SNY Sanofi

By Maria Armental and Colin Kellaher 

U.S. health regulators ordered that the popular heartburn drug Zantac and other ranitidine generics be pulled from the market immediately, citing a potential public-health risk.

The Food and Drug Administration had found elevated levels of a possible cancer-causing chemical that led to voluntary recalls starting last year, including by French health-care giant Sanofi SA.

On Wednesday, the FDA said levels of the potential carcinogen in some ranitidine products increases over time, even under normal storage conditions, and that it was found to increase significantly in samples stored at higher-than-room temperatures, including temperatures the product may be exposed to during distribution and handling by consumers.

The agency said that all prescription and over-the-counter ranitidine products must be pulled off shelves and that consumers stop taking the medications immediately and switch to approve alternatives, following consultation with health-care professionals.

"We didn't observe unacceptable levels of NDMA in many of the samples that we tested," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research said, referring to the chemical N-Nitrosodimethylamine. "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."

The FDA said that testing at this point hasn't found NDMA in famotidine, (brand name Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

Ranitidine was first developed under the brand name Zantac by British drugmaker GlaxoSmithKline PLC in the 1980s, although it later sold the U.S. brand rights to Sanofi. Zantac has since lost patent protection, and it is now produced by several generic drug companies, too.

Sanofi recalled branded Zantac products in October, when some preliminary tests suggested the product may contain NDMA. A spokeswoman said in a statement that the company "takes this issue seriously and continues to work closely with the FDA to evaluate any potential safety risks associated with Zantac."

Write to Maria Armental at maria.armental@wsj.com and Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

April 01, 2020 13:21 ET (17:21 GMT)

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