Zantac Equivalent From Walmart, Walgreens May Have Carcinogens

ACROSS AMERICA — A popular heartburn medication may contain cancer-causing ingredients, according to the U.S. Food and Drug Administration.

The FDA is alerting health care professionals and patients that the over-the-counter drug ranitidine tablets (75 mg and 150 mg), labeled by Walgreens, Walmart and Rite-Aid are under a voluntary recall. Marketed as an equivalent version of the drug Zantac, these medicines may contain low levels of a nitrosamine impurity called N-nitrosodimethylamine. Consumers taking ranitidine, which is used to prevent and relieve heartburn associated with acid ingestion and sour stomach, should consider using other products approved for their condition.

NDMA is classified as a probable human carcinogen based on results from laboratory tests. NDMA is also a known environmental contaminant found in water and foods, including meats, dairy products and vegetables.

This recall follows a recent FDA statement about NDMA impurities detected in ranitidine medicines. The agency also recently alerted patients and health care professionals of Sandoz Inc.’s voluntary recall of prescription ranitidine hydrochloride capsules due to an NDMA impurity on Sept. 23.

What patients should know

• Not all ranitidine medicines marketed in the U.S. are being recalled.
• The FDA is not recommending individuals stop taking all ranitidine medicines at this time.
• Consumers taking over-the-counter ranitidine could consider using other over-the-counter products approved for their condition.
• Patients taking prescription ranitidine who wish to discontinue use should talk to their healthcare professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.

FDA’s actions

The FDA is continuing to test ranitidine products from multiple manufacturers and assess the possible effect on patients who have been taking the drug. Additionally, the FDA recently posted a testing method that can be used by regulators and industry to detect nitrosamine impurities in ranitidine.

The FDA will take appropriate measures based on the results of this ongoing investigation. Some manufacturers have chosen to stop distribution of ranitidine as a precautionary measure while the FDA and other international regulators conduct their investigations of the NDMA impurity.

The FDA is continuing to evaluate the safety of ranitidine and will provide more information as it becomes available.

Consumers and healthcare professionals should report any adverse reactions to ranitidine to the FDA's MedWatch program to help the agency better understand the scope of the problem:

• Complete and submit the report online.
• Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178.