CVS Pharmacy announced Sept. 28 it would be suspending the sales of all Zantac-brand and CVS Health-brand ranitidine products until further notice, pending the results of an FDA investigation.
The FDA first issued a warning about ranitidine—a histamine-2 blocker that can be prescribed or sold over-the-counter to relieve heartburn and acid reflux—Sept. 13 after it identified low levels of N-nitrosodimethylamine (NDMA) in certain lots of the drugs. The presence of NDMA, a probable human carcinogen, in active pharmaceutical ingredients has forced several CV drug recalls in the past year.
The FDA hasn’t announced any recalls of ranitidine and doesn’t recommend heart patients stop taking the medication, and that’s something CVS emphasized in its own statement. The pharmacy said its move was a precautionary measure to keep patients safe while the FDA evaluates whether low levels of NDMA in ranitidine are a threat.
“This action is being taken out of an abundance of caution due to a recent product alert from the U.S. FDA that ranitidine products may contain a low level of NDMA, which is a probable human carcinogen,” the company’s statement read. “The levels that FDA is finding in ranitidine from preliminary tests barely exceed amounts found in common foods.”
According to CVS, people who have purchased Zantac or CVS-brand ranitidine can return those products to the store for a refund. In the meantime, patients can speak with CVS pharmacists about histamine-2 blocker alternatives that the store will continue to sell, including Pepcid, Tagamet, famotidine and cimetidine.