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Another testing lab wants federal regulators to announce a full Zantac recall, indicating that the active ingredient in the heartburn drug can generate dangerous levels of the cancer-causing impurity N-nitrosodimethylamine (NDMA) after storage that exposes the drug to heat as low as 77 degrees Fahrenheit.
Emery Pharma is the latest independent laboratory to file a Citizen’s Petition with the FDA to have Zantac pulled from the market, after the on-line pharmacy Valisure filed a similar request in September 2019, following the discovery of Zantac NDMA problems across all lots of they tested.
According to Bloomberg News, Emery Pharma tested three samples of ranitidine, the generic name for Zantac, and found that five days of exposure to heat over 158 degrees Fahrenheit (70 degrees Celsius) resulted in the pills containing more than the FDA’s 96 nanogram daily limit of NDMA. At temperatures of just 77 degrees Fahrenheit (25 degrees Celsius) the pills generated 25 nanograms over a period of 12 days.
The pharmacy noted this means that users could be taking NDMA-laced pills if they happen to leave them in a hot car for several days, or otherwise store them in a warm location for too long. The cancer-causing chemical may also develop during shipment and storage at retail locations, since the current products did not contain any warnings about the importance of temperature control.
Zantac (ranitidine) has been a top selling heartburn and acid reflux drug since it was introduced in the early 1980s, but most versions have been removed from the market over the past few months, after Valisure found that pills in their pharmacy contained levels of NDMA that may pose a risk to human health. However, several forms of Zantac remain on the market, and many consumers remain unaware that Zantac in their medicine cabinet may be recalled.
The online pharmacy Valisure filed a Citizens Petition with the FDA in September, calling for all versions of Zantac to be recalled from the market, indicating that NDMA was created due to the inherent structure of the active pharmaceutical ingredient in the heartburn drug, ranitidine.
Valisure’s testing indicated Zantac contained up to 29,000 times the levels of NDMA the FDA considered permissible. While the FDA has questioned some of Valisure’s procedures, the agency conducted its own testing and agreed that the levels of NDMA were still excessively high.
According to Bloomberg News, Valisure asked Emery Pharma to test the drug as well, resulting in Emery also filing a Citizen’s petition with the FDA to have all forms of Zantac removed from the market.
The Emery Pharma petition has not yet been circulated to the public, as FDA officials indicate they are reviewing the petition and will respond.
In recent months, dozens of Zantac lawsuits have been filed by individuals throughout the United States, each involving similar allegations that plaintiffs developed kidney cancer, stomach cancer, bladder cancer, colorectal cancer, esophageal cancer or other cancers in the digestive tract, as ranitidine contained in Zantac broke down into NDMA inside the body.
As lawyers continue to investigate potential Zantac claims over the coming months and years, it is widely expected that thousands of lawsuits will be brought throughout the federal court system.