The popular over-the-counter heartburn medication Zantac has been voluntarily recalled by its manufacturer, Sanofi, because of U.S. Food and Drug Administration warnings that it contains a potentially cancer-causing impurity.
Last month the FDA alerted the public to the existence of low levels of the carcinogen, N-nitrosodimethylamine, or NDMA, in heartburn drugs known as ranitidine medications (in a class of drugs called H2 blockers), including those under the Zantac brand.
The news caused Walmart, CVS Pharmacy and Walgreens to halt sales of ranitidine drugs, which are now being tested for their potential risks. (The presence of NDMA in certain forms of the high blood pressure medication valsartan is also under FDA scrutiny.)
The FDA has not demanded a recall of Zantac, used widely to treat heartburn and ulcers by lowering acid production in the stomach, and suggests that those who want to stop taking prescription Zantac should first discuss other options with their doctors.
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"Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods,” the agency said in its September alert.
Now Zantac's manufacturer is expanding their voluntary recalls. On Friday, Sanofi announced a recall of Zantac OTC in the U.S. and Canada. Teva Pharmaceutical and GlaxoSmithKline, among others, have also begun recalls for versions of the medicine.
CVS has said that customers who've purchased the products can return them for a refund and that “CVS Pharmacy will continue to sell other over-the-counter H2 blockers, including Pepcid, Tagamet and their respective generic equivalents, famotidine and cimetidine."