FDA Calls for Immediate Removal of Zantac From Market | Levin Papantonio - Personal Injury Lawyers

FDA Calls for Immediate Removal of Zantac From Market

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 immediately pulled from the market.

This action came amidst the FDA’s ongoing investigation, which concluded that storing this drug at “higher-than-normal temperatures” elevates levels of a probable human carcinogen within the drugs. The federal agency 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.”

It Started Last Summer

Zantac, a popular drug that is prescribed by doctors and sold over the counter (OTC) in drugstores, contains the active ingredient ranitidine. In the summer of 2019, the FDA began investigating ranitidine after drug-testing company Valisure reported the drug contained high concentrations of the contaminant N-nitrosodimethylamine (NDMA), which the U.S. Environmental Protection Agency classifies as a probable human carcinogen.

Things Began to Escalate in the Fall

In September 2019, major retailers like Walgreens, CVS Pharmacy, and Walmart stopped stocking and selling Zantac in response to the FDA’s warning that it possibly contained cancer-causing elements.

David Light, founder and CEO of Valisure, whose mission is “to bring transparency and increased quality to the pharmaceutical industry,” told National Public Radio (NPR) last October of test results showing the drug could degrade into NDMA by itself, “either in the tablet or actually in the human body.”

That same month, Zantac manufacturer Sanofi voluntarily recalled Zantac products that had been sold OTC in Canada and the United States.

FDA Stepped It Up Further on April 1, 2000

After reaching its decision, the FDA began sending letters to ranitidine manufacturers, asking them to pull their products from the market. They also urged consumers to immediately cease use of the OTC medicine and dispose of any remaining product in their medicine cabinets.

Patients using prescription forms of the drug are told to speak to their physicians before they stop taking it.

SOURCES:

  1. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market
  2. https://www.epa.gov/sites/production/files/2014-03/documents/ffrrofactsheet_contaminant_ndma_january2014_final.pdf
  3. https://www.cnn.com/2020/04/01/health/zantac-fda-remove-from-market-bn/index.html
  4. https://www.npr.org/2020/04/01/825441284/fda-says-zantac-should-be-pulled-from-market-citing-cancer-risk