New Delhi, Feb. 2 (PTI): The Centre has asked the Indian Academy of Paediatrics to study the safety of drug nimesulide and recommend if it should be banned for children.
No serious concern on the use of the common pain-and-fever drug has been raised so far during a review, in which the opinions of some top paediatricians were also sought, health ministry sources said.
“Still, we would like to have a wider discussion on the matter,” the sources said. The academy’s study would help reach a final decision.
“We have been requested by the drug controller of India to come out with an opinion. The report would be submitted within three months,” Dr Nitin K. Shah, secretary-general of the academy, said.
“The study would be carried out by the IAP’s committee on protection of child consumers,” he said. All available national and international data and studies will be analysed before the academy reaches an opinion, Shah said.
The academy has around 15,000 paediatrics as members, several of whom are working in medical colleges. All of them would be asked to describe their experiences with nimesulide. An opinion would be reached in the process. The academy would then recommend if the drug should be banned or not. If the drug is to be banned, the academy would prescribe the conditions when it should be used for children, the dosage and frequency, Shah said.
The drug needs a review, said Dr Y.K. Amdekar, honorary professor (Retd) of paediatrics, Grant Medical College, who is one of the experts whose opinion the drug controller had sought. “Side-effects need to be discussed. But every drug has side-effects,” he said. “The question is whether it is the drug that is responsible for them or the patients (alcoholics or diabetics are likely to suffer more side-effects) or the doctors.”
According to Amdekar, an opinion should be reached only after the collection of wide data and a thorough analysis.
There is a need to inform people that pain and fever are the body’s protective mechanisms; fever usually does not kill, he said. “We should know when to treat and when not. Besides, it is not necessary that a drug will bring down the fever.”
Only paracetamol, a drug for fever, is considered safe enough, he said, and the drug controller had allowed its sale over the counter.
The side-effects are often determined by the frequency of dose, Amdekar said. For paracetamol, the gap between two doses is four hours; six hours for brufen, and 8 to 12 hours for nimesulide.
According to Amdekar, nimesulide is not used in many European countries and the US, thus triggering doubts about its use. It is a comparatively new drug without much recorded evidence on its use.