Zantac recalled for carcinogen levels above FDA standardsNov. 27, 2019, 9:51 AM
The popular heartburn drug ranitidine, commonly known as Zantac, was voluntarily recalled due to the contamination of a human carcinogen that could potentially cause cancer. The recall includes oral tablets, capsules, and syrup.
Daily consumption of up to 0.096 micrograms of the detected carcinogen, N-Nitrosodimethylamin (NDMA) is approved by the FDA. After a comprehensive assessment completed by the FDA, it determined the levels of NDMA in ranitidine posed a low risk and are comparable to those found in grilled or smoked meats.
Although these results indicated relatively small levels of exposure, they still exceeded what the FDA deems acceptable for medications.
Along with the FDA, Vanderbilt University Medical Center is recommending that patients taking over the counter (OTC) ranitidine switch to other alternatives to treat their condition. The following OTC medications contained no presence of NDMA: Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole).
Patients who were prescribed ranitidine should speak with their health care provider about alternative treatment options.
“Although the reports resulted in low levels of NDMA, it’s important to maintain an appropriate standard for medications that are taken daily to ensure they’re not causing unnecessary long-term side effects,” said Tennessee Poison Center Executive Director Donna Seger, MD, also a professor of Clinical Medicine and Emergency Medicine at Vanderbilt University Medical Center.
The FDA is asking that manufacturers execute their own testing and recall their medications as well if their NDMA levels are above the recommended daily volume.
Continued updates can be found on the FDA website at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine.