Health Canada is recalling some Axid (nizatidine) capsules because of the presence of N-nitrosodimethylamine (NDMA), a probable human carcinogen.
“Test results show that NDMA levels may increase over time for some nizatidine products,” Health Canada said in a notice dated May 1st. “The NDMA levels in the two lots being recalled are not higher than acceptable limits at this time, but they could increase with time.”
The recalled Axid capsules were manufactured by the Pendopharm Division of Pharmascience Inc. and include lot numbers 616927 and 617088, both of which expire on 31-08-2020.
“Individuals taking a prescription nizatidine drug, including a recalled product, should not stop taking it unless they have spoken to their health care provider and obtained alternative treatment, as the risk of not treating the condition may be greater than the risk related to NDMA exposure,” the notice continued.
Nizatidine is a prescription drug used to treat ulcers in the stomach and intestine, as well as heartburn. It is considered an equipotent of ranitidine, the active ingredient in Zantac, but has a slightly different chemical makeup.
The U.S. Food & Drug Administration began investigating the presence of NDMA in Zantac last year, after the online pharmacy Valisure informed the agency it had detected the compound in every ranitidine sample it tested, and often at levels far above the recommended daily limit of 96 nanograms.
Valisure also asserted that NDMA was likely the result of the unstable ranitidine molecule, which appeared to produce the chemical when subjected to conditions that mimicked human digestion. Earlier this year, Emery Pharma revealed that its own tests indicated ranitidine produced NDMA when subjected to high temperatures typically encountered during shipment and storage.
The FDA has since confirmed that NDMA can increase in ranitidine over time and ordered drug makers to recall all generic and name-brand versions of Zantac from the market in the United States. The agency has also announced a number of recalls for nizatidine-containing heartburn drugs.