On Wednesday, April 1, 2020, the U.S. Food and Drug Administration requested that manufacturers recall all prescription and OTC ranitidine drugs from the market immediately. The agency has determined that an impurity increases over time, particularly in warm storage temperatures, resulting in unacceptable exposure to the carcinogen NDMA. While some samples tested did not contain dangerous levels of an impurity, the FDA has decided that the product, such as Zantac should become unavailable as they continue to investigate.
History of Zantac Recall
Concerns about nitrosamines like NDMA in the human body date back to GlaxoSmithKline’s potentially flawed internal safety studies on Zantac in the 1980s. Decades later, a 2004 study linked ranitidine with the development of bladder cancer, and a 2016 Stanford study found NDMA levels in the urine of Zantac users that exceeded 47,000 nanograms.
More recently, the FDA’s own studies revealed potential contamination. They explained in their statement: “The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.”
- September 13, 2019 – The FDA alerts health care providers of NDMA found in test samples of ranitidine.
- September 24, 2019 – The FDA announces a voluntary recall of Sandoz ranitidine capsules.
- October 2019 – February 2020 – Ranitidine tests continue. Generic manufacturers voluntarily recall ranitidine.
- April 1, 2020 – The FDA recommends that all ranitidine be voluntarily recalled while the investigation continues.
What Is the Risk of Taking Zantac?
Nitrosodimethylamine (NDMA) is a “probable human carcinogen,” which means it could cause cancer. While low levels of NDMA naturally found in soil, water, and grilled foods are not expected to increase your cancer risk, higher levels of exposure from medication like Zantac may pose an unacceptable risk.
What Should You Do If You Use Ranitidine?
If you’ve been using Zantac to treat stomach ulcers, esophagitis, GERD, or Zollinger-Ellison syndrome, you’ll find it is no longer available in pharmacies – either in the over-the-counter format or prescription strength. Abruptly ceasing use of the product could cause an influx of acid into your stomach, so it’s best to consult your doctor.
Safe, non-ranitidine alternatives to Zantac to help manage your condition includes:
- Famotidine (Pepcid)
- Cimetidine (Tagamet)
- Esomeprazole (Nexium)
- Lansoprazole (Prevacid)
- Omeprazole (Prilosec)
If you have Zantac at home, be aware that it is not on the FDA’s “flush list.” Therefore, you must return the unused medication to a nearby drop-off location or discard the medicine in your trash at home in a sealed Ziploc bag with kitty litter or coffee grounds.
Are Ranitidine Users Suing?
One woman from Illinois has already filed suit, alleging that her stomach cancer was directly caused by her use of Zantac from 2000-2018. Her lawsuit claims that the increased NDMA level is not related to storage or a manufacturing impurity, but rather, is a defective function of the ranitidine molecule itself as it breaks down in the digestive tract.
The U.S. Judicial Panel on Multidistrict Litigation recently consolidated 144 Zantac lawsuits into MDL-2924 before Judge Robin L. Rosenberg into the U.S. District Court for the District of Florida for the streamlining of pretrial proceedings.
If you or a loved one received a recent cancer diagnosis after years of Zantac or generic ranitidine use, contact Showard Law Firm to explore your legal options. Consultations are always free, and it costs you nothing out-of-pocket to pursue your claim.
