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On September 13, 2019, the US FDA announced that preliminary tests found low levels of N-nitrosodimethylamine (NDMA) in ranitidine, a heartburn medication. Novartis (through its generic division, Sandoz) and Apotex announced that they were recalling all of their generic ranitidine products sold in the US. GSK has also recalled its ranitidine medication sold in global markets including in India.
Ranitidine is an H2 (or histamine-2) blocker and is commonly used to relieve and prevent heartburn or to treat and prevent more serious ulcers in the stomach and intestines.
Health Canada, a federal department within the Canadian government, has asked all companies to stop distributing ranitidine drugs there, indicating that “current evidence suggests that NDMA may be present in ranitidine, regardless of the manufacturer.
France has taken the step of recalling all ranitidine products.
The Drug Controller General of India (DCGI) has asked all Drug controllers of states and UTs to communicate to the manufacturers of ranitidine active pharmaceutical ingredient (API) and formulations under their jurisdiction “to verify their products and take appropriate measures to ensure patient safety”.
One must look for alternative treatment options, including other drug classes like omeprazole, a proton pump inhibitor (PPI).
NDMA is an environmental contaminant that is found in water and foods, including dairy products, vegetables, and grilled meats. Its classification as a probable carcinogen is based on studies in animals; studies in humans are very limited.
NDMA in ranitidine products does not pose any immediate health risks. Although classified as a probable carcinogen, NDMA may cause cancer after exposure to high doses over a long period of time. NDMA is one of the same impurities that was found in angiotensin receptor blockers (ARBs) last year, which led to their recall from the market.
Has the time come to ask all pharmaceutical companies that their API salts do not have NDMA or any other impurity?
Dr KK Aggarwal
Padma Shri Awardee
President Confederation of Medical Associations in Asia and Oceania (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA