Novartis AG’s Sandoz unit, the maker of ranitidine, or Zantac, a popular heartburn medication announced today it would halt global distribution of the drug until U.S. and European agencies further investigate reports of an impurity found in some lots of the medication.
The FDA released a statement on Friday alerting patients and health care professionals of an impurity called N-nitrosodimethylamine (NDMA) found in some samples.
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.
The chemical is known as an environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
The FDA said it would evaluate whether the low levels of NDMA in ranitidine pose a risk to patients and will post that information when it is available.
The FDA has also been investigating the recall of generic blood-pressure pills that were also contaminated with NDMA late last year.
The agency doesn’t advise people to stop taking their medication, however, it said those taking OTC ranitidine could consider using other OTC medicines approved for their condition.
Consumers and health care professionals are encouraged to report any adverse reactions with ranitidine to the FDA’s MedWatch program:
You can 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
Ranitidine is an over-the-counter (OTC) and prescription drug. It’s an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach.
Over-the-counter ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach.
Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
Feature image courtesy: Novartis.
- FDA. (2019, Sept 13). Statement alerting patients and health care professionals of NDMA found in samples of ranitidine. Retrieved Sept. 18, 2019, from https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine