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FDA Says that Drug Makers Must Stop Ranitidine Sales

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) told drug makers who sell ranitidine-based medications to stop. Ranitidine is the generic name for the active ingredient in acid-reducing drugs like Zantac. Zantac is known as the most-prescribed drug across the globe in 1987, according to Wired. Now the FDA has asked companies selling […]

Fda says that drug makers must stop ranitidine sales

Drug makers must stop ranitidine sales

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) told drug makers who sell ranitidine-based medications to stop. Ranitidine is the generic name for the active ingredient in acid-reducing drugs like Zantac. Zantac is known as the most-prescribed drug across the globe in 1987, according to Wired. Now the FDA has asked companies selling Zantac or its generic equivalent to stop selling their ranitidine-based products, whether they are over-the-counter or by prescription. The FDA fears that ranitidine contains N-nitrosodimethylamine, otherwise known as NDMA, which is a carcinogen. The FDA indicated in its correspondence with drug makers that ranitidine has an impurity when combined with heat that forms NDMA.

Sanofi pulled Zantac in 2019 on the heels of the FDA’s finding that NDMA is a by-product of ranitidine. Generic manufacturers of ranitidine-based drugs also pulled their products. Additionally, stores that operate nationally, such as Walgreen’s, CVS, and Walmart, pulled their over-the-counter ranitidine products. Notwithstanding, a Sanofi spokesperson said that the company recalled their Zantac over-the-counter line of medications despite twenty years of selling Zantac.

Drugs contaminated with NDMA have been found in other medications in addition to ranitidine. High blood pressure medications made with valsartan, irbesartan, and valsartan have been linked to positive NDMA findings. The diabetes generic medication metformin is also connected to elevated levels of NDMA.

NDMA is a chemical that was popular for use in rocket fuel and lubricants. NDMA is also a by-product of drinking water chlorination, the production of pesticides, foundries, tanneries, rubber, and the production of dye as well.

NDMA is also a by-product created by the digestion of foods with either nitrites or nitrates. Foods containing nitrites or nitrates include smoked or grilled meats, bacon, and can be found in vegetables and fruits as well.

The FDA, taking its cue from the U.S. Environmental Protection Agency, claims NDMA is a probable carcinogen in humans and has been proved to cause cancer in animals.

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