Following a Food and Drug Administration warning last month that it had detected low levels of a cancer-causing chemical in samples of Zantac, pharmacy chains CVS, Rite Aid, and Walgreens immediately acted to pull the heartburn medicine from store shelves.
In a statement, a Walgreens spokesman said that the company has stopped selling the drug “while the FDA continues its review of the products.” A Rite Aid spokesman also said they were “in the process of removing Zantac and generic versions sold under the Rite Aid name from its shelves.”
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Both Walgreens and CVS announced the move although both said the drug (also known as ranitidine) had not been recalled. Still, customers who purchased the products can ask for a refund.
The FDA further announced that investigations to determine the source of the contamination are ongoing as well as assessments to patient risk. They did advise patients to consult with their doctors and that those who use the over-the-counter versions to use different medications in the meantime.
Sanofi produces the drug with the brand name Zantac although generic versions are widely available.
Sandoz, the generic drug division of Novartis, has also moved to freeze distributing a prescription form of ranitidine globally pending an investigation of the FDA’s findings. GlaxoSmithKline and Dr. Reddy’s Laboratories have also stopped shipping out generic versions of the drug.
However, all the drug companies have stopped short of issuing a recall of the drug in the US. Sanofi said in a statement that the amount of contaminant the FDA found in “preliminary tests barely exceed amounts found in common foods.”
The company added: “We are working closely with the F.D.A. and are conducting our own robust investigations to ensure we continue to meet the highest quality safety and quality standards.”
Apotex, which produces the store-branded versions of Zantac for Walmart, Walgreens, and Rite-Aid, also recalled its ranitidine products last week.
The European Medicines Agency is also now reviewing the drug while Canada has instituted a halt of all distribution of ranitidine.
The FDA warning which was issued on September 13 stated that low levels of a type of nitrosamine called nitrosodimethylamine, or NDMA, were discovered in ranitidine samples.
In lab animals, nitrosamines caused tumors to form in the liver and other organs and are thought to be carcinogenic in humans. The FDA stated that if the chemical reactions in manufacturing the drug are not carefully controlled, NDMA can form during the manufacturing process.
Ranitidine works as a histamine blocker to counteract the acid created in the stomach. Sometimes, the ranitidine is prescribed to prevent stomach and intestinal ulcers, as well as for treating gastroesophageal reflux disease.
CVS announced that other histamine blockers such as Pepcid, Tagamet, and generic equivalents cimetidine and famotidine will still be sold in their stores.
Replaced!