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Retailers halt sale of Zantac, ranitidine OTC medicines

Some heartburn relief products may contain possible carcinogen, FDA warns

In response to a Food and Drug Administration alert, Hy-Vee, Raley's and Walmart announced they've suspended the sale of all over-the-counter Zantac and private-label ranitidine products, a heartburn relief medication.

Hy-Vee and Raley's said they've pulled all OTC Zantac and TopCare ranitidine products “out of an abundance of caution” after the FDA issued a warning last month that ranitidine medicines may contain the impurity nitrosodimethylamine (NDMA), a probable human carcinogen. Walmart said it's withdrawing all OTC ranitidine products in stores — including Sam's Club — and online under the Zantac, Equate and Member’s Mark brands.

The retailers said customers who purchased these medicines may return them for a refund. Raley's said members of its Something Extra loyalty program who bought the products within the last three months were notified of this issue via phone and email.

Part of the H2 (histamine-2) blocker drug class, ranitidine reduces production of stomach acid. Hy-Vee said its stores and pharmacies will continue to sell other over-the-counter H2 blockers, including the Pepcid and Tagamet brands and their respective generic equivalents, famotidine and cimetidine.

In a Sept. 13 statement, the FDA’s Center for Drug Evaluation and Research said some ranitidine medicines, including some Zantac products, contain low levels of NDMA, an environmental contaminant found in water and foods, including meat, dairy products and vegetables. The agency said it has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines (angiotensin II receptor blockers, or ARBs) since last year, and the NDMA levels found in ranitidine in early tests “barely exceed amounts you might expect to find in common foods.”

The nation's largest drugstore chains — CVS Pharmacy, Walgreens and Rite Aid — previously announced they were suspending sales of some ranitidine products pending the FDA’s further investigation. Drug maker Apotex has recalled 75-mg and 150-mg generic and OTC ranitidine products sold at Rite Aid, Walgreens and Walmart, while Sandoz has issued a recall for certain lots of 150-mg and 300-mg generic ranitidine products.

OTC ranitidine is indicated to prevent and alleviate heartburn associated with acid ingestion and sour stomach, while prescription ranitidine is indicated for multiple conditions, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease (GERD).

"The FDA is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients," according to Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. The FDA said consumers may want to consider other medications that treat their condition. "The agency is working with international regulators and industry partners to determine the source of this impurity in ranitidine," Woodcock added. "The agency is examining levels of NDMA in ranitidine and evaluating any possible risk to patients. The FDA will take appropriate measures based on the results of the ongoing investigation."

*Editor's Note: Article updated with new information on suspension of ranitidine product sales.

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