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Rantidine impurity scare: Many doctors say they still have faith in the age-old drug

In September this year, the US FDA had announced that preliminary tests found low levels of N-nitrosodimethylamine (NDMA) in ranitidine and nizatidine.

December 30, 2019 / 08:23 PM IST
Representative image

Representative image


The news of Ranitidine containing a probable cancer causing impurity at low levels has rattled patients who have been consuming it over the years.

"I have been receiving inquiries from worried patients on Ranitidine use after the spate of media reports," said Dr Rajiv Karnik, Interventional Cardiologist, Fortis Hospital, Mulund, Mumbai.

Karnik said he prescribes ranitidine to counter acid formation in patients as a side-effect of other medicines that are given for different heart conditions.

Karnik further added that Ranitidine (or H2 blocker) is considered to be more effective at bedtime at controlling acid breakthrough, with much less side-effect profile than Proton Pump Inhibitors (PPIs).

Pediatricians too said that they rely on Ranitidine as safe medication to use for neonates, infants and children.

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Avinash Rao, a senior pediatrician, told Moneycontrol that Ranitidine is not just affordable and safe, but it also comes in liquid form, more convenient formulation for children.

Karnik, Rao and several other doctors have been using ranitidine for years, and said the controversy generated around Ranitidine is putting the entire class of H2 blockers under the scanner.

Cancer impurities

In September this year, the USFDA announced that preliminary tests found low levels of N-nitrosodimethylamine (NDMA) in ranitidine and nizatidine.

The USFDA action was result of a Connecticut-based online pharmacy Valisure, which claimed it had detected extremely high levels of NDMA in multiple ranitidine products under in routine testing using gas chromatography-mass spectrometry (GC-MS).

USFDA developed a simulated gastric fluid (SGF) model used the Liquid Chromatography-mass spectrometry testing method to estimate the biological significance of in vitro findings.

The SGF and simulated intestinal fluid (SIF) models are intended to detect the formation of NDMA in systems that approximate the stomach and intestinal fluids, respectively. The results of these tests showed no additional NDMA generated in the stomach.

To be sure USFDA has determined that the levels of NDMA in ranitidine and nizatidine are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.

US FDA set the acceptable daily intake limit for NDMA at 0.096 micrograms or 0.32 ppm for ranitidine. The agency asked

Manufacturers are required to comply with the DCGI’s directives about

H2 blockers like ranitidine are cheap, safe and effective, there should

Ranitidine was commercially introduced in 1981, and has stood up to the expectations of medical fraternity for being safe and effective.

Ranitidine (also known by its brand name, Zantac, which is sold by the drug company GSK) is available both over the counter (OTC) and by prescription. It belongs to the class of drugs known as H2 (or histamine-2) blockers. OTC ranitidine is commonly used to relieve and prevent heartburn.

Prescription strengths are also used to treat and prevent more serious ulcers in the stomach and intestines. Multiple companies sell generic versions of both the OTC and prescription products.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Dec 30, 2019 08:15 pm

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