Serious Injuries Linked to Zantac®

Why is Zantac® Being Recalled?

Based on results from laboratory testing, the U.S. Food and Drug Administration has learned that Zantac® and other ranitidine medicines contain a nitrosamine impurity called N–nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen – a substance that could cause cancer in humans. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

What is NDMA?

N–nitrosodimethylamine(NDMA) is classified as a probable human carcinogen which means that it is more likely than not to cause cancer in humans. NDMA has been studied in animal populations and found to increase the occurrence of cancer in the animals. The studies have raised the specter of an association between NDMA and liver toxicity which can lead to the development of liver cancer and other related conditions brought about by an NDMA–induced “insult” to the liver.

The degree and duration of human NDMA exposure that can lead to the development of cancer is not precisely known. Similarly, the extent and duration of the NDMA contamination of Zantac® and other ranitidine medicines are not precisely known. Efforts are underway to define the scope and degree of the NDMA contamination.

Diseases Associated with Exposure to NDMA

NDMA has been studied in animal populations and found to increase the occurrence of cancer in the animals. In light of these studies, the U.S. Environmental Protection Agency classifies NDMA as a probable human carcinogen. The studies have raised the specter of an association between NDMA and liver toxicity which can lead to the development of liver cancer and other related conditions brought about by an NDMA–induced “insult” to the liver. Some have suggested that NDMA may also be linked to other cancers such as:

  • Stomach Cancer
  • Bladder Cancer
  • Small Intestine Cancer
  • Colorectal Cancer
  • Esophageal Cancer
  • Liver Cancer
  • Prostate Cancer (Under the age of 65)
  • Pancreatic Cancer
  • Leukemia
  • Non–Hodgkin’s Lymphoma

Have Other Ranitidine Products Been Recalled?

Yes. The U.S. Food and Drug Administration has alerted health care professionals and patients to three voluntary recalls of ranitidine.

  • Perrigo Company plc has voluntarily recalled over–the–counter (OTC) ranitidine tablets (all pack sizes) due to the potential of N–Nitrosodimethylamine (NDMA) in the medicine.
  • Novitium Pharma LLC has voluntarily recalled all unexpired quantities and lots of ranitidine hydrochloride capsules due to the potential of NDMA in the medicine.
  • Lannett Company, Inc. has voluntarily recalled all unexpired lots of prescription ranitidine syrup (ranitidine oral solution, USP, 15mg/mL) due to the presence of NDMA found in the drug.

Should I Stop Taking Zantac® or Other Ranitidine Medicines?

As of 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.”

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CASE EVALUATION

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