Ranitidine with components causing cancer
NEW DELHI: The Indian drug regulator has ordered an investigation into the popular antacid drug commonly known as ranitidine. The reason is for the possible presence of an impurity that can cause cancer after recent reports and a decision by Dr Reddy, the largest drug specialist, has picked up the product of the shelves.
The Central Drug Control Organization, which regulates the quality, safety and efficacy of medicines in India, has referred the matter to a committee of experts for a detailed examination. The panel will examine several ranitidine brands sold in the country.
Although most international regulators, including USFDA and EMA, did not ban the drug, regulators advised the public to be cautious and consult their doctors. Some regulators, including Health Canada and Health Sciences Authority (HSA) of Singapore, started the recall as a precautionary measure.
In addition to heartburn, ranitidine is also used in the treatment of intestinal ulcers, gastroesophageal reflux disease (GERD), esophagitis, Zollinger-Ellison syndrome and other diseases. While the drug is a “prescription” product in India, it is often sold without a prescription without consulting a doctor.
The Indian regulator wrote to drug controllers and producers asking them to verify their products and take appropriate measures to ensure patient safety, a senior official told WOMS. The measure was triggered by safety warnings from several international regulators, including the U.S. Food and Drug Administration. UU. (USFDA), considered the most stringent drug regulatory authority worldwide, asking physicians and patients to be cautious and report side effects or adverse effects related to medications.
The world’s leading regulators, including the USFDA and the European Medicines Agency, are investigating the presence of a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels in some ranitidine-based medications, including some brands commonly known as Zantac.