The Food and Drug Administration (FDA) has announced that low levels of a potentially dangerous contaminant have been found in Zantac heartburn medication, both the prescription and over-the-counter version of the popular drug taken to treat stomach acid and ulcers.
FDA officials report that while the amount of NDMA found in the drug “barely exceeds levels found in common foods,” the contaminant is dangerous and has been linked to an increased risk of colorectal cancer and uterine cancer. Ranitidine is the generic name for Zantac; there is no recall in place at the time of this writing. You may remember that NDMA was the same contaminant found in prescription hypertension (high blood pressure) medicine; numerous high blood pressure medications were recalled in 2018 and even as early as 2014.
What is NDMA?
NDMA is N-nitrosodimethylamine, a chemical classified as a “probable human carcinogen” associated with liver cancer, colorectal cancer, colon cancer, stomach, cancer, and pancreatic cancer. Once used to make rocket fuel and lubricants, NDMA no longer is used commercially in the United States.
The two main concerns of NDMA contamination are as follows: 1) the length of exposure and severity of exposure to NDMA that’s required to cause cancer is not yet known, and 2) the amount of medications contaminated by NDMA is still not certain. NDMA exposure to the high blood medications including valsartan happened over a four-year period, and the exposed valsartan made its way into a number of medications.
Unsafe, Unsanitary Conditions?
The FDA is tasked with ensuring U.S. medications are made in safe, sanitary conditions, but FDA regulators have struggled for years with how to adequately watch over pharmaceutical production as it has spread out of the United States to all corners of the globe. Most pharmaceutical companies have moved their manufacturing plants overseas in an effort to save money on labor and materials. As a matter of fact, approximately 80% of ingredients used in United States’ drugs are manufactured abroad including China and India, mainly.
People Urged to Stop Zantac
According to medpagetoday.com, “One manufacturer of generic ranitidine (Zantac), Novartis’s Sandoz unit, has reportedly decided to halt distribution of the antacid drug until a contamination issue is resolved.”
Although no recall has been ordered yet, the FDA has said that people using OTC ranitidine for heartburn and other stomach-related issues “could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.” If you’re currently taking Zantac either OTC or prescription formula, please consult your physician about your concerns and get medical advice on which similar drug would be best for you.
During the time of the blood pressure medication recall, one company in China, Zhejiang Huahai Pharmaceuticals, was discovered to have produced contaminated pills, so the FDA placed this company on an import alert in September 2018, which means that all active pharmaceutical products made by this company are not allowed to enter the United States.