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Congresswoman Rosa DeLauro

Representing the 3rd District of Connecticut

DeLauro Calls on FDA, HHS to Recall Drug Commonly Found in Zantac

December 18, 2019
Press Release

WASHINGTON, DC – (December 18, 2019) Today, Congresswoman Rosa DeLauro (CT-03) sent a letter to the Food and Drug Administration (FDA) Commissioner Stephen Hahn and the Department of Health and Human Services (HHS) Secretary Alex Azar to recall drugs containing ranitidine due to high levels of N-Nitrososdimethylamine (“NDMA”), a probable human carcinogen.

“Due to a historically very high perception of safety, ranitidine is heavily prescribed to adults and infants and sold over-the-counter. Yet, Valisure, an analytical pharmacy based in my District, has detected extremely high levels of N-Nitrososdimethylamine (“NDMA”), a probable human carcinogen, in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine,” wrote DeLauro. “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.”

“It is incomprehensible that FDA is fully aware of this fact, yet, it continues to allow this drug to remain on the shelves,” continued DeLauro. “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.”

A signed copy of the letter can be found here.

DeLauro serves as Chair of the House Appropriations Subcommittee that funds HHS, as well as the Vice-Chair of the House Appropriations Subcommittee that funds FDA.

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