Potential Cancer Risk: FDA Urges Withdrawal of Zantac and Ranitidine Medication

Zantac, also known as ranitidine, is a widely used histamine-2 blocker that reduces stomach acid production. Primarily prescribed for heartburn relief and the treatment/prevention of ulcers and gastroesophageal reflux disease; however, recent discoveries have raised concerns about the safety of these medications.

Recent findings have revealed the presence of a contaminant called N-Nitrosodimethylamine (NDMA) in Zantac and other ranitidine products. NDMA is classified as a probable human carcinogen, indicating its potential to cause cancer in humans. While low levels of NDMA are commonly consumed through diet, prolonged exposure to elevated levels may pose an increased risk of cancer.

Notably, studies have shown that NDMA levels in some ranitidine products can rise over time at room temperature, with higher temperatures exacerbating this potential hazard.

In response to these findings, the FDA has swiftly acted by conducting rigorous laboratory tests and issuing letters to all ranitidine manufacturers, urging them to withdraw their products from the market. This proactive approach was driven by the FDA’s commitment to prioritizing patient safety and minimizing potential harm associated with the use of affected ranitidine medications. Following the FDA’s market withdrawal of all prescription and over-the-counter ranitidine medications, Zantac underwent a rebranding as Zantac 360, which no longer contains ranitidine as its active ingredient. Instead, Zantac 360 now utilizes famotidine as its primary component.

Given the significant number of reported cases and the presence of NDMA in Zantac and ranitidine, regulatory measures have been implemented by the FDA. Patient safety remains paramount, and the FDA advises individuals currently using Zantac or ranitidine to consult their healthcare providers for alternative treatment options.

These precautionary measures underscore the FDA’s dedication to ensuring the well-being of patients and highlight the importance of ongoing research and vigilance in the field of pharmaceutical safety.

Author: Manny Gonzalez-Brito, DO, LW CMO (LifeWallet Chief Medical Officer).

Disclaimer:

This information is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medication, medical condition or treatment.

Sources:

1. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market
2. https://www.fda.gov/safety/medical-product-safety-information/all-ranitidine-products-zantac-press-release-fda-requests-removal