Based on results of laboratory evaluation, the Food and Drug Administration has determined that Zantac® and various ranitidine based medications have a nitrosamine impurity called N–nitrosodimethylamine (NDMA) at lower amounts. NDMA is classified as a likely human carcinogen – a substance that could cause cancer in humans. NDMA is a known environmental contaminant and noticed in water supplies and foods, including meat, dairy products, and vegetables.
What is NDMA?
N–nitrosodimethylamine (NDMA) is considered as a likely human carcinogen that means that it is more probable than not to cause cancer in humans. zantac recall has been studied in animal populations and found to increase the occurrence of cancer in the animals. The studies have enhanced the chance of an connection between NDMA and liver toxicity which might lead to the development of liver cancer and various related conditions brought about by an NDMA–induced treatment of the liver.
The amount and duration of human NDMA exposure that can begin the development of cancer is not precisely known. Also, the extent and length of the NDMA contamination of Zantac® and other ranitidine medicines are not precisely understood.
Diseases Associated with Exposure to NDMA
NDMA has been studied in animal groups and determined to increase the happening of cancer in the animals. Based on these studies, the Environmental Protection Agency classifies NDMA as a probable human carcinogen. The studies have raised the likeliness of an association between NDMA and liver toxicity which may lead to the development of liver cancer and other related conditions due to an NDMA injury to the liver. Others have claimed that NDMA may also be linked to other cancers such as:
Small Intestine Cancer, Esophageal Cancer, Pancreatic Cancer, Non–Hodgkin’s Lymphoma.
Have 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 medication.
Novitium Pharma LLC has voluntarily recalled all unexpired amounts and lots of ranitidine hydrochloride capsules because of the potential of NDMA in the medication.
Lannett Company, Inc. has voluntarily recalled all unexpired lots of prescription ranitidine syrup because of the presence of NDMA found in the drug.
Should I Stop Taking Zantac® or Other Ranitidine Medicines?
On October 28, 2019, the FDA advised patients and consumers taking Zantac® and other ranitidine medicines as follows:
“Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Consumers 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 due to NDMA exposure. Feel free to contact us at any time to explore your injury and potential for recovery.
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