The move comes after an ongoing investigation revealed that the level of the contaminant and probable carcinogen found in some ranitidine products, N-nitrosodimethylamine (NDMA), was found to increase to unsafe levels over time. Zantac will no longer be available for new or existing prescriptions or for sale as an over-the-counter medication at pharmacies or other retailers, according to the statement. Zantac is an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach. Commonly used to help with heartburn and the prevention of ulcers, the drug first came on the market in 1981 and by 1988 was the second drug in history to reach $1 billion in annual sales, according to a New York Times report at the time. In September 2019 the FDA issued an alert to consumers and doctors that NDMA had been found in some Zantac products and pledged to “evaluate whether the low levels of NDMA in ranitidine pose a risk to patients.” A month later, Sanofi, the company that now manufactures and distributes Zantac, conducted a voluntary recall of the drug because of inconsistencies in preliminary test results, according to a company statement sent to Everyday Health. At that time all retailers and consumers were instructed to return or destroy the product, said Sanofi. “Now it’s mandatory to remove Zantac from the shelves, though I think a lot of the businesses had already done it,” says Emeran Mayer, MD, a gastroenterologist and a professor of medicine at David Geffen School of Medicine at the University of California in Los Angeles. “I think this is a very careful position that the FDA has taken, and it shouldn’t have a lot of consequences for patients,” says Dr. Mayer, adding that many consumers have already switched to alternative products.
Contaminant Could Rise Above Safe Levels When Stored
Further investigation revealed that the amount of NDMA can increase over time when the drug is stored at higher than room temperatures, and this could result in higher than accepted safe levels of the impurity, said the FDA. There were many samples of Zantac that didn’t contain high levels of NDMA, said Janet Woodcock, MD, the director of the FDA’s Center for Drug Evaluation and Research, in the statement released on Wednesday. “However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” she said. NDMA, part of a class of compounds known as nitrosamines, has also been found in lab analysis of nizatidine products that were recalled by the FDA. The impurity is also present in water and some foods, including processed meats, dairy products, and vegetables, according to the FDA. The accepted safe level is .096 micrograms or .32 parts per million of NDMA. RELATED: Are There Ways to Reduce Your Risk of Cancer?
The Risk Posed by Low Levels of NDMA Is Low
The FDA does not expect nitrosamines to cause harm when ingested at low levels, according to Sarah Peddicord, a spokesperson for the FDA. “Nitrosamine impurities may increase the risk of cancer if people are exposed to them at above acceptable levels and over long periods of time, but a person taking a drug that contains nitrosamines at, or below, the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer,” she wrote in an email to Everyday Health. “The FDA made this decision because of concerns about the long-term intake and the dose a person might accumulate over a period of time, which can increase the risk of cancer, though that risk is really quite low,” says Dr. Mayer. “If this were a drug without any substitutes or alternatives, I’m not sure they would have taken this step,” he adds. The FDA request to withdraw is the strongest action the agency can take for this class of medication. “Our recall authority for drugs is over controlled substances,” said Peddicord. “We generally request removal of drug products, and we expect that industry will be fully compliant, as many ranitidine products have already been removed from the shelves via voluntary recalls by companies.” “We take this issue seriously and continue to work closely with the FDA to evaluate any potential safety risks associated with Zantac,” said Sanofi.
What to Do if You Take Zantac
For those people who take nonprescription Zantac, there are many over-the-counter (OTC) alternatives, says Mayer. “There really shouldn’t be any therapeutic consequences for a consumer to switch to Tagamet or a PPI (proton pump inhibitor),” he says. If you are taking prescription Zantac or any medication that has been found to potentially contain NDMA, the FDA recommends the following steps:
Don’t stop taking your prescription medication until you talk to your healthcare provider.Questions about your medication or the recall can be answered by your pharmacist or by calling the FDA at 855-543-3784.
