WASHINGTON, DC -- Zantac has been found to contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels, stated the U.S. Food and Drug Administration (FDA). NDMA is classified as a probable human carcinogen and could possibly cause cancer, they said.

NDMA is the same drug that was found in the Valsartan, a blood pressure medicine that initiated a widespread recall.

Ranitidine, an H2 blocker, is an over-the-counter and prescription drug which decreases the amount of acid created by the stomach, stated the FDA in a press release. Over-the-counter Ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach, the release said. Prescription Ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease. The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year, they said. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.

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At this time, the FDA is not calling for people to stop taking ranitidine. However, the FDA stated that people "could consider" taking other over-the-counter medicines approved for their contition. The FDA also stated that patients taking prescriptions of the drug who wish to discontinue use, should talk to their doctor about other treatment opitons.


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