On April 1, 2020, the U.S. Food and Drug Administration (FDA) announced its request that all Zantac brand heartburn drugs, prescription and over the counter, be pulled from the market immediately. The agency concluded that a potential cancer-causing contaminant known as N-Nitrosodimethylamine (NDMA) can build up when Zantac products are stored for long periods of time or at higher-than-normal temperatures.
INVESTIGATION BEGAN SUMMER OF 2019
This is the latest action after the FDA began investigating ranitidine, an active ingredient in the popular heartburn drug Zantac, in the summer of 2019. The investigation began after an independent laboratory found high concentrations of NDMA in ranitidine. Although low levels of NDMA are commonly ingested in the diet, these levels would not be expected to lead to an increase in the risk of cancer. However, higher levels of exposure may increase the risk of cancer in humans.
THINGS ESCALATED IN THE FALL
In September, the FDA warned the public of the potential risks of ranitidine products and suggested consumers consider alternative OTC and prescription treatments as it continued its investigation. Shortly after the warning, major retailers like CVS, Walgreens, and Walmart pulled the product from their shelves in response to the FDA’s warning that it possibly contained cancer-causing elements. In October, Sanofi, the manufacturer of Zantac, voluntarily recalled Zantac products sold in Canada and the United States.
FDA TAKES DRASTIC MEASURE ON APRIL 1, 2020
New FDA testing and evaluation confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers. The elevated levels of the carcinogen found in the testing was deemed to pose a “risk to public health.” The FDA determined that, because there is no way to know how the drugs currently in the market are being stored, their presence and use poses a “risk to public health.”
After reaching its decision, the FDA sent letters to all manufacturers of ranitidine requesting they withdraw their products form the markets. They also urged consumers to immediately stop use of the OTC medicines and dispose of any remaining product in their medicine cabinets. Patients using the prescription forms of the drug are told to speak to their physicians before they stop taking it.
DEDICATED REPRESENTATION FOR PEOPLE INJURED BY DANGEROUS PRODUCTS
As consumers, we invest in products we trust. When a company violates that trust and sells a product that causes illness or injury, victims are left feeling confused, angry, and afraid.
At Grewal Law, PLLC, it is our mission to support victims of unsafe products, especially those that can result in long-term and life-threatening disease. If you or someone you love is suffering from cancer, and you suspect the cancer was caused by a ranitidine product, please contact our award-winning attorneys. We are here to fight for you, and we’ll do everything in our power to recover the compensation you deserve.
If you have any questions about ranitidine product (including Zantac) lawsuits, please call our award-winning attorneys at (855) 215-9899, who are available 24/7 to speak with you. Our consultations are always free.
A Graduate from the Florida State University College of Law, Leon Walsh, Jr. spent several years in Florida as an assistant public defender as well as working for a civil litigation firm where he gained valuable first-chair jury trial experience in both state and federal courts. Mr. Walsh now works for Church Wyble, PC in Northville, Michigan where he focuses on medical malpractice and complex personal injury claims.