MUMBAI, OCTOBER 19: It is causing serious heartburn but even Cisapride, the antidote for this very condition, cannot neutralise the rising bile being shed over the efforts to push the drug by the Mumbai chapter of the Indian Medical Association (IMA). Raising serious ethical concerns, the IMA is pulling out the stops to thwart the effrots of the Union Health Ministry to ban Cisapride in India in the wake of its side-effects and even possible lethal consequences in the United States (US).
Issuing its own certificate of safety, the IMA claims that this over-the-counter formulation that has been in circulation in India since the last five to seven years is excellent in the treatment of heartburn, constipation and other gastronomic problems, never mind that the authorities in the United Kingdom (UK) and Germany are also considering yanking it off the shelves in their own countries. It says the only side-effects observed here are abdominal pain and diarrhoea and that physicians have had no complaints.
Dr Shobana Bhatia, a gastroenterologist who attended a seminar on the topic on Saturday, says Cisapride is used to treat multiple conditions. She says alternative drugs are in fact known for their side-effects on the Central Nervous System and they cannot be used continuously.
Making a case for the controversial drug, Dr Hozie Kapadia, senior IMA member, feels it should not be banned on the basis of the US findings. So what if the Union Health Ministry is in the process of sifting through data from both India and abroad on the subject. However, he admits that the IMA has not conducted a single study to support its safety but adds that the association plans to do so soon.
But there are others who feel that a decision should be left to the relevant authorities and not even an all-India medical body. He says that there were several recorded mortalities in patients who used Cisapride in the US and that the same could take place even in India. Though such mortalities were initially believed to have taken place in patients with cardiac conditions and aged between 65 and 90, they appear to be linked to deaths in younger patients as well, he says.
In the light of these revelations, certain IMA officials admit that Cisapride should be contraindicated for persons with cardiac arrythmia and it should not be used as a combination with the macrolide and azole groups of drugs.
Dr Sucharita Naniwadekar, consultant gastroenteroligist, says she has heard about the mortalities abroad and immediately stopped prescribing the formulation for her patients since last week. Even though she has observed side-effects such as mild diarrohea only, she says that for the present, the drug should be prescribed with caution, and simultaneously a clinical trials should be conducted to clear the haze of controversy.