CVS Pharmacy has suspended sales of all ranitidine heartburn-combating products, including the brand-name version Zantac, “until further notice,” the chain said Saturday.
“This action is being taken out of an abundance of caution due to a recent Product Alert from the U.S. Food and Drug Administration (FDA) that ranitidine products may contain a low level of nitrosodimethylamine (NDMA), which is a probable human carcinogen,” the drug chain said in a statement.
CVS joins Walgreens, Walmart and Rite Aid in suspending the sales, according to BBC News.
On Sept. 19, Sandoz, owned by Swiss pharmaceutical giant Novartis, implemented a “precautionary distribution stop” of generic drugs containing ranitidine, an acid-blocking antacid and antihistamine, halting shipments but not stopping the sale of drugs already stocked, and not recalling the medicines.
Canada banned the sale of the drugs altogether, as did France, BBC News reported. Both the FDA and its counterpart the European Medicines Agency (EMA) are studying the issue.
In addition, Sandoz told BBC News it was recalling “several batches" of drugs containing ranitidine in Australia, Austria, Belgium, Canada, Croatia, the Czech Republic, Denmark, Finland, Germany, Hungary, Macedonia, Portugal, Slovakia, Slovenia, Sweden, Switzerland and the U.S.
At first only the generic versions of the drug were affected. Now Zantac, the brand-name product containing ranitidine, is also off the shelf.
This move, too, is purely precautionary, CVS and others said, given that the U.S. Food and Drug Administration (FDA) had detected only a minute amount of the impurity and was still investigating. The issue has been detected at higher levels in several blood pressure medications, which have been recalled. But the levels in the ranitidine are much lower.
“The FDA is continuing to evaluate whether low levels of NDMA in ranitidine pose a risk to patients,” CVS said. “The levels that FDA is finding in ranitidine from preliminary tests barely exceed amounts found in common foods.”
While Zantac and generic brand products containing ranitidine were not being recalled, and the FDA was not suggesting that patients stop taking them, CVS said customers could return the products for a refund if they so chose.
Other heartburn medications, such as Pepcid, Tagamet and the generic versions of those drugs, contain different active ingredients that do not have the impurity.
The FDA did issue a voluntary recall of the ranitidine-containing products on Thursday.
Apotex Corp., which manufactures the generic drug, voluntarily recalled the medicines “on a precautionary basis,” according to a statement from the FDA.
This did not apply to all generic versions of the drug, the FDA emphasized.
“Not all ranitidine medicines marketed in the U.S. are being recalled,” the FDA said.
While the agency did not recommend that people cease taking all over-the-counter ranitidine-containing medicines, it did say that “consumers taking OTC ranitidine could consider using other OTC products approved for their condition.”