FDA Scanner on Heartburn Drug Ranitidine Raises Concerns in India; Regulators Asked to Take Measures

New Delhi: A study done by the US Food and Drugs Administration has revealed the presence of low levels of N-nitrosodimethylamine or NDMA in some Ranitidine medicines and this has led to concerns in India.

NDMA is a chemical found in both industrial and natural processes. It is classified as a probable carcinogen, a cancer-causing chemical. Ranitidine is an over-the-counter (OTC) and prescription drug. It is an H2 (histamine-2) blocker which decreases the amount of acid created by the stomach.

Over-the-counter Ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach. Prescription Ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease, says the FDA.

In the US, the popular brand name is Zantac. In India, the most common drugs are Zinetac and Rantac, manufactured by GSK and JB Chemicals, respectively.

Drugs Controller General of India Dr VG Somani has written to state and Union drug controllers to communicate to manufacturers of Ranitidine API and formulations to verify products and take appropriate measures to ensure patient safety and also inform the DCGI of the action initiated. News18 is in possession of this letter.

The FDA says it is not calling for individuals to stop taking Ranitidine at this time. However, there should be other treatment options available. The advice also is that there are multiple drugs in the market that are approved for similar use as Ranitidine. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products says the FDA.

While there has been neither a recall nor an advisory to doctors or patients in the country, outside India Novartis AG’s Sandoz has halted worldwide distribution of Zantac.