According to the American College of Gastroenterology, acid reflux, also known as heartburn, affects over 60 million Americans every month. Many Americans who have chronic acid reflux are prescribed medication for treatment. The most common treatment for infrequent heartburn is the over the counter medication ranitidine, most commonly known by the brand names such as Zantac. The medication is currently under an evaluation to measure the levels of N-nitrosodeimethylamine (NDMA) and its possible risk to patients.
The Food and Drug Administration (FDA) issued a statement in September alerting the public and health care professionals about the discovery of NDMA, a substance that is classified as a probable human carcinogen that could cause cancer, found in samples of ranitidine in recent laboratory tests. The FDA has yet to determine if the chemical found in ranitidine has high enough levels to cause a health risk. Consumers should also be aware that the FDA is not advising individuals to stop taking ranitidine but informing them that they may want to speak with their healthcare professional about other treatment options.
The NDMA Chemical
The probable carcinogen that was found in the affected heartburn medication is an environmental contaminant called NDMA. Exposure in high amounts has been linked to gastric and colorectal cancer. The chemical is toxic to the liver and may cause liver damage in even small amounts. NDMA is a byproduct of many manufacturing activities such as pesticide manufacturing, rubber and tire manufacturing, and leathermaking.
The FDA has had its eye on medications containing unsafe levels of NDMA since 2018. In July of 2019, the FDA issued recalls for several blood pressure medications including losartan, irbesartan, and valsartan.
Discovery of NDMA in Ranitidine Leads to Voluntary Recall
Although no official recall for ranitidine medications, such as Zantac, has been issued, manufacturers and stores have issued voluntary recalls and pulled products off shelves. Sandoz Inc., the manufacturer of ranitidine hydrochloride capsules 150mg and 300mg, has issued recall instructions to their distributors but has not told customers to stop the use of the medication. Apotex Corp., another ranitidine manufacturer has also issued a recall for their ranitidine medications.
In addition, CVS, Walmart, and Walgreens have stopped selling Zantac and similar medication. Pepcid and Tagamet, which are not known be contaminated with the probable carcinogen, are expected to continue to be available.
What to Do Next
If you use heartburn medications like Zantac, speak to your doctor about the risk and potential alternative treatment. If you or a loved one suspect you have been seriously injured due to a drug, you may be entitled to pursue a product liability claim. Contact Panter, Panter & Sampedro, P.A. to schedule a free consultation with one of our product liability attorneys by calling (305) 662-6178.
References:
Center for Drug Evaluation and Research. (2019, September 23). Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to An Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA), in the Product. Retrieved October 9, 2019, from https://fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg-due-elevated.
Criss, D. (2019, October 2). Walmart, CVS, Walgreens pull Zantac and similar heartburn drugs because of cancer worries. Retrieved October 7, 2019, from https://cnn.com/2019/09/30/health/cvs-zantac-pulled-cancer-trnd/index.html.
MacGill, M. (2017, November 13). Acid reflux: Causes, treatment, and symptoms. Retrieved October 9, 2019, from https://medicalnewstoday.com/articles/146619.php.
Ries, J. (2019, September 30). CVS and Walgreens Stop Selling Zantac After Cancer-Causing Chemical Detected. Retrieved October 8, 2019, from https://healthline.com/health-news/fda-warns-zantac-may-have-carcinogen.
