NEW YORK—The Food and Drug Administration alerted health care professionals that the heartburn medication Zantac and its generic form, ranitidine, contains a “probable human carcinogen.” The drug contains an impurity called NDMA which appeared in blood pressure and heart failure medicines that were previously recalled.
As of Oct. 3, over three dozen countries have recalled or banned the drug. Canada was the first to issue an outright ban and Taiwan is taking the strongest action, fining manufacturers that don’t comply with the recall order.
In the United States, following the FDA warning, major pharmacies including CVS, Walgreens, Walmart, and Rite Aid have suspended the sale of the drug as a precaution.
The pharmacy Valisure detected N-nitrosodimethylamine (NDMA) in Zantac and ranitidine during routine testing in June and notified the FDA. On Sept. 13, Valisure pressured the FDA to issue a recall of the drug.
Valisure CEO David Light said the impurity, NDMA, has been a known carcinogen for decades. “It’s actually used as a control to induce cancer in rats in clinical studies. It’s used in pesticides, rocket fuel. You absolutely do not want it in your medicine,” he said in a video statement issued by the company.
Valisure found over 3 million nanograms (pdf) of NDMA per tablet, which exceeds the daily intake limit of 96 nanograms established by the FDA. The test showed that ranitidine can react with itself at 130° Celsius to form NDMA probably because of an “inherent instability,” says Valisure.
In its petition to the FDA, Valisure said this test presents a compelling case that ranitidine can cause cancer because “NDMA occurs in the conditions representative of those in the human body.”
The FDA responded in a statement on Oct. 3, saying, “That method is not suitable for testing ranitidine because heating the sample generates NDMA.” The FDA recommends testing the drug with an LC-HRMS procedure that does not use elevated temperatures. This procedure “has shown the presence of much lower levels of NDMA in ranitidine medicines than reported by the third-party laboratory.”
A family practice physician in New York, Albert Levy, said he hasn’t seen a stomach cancer case he knows was caused by the long-term use of ranitidine. “I don’t think the public should be panicking,” Levy said. “It is more of a precaution than anything else.”
Levy, however, recommends that patients on ranitidine should stay away from the drug until we know more. He said that Pepcid or its generic form famotidine is a good alternative to Zantac. He suggests that patients should contact their doctor to find a good alternative.
Reuters contributed to this report.
From NTD News