In response to questions about Zantac in the news, we have prepared this article so you can be better informed. Let us know if you have additional questions.
As many of you may have heard or read about, recently the Federal Drug Administration (FDA) learned that some ranitidine products, including some products with the brand name Zantac, may contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.
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.
At this time, the FDA is not recommending discontinuation of the use of ranitidine. The amount of NDMA that has been found in some ranitidine containing products is about the same as you could find in common every day foods and drinks. We at Kressly Pediatrics are comfortable with the continued use of ranitidine in the treatment of our patients with gastro-esophageal reflux (GER).
Here is the link
if you would like to read the entire statement from the FDA.