In a statement from the U.S. Food and Drug Administration (FDA), on Sept. 14, it was revealed that low levels of a carcinogenic substance were discovered in heartburn medication Zantac and its generic variants.
Increased risk of several different kinds of cancers has been linked to the chemical NDMA, or N-Nitrosodimethylamine.
In the statement, the agency says that it “has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain” the impurity.
Generic versions of the Zantac that contain ranitidine are said to have the chemical.
“When the agency identifies a problem, it takes appropriate action quickly to protect patients. The FDA is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients. FDA will post that information when it is available,” the statement read.
The origins of NDMA contamination are unclear, but the chemical triggered the recall of some heart and blood pressure medications over the past year or so.
Zantac has yet to be recalled over the finding.
“Patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health,” said the agency.
“Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods,” the statement continued.
Prilosec, Nexium, Prevacid, and other heartburn drugs have different ingredients and are excluded from the FDA alert.
According to The U.S. Centers for Disease Control and Prevention (pdf), NDMA has been found in fish, tobacco smoke, cosmetic products, cured meats, and a number of other items.
An Update From the FDA
Some months ago, the FDA released a list of nitrosamine-free blood pressure medications that are safe to use.
On April 5, a list of approximately 40 blood pressure and heart medications that don’t contain the cancer-linked nitrosamine, was posted by the agency.
The issue initially surfaced in July of 2018, when the FDA claimed they recalled several medications with valsartan after impurities were discovered.
Those recalled medications were said to be manufactured by a drugmaker located in China.
According to an April 4 press release, the FDA has, since then, “been working to thoroughly understand how this issue arose, how we could address and mitigate exposure to this unnecessary risk to patients, and what we could do to prevent these types of impurities from reoccurring in future medications.”
In the statement, the health agency added that the presence of nitrosamines in drug products is “not acceptable.”
“We’re also continuing to work with manufacturers to swiftly remove medications from the market if they contain a nitrosamine impurity at levels higher than the interim acceptable intake limits,” the agency also said.
“Removing the affected medications from the market has led to shortages, and since then, we’ve been working to mitigate and prevent shortages as often as possible.”
N-dimethylnitrosamine (NDMA), N-diethylnitrosamine (NDEA), 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), are among common nitrosamines.
The list of “safe” medications can be found on the FDA’s website. Drugs marked “not present,” mean the FDA “has completed the comprehensive assessment noted above.”
