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Zantac
10 Nov

By pharmatrax

Category: News

FDA: Zantac carcinogens no more dangerous than ‘grilled or smoked meats’ No Comments

FDA: Zantac carcinogens no more dangerous than ‘grilled or smoked meats’

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Drugmakers may be recalling the heartburn med Zantac around the world, but the FDA wants consumers to stop worrying. Higher-than-recommended levels of a possible carcinogen in the pills are no more dangerous than a grilled ribeye, the agency said Monday.

Testing of recalled lots of branded and generic Zantac showed levels of a contaminant known as N-Nitrosodimethylamine (NDMA) that were as much as nine times greater than the FDA’s recommended limit––but the agency pooh-poohed the health risk in a release.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said despite NDMA levels that were at times significantly above the acceptable limits, the amount of the compound found in the drugs was comparable to levels found in “grilled or smoked meats.” Moreover, the FDA concluded that consuming Zantac didn’t cause NDMA to form in the stomachs of patients, as had been previously posited.

“We understand the concern we’ve been hearing from parents and pediatricians and we’ll continue to investigate,” Woodcock said.

The agency said it was still requesting manufacturers continue to test lots of Zantac (ranitidine) as well as antacid nizatidine, marketed under the brand name Axid. The FDA said it was also still testing injectable ranitidine for possible contamination.

Drugmakers and retailers have been pulling lots of generic and brand Zantac off the shelves after online pharmacy Valisure alerted the FDA and the industry to the presence of NDMA in the heartburn medicines in September. Valisure also filed a Citizen Petition with the FDA seeking to have the agency pull ranitidine drugs from the market and create viable tests for NDMA in them. NDMA is one of three impurities the FDA discovered last year in sartan blood pressure meds that led to a global recall.

In mid-October, drugmakers including GlaxoSmithKline––the original producer of branded Zantac––Sanofi, Teva, Dr. Reddy’s Laboratories and others opted to pull the drug off the market. Retailers including Wal-Mart, CVS, Walgreens and Rite Aid also decided to clear the drugs off their shelves.

On Monday, Dr. Reddy’s said it was provisioning 40 million crore ($5.7 million), including possible refund liabilities, after it decided to join the Zantac recall, according to Business Standard.

Last week, the FDA cleared antacid alternatives for patients, saying that preliminary tests of Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole) found no NDMA.

Source: https://www.fiercepharma.com/pharma/fda-zantac-carcinogens-no-more-dangerous-than-grilled-or-smoked-meats

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