Walgreens, CVS, and Rite Aid are pulling Zantac and generic versions of the heartburn drug off of their shelves over concerns that the medications may contain trace amounts of nitroso dimethylamine (NDMA), a chemical that has been linked to liver damage and cancer.
CVS announced on Saturday that it would be suspending sales “out of an abundance of caution.” A spokesperson for Walgreens said that the pharmacy would be pulling Zantac and generics while the FDA continues to review the products. Rite Aid is also in the process of removing these products from its shelves.
The decision to remove Zantac and its generic equivalents from shelves comes as major manufacturers of the generic form of the drug, ranitidine, announced recalls. Other countries have asked companies to halt distribution or have issued recalls.
The FDA has recommended that patients who want to stop taking ranitidine talk to their doctors about alternatives for the heartburn medication. The drug is commonly used to treat acid reflux as well as ulcers.
In South Korea, regulators have suspended sales of the drug. Bangladesh placed a temporary ban on drugs made with APIs from Dr. Reddy’s and India’s Saraca Laboratories, which have been shown to have elevated levels of NDMA in their ingredients. Canada has also requested that drugmakers stop sales of the drugs there.
The FDA issued an alert in September warning that it had determined that NDMA could be produced during the production of ranitidine drugs. At that time, the agency said that the amounts found in the drug were less than what would be found in common foods. The risks, the FDA said, appeared to be small.
The FDA is asking companies to test NDMA levels in their drugs and to send samples to the agency.
The issue with ranitidine was first discovered in June by Valisure, which analyzes drugs to verify their chemical components before shipping them to consumers.
