FDA Pulls Ranitidine Off the Market

April 1, 2020
Kenny Walter

Kenny Walter is an editor with HCPLive. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with R&D Magazine. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

Independent evaluations found NDMA levels increase over time and when stored in temperatures above room temperature.

The US Food and Drug Administration (FDA) announced they will be removing all prescriptions and over-the-counter ranitidine (Zantac) drugs from the market immediately due to consumer exposure to an unacceptable levels of N-Nitrosodimethylamine (NDMA).

The FDA determined that this impurity can increase over time and when stored at than room temperatures can result in unacceptable levels of the known carcinogen.

NDMA is a probable human carcinogen that the FDA has been investigating since 2019 when independent laboratory testing found the containment in ranitidine.

However, low levels of NDMA is often consumed in food s and water and is not expected to lead to an increase in the risk of cancer.

When sustained at higher levels of exposure it can increase the risk of cancer in humans.

In September, the FDA warned the public of the potential risks of ranitidine products.

New testing and evaluation conformed NDMA levels increase even under normal storage conditions and increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers.

The testing also showed the older the medication is, the greater the level of NDMA.

The FDA is sending letters to all ranitidine manufacturers requesting they withdraw the products from the market. The FDA is also advising consumers stop taking the medications and dispose of them.

Patients taking prescription ranitidine should speak with their health care providers.

“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,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”