Millions of American heartburn sufferers were suddenly left in the lurch after the Food and Drug Administration (FDA) announced April 1 that it was pulling all prescription and over-the-counter medications containing the drug ranitidine, the active ingredient in the brand-name Zantac, due to the presence of a probable cancer-causing impurity known as NDMA. In light of the Zantac recall, many are left to wonder, are there any safe alternatives?
About 60 million Americans suffer from heartburn. Of them, about 15 million take a prescription version of Zantac, and untold millions of others take over-the-counter Zantac or generic ranitidine daily to manage the pain and discomfort of their acid reflux.
NDMA is a substance that is naturally occurring in the environment. People consume low levels of NDMA daily in food and water. Though NDMA is a probable human carcinogen—studies on laboratory animals have linked high levels of NDMA exposure to tumor growth—small amounts in the diet are not thought to put consumers at an increased risk for cancer.
The problem with Zantac and other ranitidine products, the FDA said in a news release, is that NDMA levels increase in Zantac even under normal storage conditions, especially at higher temperatures or during a longer shelf life. These conditions could raise levels of NDMA in Zantac and other ranitidine products above what the FDA considers acceptable daily intake levels.
Ranitidine is in a class of drugs called H2 (histamine-2) blockers. In January, another H2 blocker, Axid (nizatidine), was recalled after it was found to contain trace amounts of NDMA. Axid and Zantac were chemically similar. To date, the FDA hasn’t ordered the removal of Axid or other nizatidine products from the market.
The FDA is advising consumers to stop taking any over-the-count ranitidine tablets or liquid, and to dispose of them properly. People taking prescription ranitidine products should talk with their doctors about an alternative medication.
Some heartburn alternatives on the market that have been tested by the FDA and do not show higher than acceptable levels of NDMA include Pepcid (famotidine) and Tagamet (cimetidine), and medications from another class of drugs known as proton pump inhibitors, or PPIs, such as Nexium (esomeprazole), Prevacid) (lansoprazole) and Prilosec (omeprazole).
Dozens of consumers are holding Zantac manufacturer Sanofi and other makers of ranitidine accountable, and have filed lawsuits against Big Pharma for putting profits ahead of patients.