The FDA has recalled popular over-the-counter and prescription heartburn ranitidine drugs (or otherwise known as Zantac) due to unsafe levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen. This recall came as a result of an ongoing investigation of NDMA discovered in ranitidine medications.
The investigation into NDMA
In the summer of 2019, it became known that low levels of this substance had been found in ranitidine medicine. Low-levels of this NDMA are often found in food products, but these low levels are not expected to increase the risk of cancer. High levels of exposure to NDMA do increase the risk. Upon discovering the possibility of NDMA in ranitidine, the FDA investigated whether these drugs form NDMA in the human body. The FDA warned the public about the possibility of NDMA in the medication back in September 2019 but did not have enough evidence to issue a mandatory recall. However, the FDA did request a voluntary recall and asked manufacturers to conduct their own laboratory testing and send samples to the FDA.
In April of this year, FDA testing confirmed NDMA levels increase in ranitidine drugs over time, even with normal storage conditions, especially the further the product gets from its date of manufacturing. Also, the NDMA levels increase when the drugs are stored at higher temperatures.
Many companies did voluntary recalls on the ranitidine products prior to this mandatory recall by the FDA. Sanofi recalled its over-the-counter Zantac in October of last year. Appco Pharma LLC and Northwind Pharmaceuticals did so in January. Many drug stores took action as well, including CVS and Walgreens, who stopped selling Zantac and other ranitidine drugs as of last year.
What to do if you are taking a rantinide drug (Zantac)?
Consumers are being advised to stop taking any current over-the-counter Zantac they currently have and switch to other approved over-the-counter heartburn medicines. For those on prescription Zantac, speak with their healthcare professional immediately about alternative options. When disposing of the medication, the FDA advises consumers and patients to follow the medication disposal information on the packaging included with the medication.
Several drugs that serve the same purpose as ranitidine drugs do not have the same risks from NDMA. At this point, only if a company can prove to the FDA that their ranitidine product is stable and that the NDMA levels do not increase to unsafe levels, will any be back on the market and available to patients and consumers. It’s always essential to stay up to date about the medication you are taking, so check in with the Drug Law Journal for ongoing news and up-to-date information.
Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.