol it was observed  (Drugs Exp. Clin. Res.; VOL 18 ISS 2 1992, P63-68), that nimesulide exhibited a more rapid tendency to temperature normalization than paracetamol. In paediatric cases one study published in Drugs; VOL 46 ISS Suppl 1 1993, P231-233 approves its effectiveness on children suffering with inflamation of the upper repiratory tract and fever. Another study of Drugs; VOL 46 ISS Suppl 1 1993 Page 204-207 shows that nimesulide was more effective than paracetamol in normalizing body temperature and in reducing the inflammatory indices.

This drug proves to be effective on aspirin-sensitive asthmatic patients and may provide a novel approach to the
 treatment of bronchial asthma as per report published in Drugs; VOL 46 ISS Suppl 1 1993, P115-120. 

On the flip side a study published in Drugs; VOL 46 ISS Suppl 1 1993, P277-280 put emphasis on adverse
 events of using nimesulide which were related to the digestive system, body as a whole, skin, and nervous system. 
The drug was particularly well tolerated by the liver, lungs, kidneys, and blood.

While a study published in Drugs; VOL 46 ISS Suppl 1 1993, P111-114 warns that nimesulide in chronic bronchitis
 deserves further investigation.

An article published in the October 1999 issue of  Israel Medical Association Journal (IMAJ) mentioned that 
nimesulide may cause liver damages. It may vary from abnormal lever enzyme levels to fetal hepatic failure. 

In numerous short term clinical trials NSAIDs have been found to be superior in easing the pain of osteoarthritis (OA), however the toxicity of NSAIDs remains of concern. Risk factors for gastro-intestinal (GI) complications with the use of NSAIDs include age over 65 years, history of peptic ulcer disease/gastritis, smoking, constant use of glucocorticoids and consumption of alcohol. Not all NSAIDs are suitable for long term treatment. 

In a survey conducted by Dr. Reddy's Laboratories, a manufacturer of Nimesulide which was published in the medical journal Indian Pediatrics Vol 39, Year 2002, 6% of 4000 surveyed patients reported different adverse events out of which 129 patients reported gastrointestinal problems; 72 have skin and mucous membrane; 28 suffered from diarrhoea, nausea and black stools. Around 55 patients reported vomitting. 

Whether nimesulide is safe or not, one cannot conclude with a survey conducted by Indian Medical Association or any other group of doctors, it needs further investigations, trials and studies. Moreover the survey was conducted by IMA whose Secreatary General is Dr. Sanjiv Malik who is also the Chairman and chief editor of Medical publication house Mediworld Publications which publishes medical articles on different specialities and many of them are sponsored by drug manufacturing companies. A key question can be asked : Is this survey also sponsored by some Nimesulide manufacturing company?  Whatever be the result of this controversy, the real judge should be the scientists who can test the efficacy and contraindications of this drug and not some doctors or IMA or chairman of a publishing house.

 

 

r Pratiman Uniyal