Sale of Ranitidine Continues Despite U.S. FDA Warning

Following a U.S. Food and Drug Administration (FDA) warning about the presence of low levels of carcinogens in commonly used anti-acidity drug ranitidine, the Maharashtra Directorate of Health Services (DHS) has issued a circular to stop its use in government hospitals. However, the sale of ranitidine continues in chemist shops across the State.

On September 13, the U.S. FDA issued an alert for patients and healthcare professionals stating that ranitidine medicines, including some products commonly known by the brand name Zantac, 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. The FDA is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients and it will post that information when it is available.

Maharashtra FDA Assistant Commissioner (Drugs) D.R. Gahane said there was no intimation from the Drug Controller General of India to stop the sale of ranitidine-based drugs. “The Schedule H drug is available as oral tablets and injections under multiple brand names, the most popular being Rantac and Zinetac. We have collected samples of multiple brands and sent them for tests,” said Mr. Gahane.

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. While the U.S. FDA has not suggested stopping the use of ranitidine, it issued an alert so that patients and doctors can make an informed choice and opt for other molecules that have similar use as ranitidine, if needed.

According to Hakim Kapasi, president of the North West Chemists Association in Mumbai, GlaxoSmithKline Pharmaceuticals Ltd. has voluntarily recalled stocks but the sale of other ranitidine-based drugs is on. “Without any instruction from the FDA, chemists will continue to sell,” said Mr. Kapasi. – The Hindu

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