Based on results from Lab testing, the US FDA has learned that Zantac® and other ranitidine based medications contain a nitrosamine impurity named N–nitrosodimethylamine (NDMA) at lower levels. NDMA is classified as a probable human carcinogen – a substance may cause cancer in humans. NDMA is a known environmental contaminant and observed in water supplies and food sources, including meat, dairy products, and vegetables.
What is NDMA?
N–nitrosodimethylamine (NDMA) is classified as a probable human carcinogen which means that it’s more likely than not to cause cancer in humans.
zantac has been studied in animal populations and found to increase the creation of cancer in the animals. The research has enhanced the opportunity of an association between NDMA and liver toxicity that might lead to the development of liver cancer and various connected conditions created from an NDMA–induced reaction to the liver.
The degree and duration of human NDMA exposure which can lead to the development of cancer is not precisely known. Similarly, the extent and length of the NDMA contamination of Zantac® and other ranitidine medicines are not exactly understood.
Issues Connected with Exposure to NDMA
NDMA has been researched in animal groups and determined to increase the creation of cancer in the animals. Based on these studies, the U.S. Environmental Protection Agency classifies NDMA as a probable human carcinogen. The studies have increased the probability of a connection between NDMA and liver toxicity that can lead to the creation of liver cancer and various related issues created by an NDMA injury to the liver. Some have claimed that NDMA may also be associated to other cancers such as:
Small Intestine Cancer, Liver Cancer, Pancreatic Cancer, Leukemia.
Has Other Ranitidine Products Been Recalled?
Yes. The U.S. Food and Drug Administration has contacted health care professionals and patients to three existing voluntary recalls of ranitidine.
Perrigo Company plc has voluntarily recalled over–the–counter (OTC) ranitidine tablets due to the potential of N–Nitrosodimethylamine (NDMA) in the medicine.
Novitium Pharma LLC has voluntarily recalled all unexpired amounts and lots of ranitidine hydrochloride capsules due to the possibility of NDMA in the medication.
Lannett Company, Inc. has voluntarily recalled all unexpired lots of prescription ranitidine syrup due to the presence of NDMA found in the drug.
Should I Cease Taking Zantac® or Other Ranitidine Medicines?
On October 28, 2019, the FDA advised patients and consumers taking Zantac® and other ranitidine medications as follows:
“Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options.
zantac taking OTC ranitidine, which is used to prevent and relieve heartburn associated with acid indigestion and sour stomach, may consider using other OTC products approved for their condition. FDA’s testing of samples of alternatives such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) show no NDMA in these medicines.”
Consultation
Meneo Law Group is a leading consumer law firm for the recovery of damages because of to NDMA exposure. Feel free to contact us at any time to discuss your injury and potential for recovery.