Does Zantac (ranitidine) cause a potentially cancer-causing chemical to form in the body once the drug’s ingested?
That’s what the U.S. Food & Drug Administration (FDA) is now trying to determine, as its investigation into contaminated heartburn medications apparently enters a new phase.
The FDA warned Zantac and other ranitidine-containing drugs might be contaminated with N-nitrosodimethylamine (NDMA) on September 13th. The regulator learned of the problem from Valisure, an online pharmacy that detected NDMA in every sample of Zantac and ranitidine it tested, and often at amounts far above the FDA’s recommended daily limits.
The agency initially suggested that Valisure’s high temperature testing method was to blame for “unacceptable” levels of NDMA detected in Zantac. But the company maintains that unstable ranitidine molecule actually forms the compound when subjected to the conditions created by digestion.
Last Friday, an FDA spokesperson told Reuters that the agency is now “working to understand what happens to NDMA levels in the body, after ranitidine has been exposed to acid in the stomach.”
Valisure’s Chief Executive David Light seemed pleased that the FDA investigation is finally heading in this direction, telling Reuters that the company’s data suggests ranitidine produces NDMA levels in the body that “are many magnitudes of order higher than what’s been talked about in the contamination.”
The U.S. Environmental Protection Agency classifies NDMA as a probable human carcinogen, as animal testing has linked the compound to an increased risk of kidney, liver, colorectal, and gastrointestinal cancers.
Valisure urged the FDA to order a Zantac recall, but the agency has so far declined to do so. Nevertheless, various pharmaceutical companies, including Sanofi-Aventis and GlaxoSmithKline, have decided on their own to suspend sales or recall ranitidine products in recent weeks. On October 23rd, generic drug makers Dr. Reddy’s and Perrigo Company were the latest to pull their products from the market.
CVS, Walmart, Walgreens, and other retails have also chosen to remove Zantac and ranitidine-containing medications from store shelves.
Last week, the FDA confirmed that preliminary tests of alternative heartburn drugs, including Pepcid, Prilosec, and Nexium, had not detected any NDMA. The agency has advised consumers who use over-the-counter versions of Zantac or ranitidine to consider switching to another heartburn drug. However, those using prescription versions should not stop taking their medication without talking to their doctor, as doing so could worsen their condition.
In recent weeks, a growing number of Zantac lawsuits have been filed in courts around the United States, including personal injury claims for cancer, as well as class action lawsuits that seek economic damages and medical monitoring for consumers who allegedly ingested tainted drugs.
Zantac has been on the market for over 30 years, and at one time was the world’s most popular medication. While the litigation involving Zantac and ranitidine is still in its early stages, many legal experts believe hundreds of similar cases could be filed in the coming months.
“There are 800,000 people diagnosed each year with the cancers we’re talking about,” one Zantac lawyer told Law.com. “How many are caused by ranitidine or Zantac? I’m not sure. But even if you’re conservative, and just say 10%, you’re looking at over 80,000 cancers a year caused by this drug.”