CVS Stops Selling Zantac Products

By George Stahl and Thomas M. Burton

CVS Health Corp. has stopped selling Zantac products at its drugstores, citing a recent alert by the U.S. Food and Drug Administration that the popular heartburn drug could contain low levels of a probable human carcinogen.

CVS said Saturday that it is taking the action "out of an abundance of caution." There is no recall of the product, but customers who purchased these products at CVS can return them for a refund.

Zantac is sold by Sanofi and generically under the name ranitidine. A Sanofi spokesman said Sunday that the company is working closely with the FDA and conducting its own investigations. The company has no plans to stop distributing or manufacturing Zantac or other ranitidine products, he said.

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.

The agency has said it is evaluating whether low amounts of the chemical pose a risk to patients, and that it would make that assessment available publicly as soon as possible. The FDA isn't recommending individuals stop taking ranitidine medicines at this time.

Last week, the FDA announced a voluntary recall of over-the-counter ranitidine tablets, labeled by Walgreens, Walmart and Rite-Aid. Novartis AG's Sandoz generic-drugs business also voluntarily recalled its ranitidine products. Sandoz said it hasn't received any reports of adverse events related to use of the product.

Ranitidine, originally thought of as an ulcer drug, is approved for treatment and prevention of ulcers in the stomach and intestines as well as for heartburn. Sanofi has said that Zantac has been around for over a decade and meets all the specified safety requirements for use in the over-the-counter market.

Ranitidine is considered an H2 blocker, which reduces stomach acid by blocking acids that produce it. CVS said its pharmacy will continue to sell other over-the-counter H2 blockers, including Pepcid, Tagamet and its respective generic equivalents, famotidine and cimetidine.

Many generic drugs for high blood pressure have been found to be contaminated by low levels of NDMA and related carcinogenic chemicals. The FDA has grappled with NDMA for more than a year, principally in generic drugs. The agency has acknowledged that two million or more people world-wide had been exposed to the chemical in blood-pressure drugs. These included generic drugs like valsartan, irbesartan and losartan.

Write to George Stahl at george.stahl@wsj.com and Thomas M. Burton at tom.burton@wsj.com

(END) Dow Jones Newswires

September 29, 2019 17:25 ET (21:25 GMT)

Sanofi (EU:SAN)
Graphique Historique de l'Action
De Mar 2024 à Avr 2024