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Following an FDA petition filed earlier this year to recall Zantac and other ranitidine-based drugs from the market, due to the risk that the active ingredient may produce cancer-causing chemicals, a U.S. lawmaker indicates that the FDA should require that all versions of the widely used heartburn medications be removed from store shelves nationwide, saying the medication poses a risk to public health and safety.
Congresswoman Rosa L. DeLauro, of Connecticut, sent a letter (PDF) on December 18 to Dr. Stephen Hahn, the recently appointed commissioner of the FDA, and Alex Azar, secretary of the Department of Health and Human Services, calling for a national Zantac recall, rather than allowing a slow trickle of individual recalls to be issued by different drug makers as they confirm that drugs contain unacceptable levels of the carcinogen N-Nitrosodimethylamine (NDMA)
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 pills were found to contain 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.
DeLauro questioned the FDA’s decision in not just pulling all ranitidine products from the market, noting that the online pharmacy, Valisure, which first revealed the presence of NDMA in Zantac in September 2019, found the carcinogen in every lot it tested.
“It is incomprehensible that FDA is fully aware of this fact, yet, it continues to allow this drug to remain on the shelves,” she wrote. “FDA’s failure to stop companies from selling ranitidine makes the United States government complicit in exposing infants and adults to the risk of cancer. I urge you to act and uphold the mission of the FDA, as well as the Department of Health and Human Services, by immediately removing ranitidine from shelves and banning all sales.”
Valisure filed a Citizens Petition with the FDA in September, calling for all versions of Zantac to be recalled from the market, after testing confirmed 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.
Since the information was publicly released, 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 along the digestive tract, as ranitidine contained in Zantac broke down into NDMA inside the body.
Just a day before Representative DeLauro’s letter, Glenmark issued a generic ranitidine tablet recall consisting of 1,840 lots of 150 mg and 300 mg tablets due to the presence of NDMA.
The recalled 150 mg tablets were sold in bottle packs of 60, 100 and 500 tablets; and the 300 mg tablets were sold in bottles of 30, 100 and 250 tablets.
Customers who purchased the recalled tablets can call Qualanex at 1-888-504-2012 to arrange for their return. Those with questions can call Glenmark Drug Safety at 1-888-721-7115.