USA -The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, 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.
About a month ago the FDA was 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.
The company that recently tested the heartburn drug recommended that it be recalled, and now it is being taken off the market.
At Blair Gastroenterological Associates, Dr. Ralph McKibbin says, Things could be or should be recalled, until we can determine the safety, and certainly, why can’t we just eliminate it, as it’s not in the other products in the similar category.”
Dr. McKibbin says that’s good advice, but , he added, in the long run, “Every medication has potential side effects, so you take it for the shortest time and try to fix the underlying condition and eliminate the need for medication.”
