Commentary

'Abundance Of Caution' Over Small Amount Of Possible Carcinogen In Zantac

Major pharmacy chains have stopped selling Sanofi’s heartburn remedy Zantac and its generics because they possibly contain a small amount of a chemical -- nitrosodimethylamine (NDMA) -- that may cause cancer in large amounts. 

“Earlier this week, CVS, Rite Aid, and Walgreen’s suspended sales of Zantac (ranitidine) products. This follows  the announcement last month by Sandoz, the generics division of Novartis, that it was voluntarily recalling all lots of its 150 mg and 300 mg ranitidine hydrochloride capsules ‘because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA,’” Joshua Cohen writes  for Forbes.

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Since then, Apotex and GlaxoSmithKline have also pulled generic versions of Zantac sold at Walgreens, Walmart and Rite Aid.

CVS, the first chain to suspend sales of Zantac and its generics, says the move was taken out of “an abundance of caution.”

“Zantac brand products and CVS brand ranitidine products have not been recalled, and the FDA is not recommending that patients stop taking ranitidine at this time,” CVS points out in a statement. It says that customers who purchased the products at CVS can return them for a refund.

"The agency is still testing Zantac and its generic versions. A private lab that found the contaminant in ranitidine and alerted the FDA said the problem stems from the composition of the drug, not a manufacturing flaw,” Brett Molina writes for USA Today.

“The FDA said it’s not calling for users to stop taking ranitidine, and not all ranitidine medicines marketed in the USA face a recall,” Molina adds.

“The FDA has said the chemical, known as NDMA, could cause harm in large amounts; however, the levels it is finding in preliminary tests of Zantac ‘barely exceed amounts you might expect to find in common foods.’ The chemical is part of a class of compounds called nitrosamines that are found in water and in foods like meats, dairy products and vegetables,” George Stahl and Thomas M. Burton report  for the Wall Street Journal.

“Nitrosamines can cause tumors in the liver and other organs in lab animals, and they are believed to be carcinogenic in humans. NDMA can form during manufacturing if the chemical reactions used to make the drug are not carefully controlled, the FDA. has said,” Sandra E. Garcia writes  for The New York Times.

Ranitidine is a histamine blocker that works to lower the acid created in the stomach, according to the FDA. The medication is sometimes prescribed to prevent ulcers of the stomach and intestines as well as gastroesophageal reflux disease, the agency says,” Garcia continues.

“On its website, the FDA is now linking to a portal for consumers and health care experts to ‘report any adverse reactions’ to ranitidine, in hopes of gaining a clearer understanding of how the chemical is affecting those using it. But for now, the organization’s director of drug evaluation and research Janet Woodcock, M.D., does not seem overly concerned,” Abby Haglage writes  for Yahoo Lifestyle

“Patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health. Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods,” Woodcock writes, Haglage reports.

That doesn’t leave much more for Sanofi’s spokespeople to say except what they did: “We are working closely with the FDA and are conducting our own robust investigations to ensure we continue to meet the highest quality safety and quality standards,” Peter Sullivan reports  for The Hill.

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