U.S. Congresswoman Calls on FDA to Order Zantac Recall

Published on December 20, 2019 by Sandy Liebhard

A prominent lawmaker is calling on the U.S. Food & Drug Administration (FDA) to order a recall of all Zantac and ranitidine heart burn drugs, amid concerns that the products could be contaminated with a cancer-causing chemical.

FDA Failure to Order Zantac Recall “Incomprehensible”

In a December 18^th letter to FDA Commissioner Stephen Hahn and the Department of Health and Human Services (HHS) Secretary Alex Aza, Rep. Rosa DeLauro, a Democrat from Connecticut, noted that Valisure, an online pharmacy based in her state, had detected extremely high levels of N-Nitrososdimethylamine (NDMA), a probable human carcinogen, in every lot of Zantac and ranitidine tested.

“It is my understanding that ranitidine’s carcinogenicity has not been fully vetted by the FDA. Valisure’s data, in combination with four decades of scientific research, strongly suggests that ranitidine is a fundamentally unstable molecule and all products containing this drug have a risk of cancer,” DeLauro writes.

“It is incomprehensible that FDA is fully aware of this fact, yet, it continues to allow this drug to remain on the shelves,” the letter continues. “FDA’s failure to stop companies from selling ranitidine makes the United States government complicit in exposing infants and adults to the risk of cancer. I urge you to act and uphold the mission of the FDA, as well as the Department of Health and Human Services, by immediately removing ranitidine from shelves and banning all sales.”

FDA Actions on Contaminated Zantac

The FDA first disclosed the possible presence of NDMA in Zantac on September 13^th. The chemical has been designated a probable human carcinogen by the U.S. Environmental Protection Agency, as animal testing suggests exposure may increase the risk for cancer, especially gastrointestinal, liver, and kidney tumors.

Despite the cancer concerns, the FDA did not order a Zantac recall, and instead advised consumers using over-the-counter ranitidine products to consider switching to another heart burn treatment. However, those taking prescription versions of ranitidine should not stop taking their medication without first talking with their doctor, as doing so could greatly worsen the condition being treated.

The FDA initially blamed the high levels of NDMA detected by Valisure on the company’s high- temperature testing method. But later, the agency did acknowledge that some samples of Zantac and ranitidine contained NDMA above the FDA’s acceptable daily limits of 96 nanograms.

The FDA has since ordered new testing to determine if the carcinogen is formed when ranitidine is exposed to chemicals that naturally occur during digestion. Drug makers have also been asked to test all lots of the medication, inform the FDA if any are found to contain more than 96 nanograms of NDMA, and ensure they are not put on the market.

While the FDA has declined to order a Zantac recall, numerous pharmaceutical companies have opted to recall their ranitidine products. Various retailers, including CVS, Walmart, Rite-Aid, and Walgreens, have also pulled all prescription and over-the-counter ranitidine-containing medicines from store shelves.