FDA Pulls Popular Heartburn Medication Zantac Over Cancer Concerns
On Wednesday, the U.S. Food and Drug Administration (FDA) officially issued a withdrawal request for ranitidine (brand name Zantac) after ongoing investigations raised red flags about a cancer-causing substance in the drug. Ranitidine is no longer FDA-approved for use in the United States.
⚠️FDA requests market withdrawal of all remaining prescription and OTC ranitidine (Zantac) products on the U.S. market. This means that ranitidine will not be available for use in the U.S. https://t.co/kfcW0wlHo6 pic.twitter.com/IvrLcmrMn5
— FDA Drug Information (@FDA_Drug_Info) April 1, 2020
Ranitidine is an over-the-counter or prescription medication for heartburn that was initially flagged by the FDA in 2019 after reports the medication was contaminated with N-nitrosodimethylamine (NDMA). NDMA is believed to be a cancer-causing agent in humans. After the FDA’s initial concerns about the medication, big box retailers like Walmart, CVS and Walgreens pulled ranitidine from shelves while waiting for further information.
The FDA issued its withdrawal recommendation on Wednesday after further studies showed that the levels of NDMA in the ranitidine samples themselves increased over time. As the medication sat on the shelf or was exposed to higher temperatures during distribution or handling, the FDA found that NDMA levels rose above the acceptable daily intake limit. For this reason, the FDA decided manufacturers, stores and pharmacies should pull the medication completely.
Manufacturers of the drug, some who voluntarily pulled the medication from the shelves in 2019, will receive a letter from the FDA requesting they pull the drug from the market. Patients are advised to stop taking these medications and if you’re taking prescription-strength ranitidine, to work with your doctor to find an alternative.
“We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a statement, adding:
We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured.
Header image via golibtolibov/Getty Images
Renée Fabian was the features editor at The Mighty. She has also written for The Washington Post, VICE, Healthline, Talkspace, The Fix, The Establishment, The Culture Trip, and GRAMMY.com, among others. Renée was named a 2019 AHCJ Comparative Effectiveness Research fellow, a 2020 USC Center for Health Journalism California fellow, and holds a master's degree in journalism from the University of Southern California and a master's degree in psychology from Antioch University Los Angeles. You can follow her on Twitter @ryfabian.
reneeyfabian