It has only been a matter of months since “N-nitrosodiethylamine” became a household name. The chemical, otherwise known as NDMA or NDEA is a probable human carcinogen that had been showing up in places it doesn’t belong- namely, common high blood pressure medications such as Losartan. (1)
Now, the FDA reports that trace amounts of NDMA have been detected in a popular heartburn medication.
NDMA Found in Heartburn Medication
On Friday, September 13th, the FDA released a statement to healthcare providers and to the public that lab test indicated the presence of NDMA in ranitidine. (2)
“The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels,” writes the Director of Center for Drug Evaluation and Research, Dr. Janet Woodcock. (2)
What is NDMA?
NDMA is classified as a “probable human carcinogen” after the results of a number of animal studies. Low levels of the chemical can be found in foods and drinking water.
NDMA was previously used in the production of rocket fuel, antioxidants, and plastics according to the U.S. Environmental Protection Agency. (3)
At room temperature, NDMA is a yellow liquid with a faint or no odor. It evaporates and is broken down quickly in sunlight, however it can spread very quickly in the soil. There is ongoing concern about NDMA contamination in groundwater. Various states have introduced regulations to measure and control NDMA in drinking water, however no federal-level regulations are currently in place. (3)
Is Zantac Being Recalled?
Since last year, the FDA has been actively testing and tracking nitrosamine contaminants in blood pressure medications. As we know, those tests resulted in a number of recalls to protect the public from harmful impurities. (2)
In the case of ranitidine medications, however, the FDA does not currently see a need for a product recall.
“The FDA is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients. FDA will post that information when it is available,” says Dr. Woodcock. (2)
In the meantime, FDA officials are continuing to work with industry partners and regulators to find the source of the NDMA contamination.
The makers of Zantac issued a statement, saying “Sanofi takes patient safety seriously, and we are committed to working with the FDA. Zantac OTC (over the counter) has been around for over a decade and meets all the specified safety requirements for use in the OTC market.”
Legal Backlash Against Makers of Zantac
In the days following the FDA’s public statement, a class action lawsuit has been filed against Sanofi and Boehringer Ingelheim in the U.S. District Court for the Northern District of California. (3)
The lawsuit alleges that Zantac makers knowingly deceived consumers about the safety of their product. Named plaintiffs Christina Garza, Pankaj Khetarpal, Corina Lingerfelt, and Justin Rowe allege that Sanofi’s sales of Zantac were only the result of concealing NDMA traces. (3)
“Millions of people in the U.S. suffer from heartburn, and for years, Zantac has been sold to the masses as a safe and easy-to-find remedy for that common ailment,” said Steve Berman, the Hagens Berman attorney leading the class action suit. “We’re certain that if those millions of consumers knew that the Zantac they take contains known carcinogens, they would be rightfully outraged.” (4)
Should You Stop Taking Your Medication?
Ranitidine is available both over the counter and as a prescription. It’s often prescribed to treat heartburn and stomach ulcers.
If you currently take a form of ranitidine, you can discuss the risks and benefits to your health with your doctor or pharmacist (even if you’re taking over the counter ranitidine).
It is not recommended that you stop your medication without consulting your healthcare provider. (2)
What to Do If You Have an Adverse Reaction
Consumers and health care professionals should report any adverse reactions with ranitidine to the FDA’s MedWatch program to help the agency better understand the scope of the problem:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm
- Or download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178
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