FDA Requests Zantac Be Removed from Market

On April 1, 2020, the U.S. Food and Drug Administration (FDA) announced the request for all prescription and over-the-counter (OTC) ranitidine drugs to be pulled from the market immediately. This request came after an ongoing investigation determined the N-Nitrosodimethylamine (NDMA) in Zantac has the potential to cause health problems.

Six months ago, independent testing began to determine if ranitidine could break down into NDMA. According to the test results, the impurity in some ranitidine products increases over time and when stored at higher than room temperatures. As a result of this withdrawal request, Zantac and other ranitidine products will not be available for new or existing prescriptions or OTC use in the United States.

While the agency has not ordered a mandatory recall, it anticipates full cooperation given the safety issues at hand. According to Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, ranitidine is not defective, but it can become defective when stored under stressful conditions for the product.

Because of this, there are concerns about potential long-term effects for those who have taken it: “The FDA is committed to ensuring that the medicines Americans take are safe and effective. […] 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.”

NDMA is a probable human carcinogen. While low levels of NDMA are commonly ingested from foods and water, low levels are not expected to lead to cancer. Sustained higher levels, however, could lead to an increased risk of cancer. While the FDA only found low levels of NDMA in ranitidine products, they are pulling the medication because they do not have enough scientific information to recommend individuals to continue or stop taking the medication.

For those who have taken Zantac and are looking for an alternative, the FDA is suggesting famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), or omeprazole (Prilosec). Prior to making any medication changes, it’s recommended patients contact their primary care physicians.

If you were prescribed Zantac or you took the over-the-counter version and are now suffering from a cancer diagnosis, you may be able to take legal action. Thomas Law Offices will investigate your situation and determine if you’re eligible for compensation to cover your losses. Contact us today for more information.