CVS Pharmacy has decided to remove all Zantac-like heart burn medications from store shelves across the country, amid growing concerns that the drugs are exposing consumers to a probable carcinogen.
Over-the-counter and prescription versions of ranitidine (name brand Zantac) are used by millions of Americans to control heart burn symptoms and treat other disorders caused by the excess production of stomach acid.
Earlier this year, however, the online pharmacy Valisure informed the U.S. Food & Drug Administration (FDA) that it had detected N-nitrosodimethylamine, or NDMA, in every sample of Zantac and ranitidine it tested. According to the company, levels in some samples were far above the daily limits set by the agency. Valisure also suggested that the presence of NDMA was due to the instability of the ranitidine molecule, which degrades under the conditions created by digestion.
The U.S. Environmental Protection Agency has designated NDMA a probable human carcinogen. Animal studies suggest exposure increase the risk for cancer, especially liver, kidney, and gastrointestinal tumors.
According to a Zantac warning issued on September 13th, the FDA is investigating whether the “low levels” of NDMA detected in Zantac and ranitidine pose any health risk. The agency did not order a Zantac recall, but did urge consumers using over-the-counter products to consider switching to another antacid. Those taking prescription ranitidine should not stop without first speaking with their doctor, as doing so could cause their condition to worsen.
Since then, Canadian regulators have ordered drug makers to stop shipping Zantac and ranitidine in that country. Novartis recalled all ranitidine products marketed by its Sandoz, Inc. subsidiary after confirming the presence of NDMA at levels above the FDA limits. And last week, Apotex Inc. recalled all store-brand ranitidine manufactured for Walmart, Walgreens, and Rite-Aid.
On Saturday, CVS said it was removing all Zantac-like drugs from store shelves “out of an abundance of caution.” Customers who purchased the products can return them to CVS stores for a refund.
CVS will continue to sell other over-the-counter H2 Blockers, including Pepcid, Tagamet and its respective generic equivalents, famotidine and cimetidine.
This isn’t the first time NDMA has turned up in widely-used medications. Last year, compound was the first of three potentially cancer-causing nitrosamines detected in active pharmaceutical ingredients for generic valsartan, losartan, and irbesartan products, resulting in dozens of recalls around the world. The FDA eventually traced the contamination to ingredients supplied by manufactures in China and India.