A group of doctors from prominent government hospitals in the city came forward on Thursday to clear “misconceptions” about Ranitidine, an active pharmaceutical ingredient (API) used in drugs to treat gastric acidity.
Following a U.S. Food and Drug Administration (FDA) warning about the presence of low levels of carcinogens in Ranitidine, there are a lot of misconceptions about its use, said the doctors from Sri Jayadeva Institute of Cardiovascular Sciences, Kidwai Memorial Institute of Oncology, Indira Gandhi Institute of Oncology, and Bhagwan Mahaveer Jain Hospital.
On September 13, the U.S. FDA issued an alert for patients and healthcare professionals stating that Ranitidine medicines contain low levels of a nitrosamine impurity called N-nitrosodimethylamine (NDMA). “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests,” it said.
Ranitidine is an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach. It is also prescribed for ulcers of stomach and intestines, gastroesophageal reflux disease etc.
Claiming that Ranitidine has not been banned, T.R. Raghu, Professor of Cardiology at Jayadeva Institute, said none of the key pharmaceutical regulators such as the US FDA, the Drug Controller General of India (DCGI) /CDSCO have asked for a ban. “The recall by a few manufacturers in India was purely voluntary. The US FDA tested numerous Ranitidine products and found levels of NDMA similar to levels one would be exposed to if they ate common foods like grilled or smoked meats,” he said.
Purushottam Chavan, Assistant Professor, Head and Neck Onco-Surgeon at Kidwai Memorial Institute of Oncology said: “US FDA has clearly stated that a person taking a drug that has NDMA below the acceptable limit every day for 70 years is not at an increased risk of cancer. Also, Ranitidine is usually prescribed for short duration.”
Karnataka State Drugs Controller B.T. Khanapure also said that the drug has not been banned. “There is no intimation from the Drug Controller General of India to stop the sale of Ranitidine-based drugs. We have also not got any complaints about any adverse effects of the drugs so far,” he told The Hindu.
Meanwhile, the presence of a representative from one of the companies manufacturing a Ranitidine-based drug at the media interaction created doubts if the doctors were being “influenced” by the pharma company. However, Dr. Raghu denied there was any commercial interest. “This is one of the cheapest drugs and we have been using it for last 40 years in government hospitals,” he added.-The Hindu