As FDA Continues Zantac Tests, Agency Releases Lists of Safe Alternatives

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While the U.S. Food and Drug Administration (FDA) continues to test ranitidine-based products for potential contamination of the known carcinogen N-nitrosodimethylamine (NDMA), the regulatory agency released a list of alternative products that have been found free of the contaminant.

In its announcement on Thursday, the FDA said its preliminary tests of alternative antacid treatments such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) currently show no NDMA at this time based on testing.

The testing was conducted after the carcinogen was found in Sanofi’s Zantac, which prompted the company to issue a voluntary recall of its product from pharmacies in the U.S. and Canada Multiple pharmacy retailers, including CVS, Walgreens and Rite Aid have already removed ranitidine from their shelves until FDA reviews are complete.

On Thursday, the regulatory agency announced it was issuing an additional testing method to the manufacturers of ranitidine to test for NDMA. In addition to Sanofi, Dr. Reddy’s Laboratories also issued a voluntary recall of its prescription and over-the-counter (OTC) ranitidine tablets and capsules. GlaxoSmithKline and Novartis have also recalled or stopped production of their ranitidine tablets, Reuters reported.

As Reuters noted in its report, the question of whether or not Zantac had been contaminated with the carcinogen was raised by an online pharmacy, Valisure. In September, the FDA issued a report that showed some ranitidine medicines, including the brand-name drug Zantac, contain low levels of the nitrosamine impurity. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. In large amounted NDMA can cause health problems, but the FDA said the levels it initially found in ranitidine were low, however, those levels have been considered unacceptable for the product, which at one time was the best-selling medication in the world.

Ranitidine is an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach. It is sold over-the-counter, with one of the most popular versions being Zantac. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease, the FDA noted in its announcement.

Jeremy Kahn, a spokesman for the FDA, told Reuters that the agency is conducting the tests in order to “understand what happens to NDMA levels in the body, after ranitidine has been exposed to acid in the stomach.”

David Light, the chief executive officer of Valisure said the FDA testing of ranitidine products is important because his company’s data suggests the NDMA levels that can be formed in the body “are many magnitudes of order higher than what’s been talked about in the contamination,” Reuters said.

“This is one of the main red flags we’ve raised the whole time -- not just contamination but the fact that this is happening in the human body,” Light said, according to Reuters.

In addition to NDMA contamination of ranitidine products, the FDA has also had to raise red flags over some blood pressure medications that have been found to have NDMA. Teva Pharmaceuticals has had to recall lots of bulk Losartan Potassium due to the detection of N-Nitroso-N-methyl-4-aminobutyric acid discovered in the manufacturing process. That was the second recall for Israel-based Teva. November 2018, the company issued a voluntary recall for combination forms of its blood pressure drug Amlodipine due to cancer-causing impurities. In March, the FDA raised concerns about losartan potassium tablets sold by India-based Hetero Labs Ltd. and distributed by Camber Pharmaceuticals. Also last fall, the FDA issued a voluntary recall for lots of Irbesartan tablets developed by N.Y.-based ScieGen Pharmaceuticals due to the presence of the carcinogen.

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