Sept.13, 2019 – A certain medication used to treat millions of people each year with gastrointestinal problems was recalled due to the presence of a human carcinogenic.
Zantac and NMDA
The generic ranitidine is a drug used in many antacid and antihistamine products. It can be found under the brand name Zantac, manufactured by Sanofi, and other generic versions manufactured by many other companies.
It’s considered an over-the-counter (OTC) prescription drug. It’s also known as an H2 (histamine-2) blocker, which helps decrease stomach acid. Additionally, it can be used to treat ulcers of the stomach and intestines, as well as gastroesophageal reflux disease.
Zantac helps prevent a variety of stomach and gastrointestinal troubles in millions of people worldwide. But drug officials in both Europe and the United States are concerned about the presence of N-Nitrosodimethylamine, or NDMA, recently detected by an online pharmacy.
According to the International Agency for Research on Cancer “NDMA has been classified [by IARC] as probably carcinogenic to humans.” It can actually be found as a byproduct of cooked or cured meats, such as bacon.
NMDA was detected by New Haven, Connecticut-based online pharmacy, Valisure, which tests all medications it dispenses to buyers. Valisure immediately alerted the Food and Drug Administration to the high levels of NDMA it detected in both Zantac brand and generic versions.
An email to Bloomberg from Ashleigh Koss, a spokeswoman for Sanofi, said the company “takes patient safety seriously, and we are committed to working with the FDA.”
Zantac is made in Mexico but Sanofi sources its ingredients from Spain, she said. The Zantac and generic versions can be found at major pharmacies such as Walgreens Boots Alliance Inc., CVS Health Corp. and Walmart Inc.
NDMA Found in Other Medications
The FDA has been concerned about the growing presence of NMDA in other medications as well. “The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year,” the agency said in a press announcement. “In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.”
Valisure filed a petition with the FDA to recall Zantac and generic medications that contain NMDA. However, the FDA wrote back and said the levels were low. Yet, Valisure called them “excessive.”
Valisure detected NDMA levels as high as 3,000 micrograms in Zantac and generic versions. Compared to 17 micrograms in blood-pressure medication that made headlines last year, many people are concerned about the carcinogen levels.
Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said the agency isn’t ready to begin a recall until more samples have been collected.
“We don’t think this poses an immediate hazard to human health so we’ll have an ongoing process to determine whether recalls are needed,” she said.
The FDA doesn’t recommend people stop taking Zantac or generics, but other medications are available if people are concerned.
This story will be updated as it develops.
Do you have a Zantac lawsuit?
If you have been diagnosed with cancer after taking Zantac, we would like to speak with you. High levels of cancerous NMDA were found in the medication in 2019. If you believe your cancer stems from taking Zantac or a generic version, contact a Zantac lawyer today. We offer a Free Lawsuit Evaluation and would be honored to speak to you.