On April 1, 2020, the U.S. Federal Drug Administration (FDA) announced it was requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. Ranitidine, sold as Zantac and generic equivalents, is used to treat ulcers and acid reflux.
This action is the latest step in ongoing research investigating N-Nitrosodimethylamine (NDMA), a probable cancer-causing substance found in ranitidine. Low levels of NDMA are present in ranitidine as well as in food and water. However, FDA testing demonstrated that levels of NDMA significantly increased when ranitidine was stored at higher temperatures. The testing also found that older ranitidine products had higher NDMA levels. The FDA concluded that the risks associated with higher temperatures and product age could raise the level of NDMA above acceptable limits.
Concerns surfaced last September, when independent and FDA testing found the low levels of NDMA in ranitidine. At that time, CVS, Walgreens, and Walmart announced they would stop selling Zantac and generic equivalents. The April 1st withdrawal request came after more recent FDA testing uncovered the connection between increased NDMA and higher temperatures and product age.
What should consumers do?
It’s important to note that while there is enough evidence to warrant withdrawing product, experts say that NDMA may cause cancer only after exposure to high doses over a long period of time. NDMA was also found in certain heart medications in 2018, leading to recalls of a number of products.
The FDA advises consumers to stop taking any ranitidine products they still have, though they should talk with their health care professional before doing so. A health professional can recommend and/or prescribe other medications known to be free of NDMA, as well as suggest diet and other modifications that may help ease the condition. Because of current COVID-19 concerns, the FDA recommends consumers do not attempt taking back their existing supply of ranitidine, and instead dispose of it by following these steps.
There are effective alternatives to ranitidine that work in much the same way. The FDA has not found NDMA in these drugs: