The FDA’s Director of Drug Evaluation and Research Janet Woodcock, MD, released a statement today warning of low-level traces of N-nitrosodimethylamine (NDMA) found in some ranitidine medicines including brand-name Zantac.
Ranitidine is an OTC and prescription histamine-2 blocker that decreases the amount of acid created by the stomach. It is approved by the FDA to prevent and relieve heartburn, along with other multiple indications.
According to the FDA, NDMA is a known human carcinogen and enviornmental contaminent found in water and foods including meats, dairy products, and vegetables. Currently, the FDA says the levels found in ranitidine products are no greater than what would be found in common foods.
The FDA has been investigating NDMA traces and other impurities in blood pressure and heart failure (Angiotensin II receptor blocker) medicines since last year, according to today’s statement.
At this time, the FDA is not requiring patients to suspend their medication regimens, but does suggest that patients looking to stop taking their ranitidine medications should consult their healthcare providers.
To report adverse reactions while taking ranitidine,
- Complete and submit the report online at www.fda.gov/medwatch/report.htm
- Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178