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Heartburn Drug Manufacturer Sanofi Could Be Forced To Regularly Test Zantac For Carcinogens

Measures have been put in place in Canada that could serve to guide the US FDA to require ongoing ranitidine testing

Friday, October 16, 2020 - Anti heartburn and acid reflux medicine Zantac was being used by around 15 million Americans in 2019 before the FDA ordered Sanofi to stop selling and recall the medicine. Ranitidine (Zantac) is intent on returning to the market but to do so may have to adhere to a strict schedule of ongoing drug testing. Companies selling ranitidine heartburn medicine may have to test for and certify the levels of NDMA in the product and recall any that exceed a certain limit. The current FDA benchmark for acceptable NDMA is 96 nanograms per day or daily Zantac tablet. Online testing pharmacy Valisure found levels of NDMA many thousands of times greater prompting the ranitidine cancer panic. NDMA is a common compound found in food and water but in higher quantities can cause cancer tumors in laboratory test animals.

Lawsuits against Sanofi, the maker of anti-heartburn, and acid reflux medicine Zantac continue to site many different types of cancer that the drug can cause. According to, the latest complaint is by Florida resident Charles York alleging that using Zantac regularly and for more than a year caused him to develop cancer of the tonsils. Other lawsuits claim that Zantac has caused stomach, bladder, esophageal, breast, colon, intestinal, and other cancer. Zantac cancer attorneys represent those who have used ranitidine in the past and have been diagnosed with cancer. The company was notified in the late 1990s that Zantac could contain levels of NDMA high enough to contribute to developing cancer, yet did nothing to warn consumers. The company continues to deny that it had a responsibility to test the drug regularly for changes to the chemical composition of Zantac that could result from high tablet storage temperatures. The FDA is now considering putting into place measures, like those in Canada, that would require any company selling ranitidine to test their products regularly after sold to retailers.

Health Canada, Canada's equivalent of the US FDA, has outlined steps to be taken by any company that wishes to sell ranitidine products in their country going forward. The agency requires that companies conform to the following stipulations. Companies must, "continue to test every batch of ranitidine product before releasing it and test it regularly throughout its shelf life; conduct more frequent testing if NDMA is detected within a certain range below the accepted limit, to enable faster detection of any increases in NDMA; conduct additional testing to evaluate the potential for NDMA formation under different storage conditions (e.g., above room temperature); and provide all of the above test data to Health Canada, along with any information to help further evaluate the potential formation of NDMA from ranitidine in the body," according to Healthy If you or a loved one have cancer and have taken Zantac, you may be able to file a claim against Sanofi. Many believe that the company had an obligation to warn consumers of the risks of taking the heartburn medication.

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OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. The Onder Law Firm has won more than $300 million in four talcum powder ovarian cancer lawsuits in St. Louis. Law firms throughout the nation often seek its experience and expertise on complex litigation.

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