Zantac Litigation

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Zantac Lawsuit Signed Cases

Zantac is a medication used to prevent ulcers and acid reflux but a substance found in it may potentially cause cancer. The federal Food and Drug Administration (FDA) has stated a potentially cancer-causing chemical had been found at low levels in prescription and over-the-counter versions of Zantac. A naturally occurring but potentially cancer causing compound N-nitrosodimethylamine (NDMA) was discovered in low but “unacceptable” levels in random samples of the drug.

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The FDA and Health Canada issued public statements in September 2019 warning that since some medicines using ranitidine were found to contain NDMA, including over the counter Zantac, manufacturers should conduct additional testing, consumers should find alternatives and retailers should stop selling it. The maker of Zantac, France-based Sanofi, issued a voluntary recall of the drug a month later.

The company stated that evaluations of ranitidine, the drug’s active ingredient, and the finished product are ongoing, according to a company press release. Sanofi found “inconsistencies in preliminary test results of the active ingredient used in the U.S. and Canadian products” then decided to recall the over the counter version of the drug. Sanofi “encourages anyone using Zantac OTC to speak with their health care providers or pharmacists if they have any additional questions.”

Zantac, ranitidine, NDMA and cancer

Ranitidine in prescription drugs is used to treat ulcers to prevent them from returning after they healed. It’s also used to treat stomach and throat (esophagus) problems such as erosive esophagitis, gastroesophageal reflux disease-GERD and Zollinger-Ellison syndrome. It reduces the amount of acid produced in the stomach. Over the counter ranitidine products are used to prevent and treat heartburn and other symptoms caused by too much acid in the stomach (acid indigestion).

NDMA is found in industrial and natural processes. It’s classified by the federal Environmental Protection Agency as a probable carcinogen (something that causes cancer) because it modifies cells’ DNA, which can cause it to mutate. As time goes on and the mutations continue, cells can become cancerous. Pharmaceutical companies maintain that though NDMA has been shown in laboratory experiments to increase the risk of cancer in animals, there is no reliable evidence how much NDMA may increase the cancer risk in humans.

Unstable ingredient may poison Zantac users

CBS News found that the problem with Zantac and NDMA may not be a stray, inactive ingredient in the finished drug, like valsartan, but its active ingredient. At a lab in Connecticut, Valisure, researchers tested drugs from its online pharmacy to check for purity and quality. The over the counter version of Zantac stood out due to its high levels of NDMA.

Valisure CEO David Light stated the drug appeared to be a “fundamentally unstable molecule” that under various conditions in the lab and in the human body can form NDMA. The ranitidine/NDMA connection was first suggested three years ago in published research. Ten volunteers were given a Zantac tablet and their urine was tested afterward. It found NDMA levels more than 400 times greater than what the FDA considers acceptable.

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