FDA Requests Removal of Zantac from the Market

The U.S. Food and Drug Administration announced yesterday that it is requesting Sanofi, the manufacturer of Zantac, to remove and withdraw all prescription and over-the-counter Zantac (ranitidine) drugs immediately from the market. This comes after a lengthy investigation which revealed that a contaminant known as N-nitrosodimethylamine (NDMA) is prevalent in these medications (Zantac). The NDMA contaminant increases over time, particularly when stored at higher than room temperatures and may expose consumers to unsafe levels of this contaminant.  NDMA is a known human carcinogen (a substance that can cause cancer). Ranitidine products will no longer be available for new or existing prescriptions or over-the-counter use in the United States.

Recent FDA testing and evaluation showed that NDMA levels increase in rantidine even under normal storage conditions. NDMA has been found to increase significantly when stored at higher temperatures, including during the transportation and distribution process of getting the drug into the marketplace. The testing also showed that the older the product is, the greater the level of NDMA. These conditions raise the level of NDMA in the ranitidine above safe levels.

           “The FDA is committed to ensuring that the medicines Americans take are safe and effective.  We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. We didn’t observe unacceptable levels of NDMA in many of the tested samples. However, since we don’t know how or for how long the products might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured, “said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

The FDA also advises consumers to immediately stop taking any form of Zantac product and to dispose of any remaining tablets or liquid in their possession. Patients who are taking prescription forms of the medication should consult with their physicians regarding a safer alternative.  Other over-the-counter choices may include Pepcid, Tagamet, Nexium, Prevacid or Prilosec. 

In a statement, Sanofi, the manufacturer of the brand name version of Zantac indicated it had originally recalled the product in October and that consumers were advised to return or destroy the product.  “We take this issue seriously and continue to work closely with the FDA to evaluate any potential safety risk associated with Zantac,” the company said.  “At Sanofi we stand by the longstanding science that supports the safety of Zantac OTC products, which have been used by consumer for over decades.”  In light of the recent COVID -19 crisis, patients are encouraged to dispose of the products and not attempt to return them to the pharmacy.

If you or a loved one have been recently diagnosed with cancer and have been a significant user of Zantac, call the attorneys at Ennis & Ennis, P.A. for a free consultation or visit us online at www. Ennislaw.com


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