The Food and Drug Administration (FDA) is releasing a second method for manufacturers of ranitidine, the active ingredient in the brand-name and generic versions of the heartburn drug Zantac, to help detect and quantify a probable carcinogen known as N-Nitrosodimethylamine, or NDMA. The two methods approved by the FDA to test for NDMA include the LC-HRMS method and the LS-MS/MS method.
The announcement comes as two more manufacturers of ranitidine products announce recalls. The recall now includes the following:
- Dr. Reddy’s Laboratories Ltd – all prescription and over-the-counter (OTC) ranitidine tablets and capsules, which are labeled by retailers such as Walgreens, Walmart, CVS, Target, and Kroger.
- Sanofi – OTC ranitidine
- Apotex Corp. – OTC ranitidine tablets (75mg and 150mg) labeled by Walgreens, Walmart, and Rite-Aid.
- Sandoz Inc. – 14 lots of prescription ranitidine capsules.
On Sept. 9, 2019, the FDA issued a statement that some ranitidine medications were found to contain low levels of NDMA, a probable human carcinogen. NDMA is known as an environmental contaminant and is found in water and some foods, and likely contaminated the drugs during the manufacturing process.
The FDA has already been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure drugs called Angiotensin II Receptor Blockers, or ARBS, since last year, which has resulted in numerous recalls.
Ranitidine is a histamine-2 blocker sold both over-the-counter and by prescription to decease the amount of acid created by the stomach. OTC versions are used to prevent and relieve heartburn associated with acid ingestion and sour stomach. Prescription ranitidine is used for multiple indications including treatment and prevention of ulcers of the stomach and intestines and of gastroesophageal reflux disease.
The FDA recommends that patients taking prescription ranitidine who wish to discontinue use first talk to their health care professional about other treatment options. Those taking OTC versions of the drug may consider using other OTC heartburn medications.
Beasley Allen attorney Frank Woodson is actively investigating potential claims involving regular Zantac/ranitidine use that may have led to cancer of the stomach, colon, intestines, kidneys, bladder or pancreas. If you or a loved one may have been affected, please contact us.