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What’s behind the recent recall of Zantac?

On Behalf of | May 8, 2020 | Firm News

When you have bad heartburn, you just want instant relief. That’s one reason why Zantac has become a popular over-the-counter medication; users can feel heartburn relief within an hour. However, on April 1, the FDA issued a recall of Zantac off U.S. pharmacy shelves because it contains N-nitrosodimethylamine (NDMA), a known carcinogen.

The FDA’s recall comes after an ongoing investigation of NDMA. The FDA investigation, which began in summer of 2019, showed NDMA can break down over time and become more potent when stored at high temperatures. NDMA is known to cause gastric and colorectal cancers and is toxic to the liver.

The FDA said in its recall announcement that it hadn’t found any unacceptable amounts of NDMA in ranitidine products (including Zantac) it tested. However, the FDA wanted to recall Zantac because the federal agency wasn’t sure how long boxes that contained NDMA had been on the shelves.

The federal agency also warned consumers of Zantac to stop taking the medication and dispose of it properly.

Patients who were taking the prescription form of ranitidine were advised to consult their doctors about alternative medications to treat acid reflux. The FDA also reported that it hadn’t found NDMA in other over-the-counter heartburn medications, including Pepcid, Nexium, Prevacid or Prilosec.

In the short time since the recall, some longtime Zantac users already have filed lawsuits over the product’s dangerous ingredients. Because it can take years for cancer to show up in patients, likely more Zantac users will be filing suits for years to come as the result of the FDA’s findings.