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Zantac FDA Warning

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Patients and health care practitioners in the U.S. were notified on January 8, 2020, of two voluntary recalls of ranitidine – the active ingredient found in Zantac. According to the FDA Zantac warnings, the drug contains unacceptable levels of N-nitrosodimethylamine (NDMA) – a potential cancer-causing agent.

In April, 2020, the FDA formally requested the removal of all ranitidine products (Zantac) from the market.

Health officials at the agency said consumers may want to consider alternative heartburn medications that do not have carcinogenic risks. How did a popular acid-blocking drug, used by more than 15 million Americans, become such a public health concern?

Zantac FDA Warnings on NDMA

It’s a problem that FDA officials need to answer quickly. Zantac has been on the U.S. market since 1984, and it’s used worldwide. Since the FDA warning about ranitidine and NDMA cancer risks, Italy, France, Switzerland, Germany, and Canada have halted sales of the drug.

Rutter Mills is currently reviewing cases of patients who developed cancer after taking Zantac or its generic equivalent. Our firm has decades of experience holding pharmaceutical manufacturers liable for putting profits over consumer safety. Find out if you are eligible to seek legal compensation by speaking to a Zantac lawyer at Rutter Mills. The initial case review is free, and there is no obligation to proceed.

What is NDMA?

NDMA has been labeled an “extremely hazardous substance” by the U.S. Emergency Planning and Community Right-to-Know Act. It is an organic compound and known contaminant that occurs in both natural and industrial processes. Numerous animal studies have shown that NDMA increases cancer risk, but it is still uncertain if humans must be exposed to high doses over long periods of time to pose a real health danger. When animals breathed air, drank water, or ate food containing low quantities of NDMA for more than a few weeks, evidence of liver cancer, liver damage, and lung cancer was found.

The World Health Organization states that the mechanism by which NDMA causes cancer involves biotransformation by liver enzymes. Researchers also know that NDMA is ‘genotoxic.’ In other words, it damages DNA, and these mutations can cause cancerous cells to form. According to the Centers for Disease Control and Prevention, N-nitrosodimethylamine may be found in:

  • Disinfected drinking water
  • Rivers and lakes
  • Soil after chemical reactions involving alkylamines
  • Cured meats
  • Pesticides and detergents
  • Rubber and tire manufacturing plants

About the FDA Zantac update

According to the FDA warning, patients who are currently taking ranitidine are encouraged to talk to their health care professional about alternative treatment options. Those who are taking over-the-counter versions of Zantac should consider using other medications that are approved for the same purpose as ranitidine. These include Prilosec, Tagamet, Pepcid, Nexium, and Axid – all of which are approved to reduce acid and treat ulcers and heartburn.

It’s worth noting that plenty of ranitidine-containing drugs are still on the shelves, as the recall is purely voluntary. The FDA has advised companies to recall their medication only if testing indicates that NDMA levels are above the acceptable daily intake (96 ng). Health regulators continue to evaluate other medications, including proton pump inhibitors and H2 blockers, that could be safer alternatives to Zantac and its generic formulations.

Ranitidine risks spark recalls

The agency continues to test ranitidine products from various manufacturers to evaluate the potential effect on patients who have been exposed. FDA and ranitidine warnings have sparked a number of drug makers to pull their products off the shelves.

  • Last September, Novartis stopped distributing all forms of generic Zantac
  • Northwind Pharmaceuticals recalled all unexpired lots of ranitidine tablets on January 6, 2020
  • Appco Pharma, LLC voluntarily recalled all lots of ranitidine capsules based on tests that showed higher than normal levels of NDMA

Are you eligible to file a Zantac lawsuit?

At Rutter Mills, we advocate for consumers across the country who were injured by defective or dangerous products. If you took Zantac or its generic forms for an extended period of time and were diagnosed with cancer, you may qualify for legal compensation. Call or text our office to schedule a free Zantac lawsuit case evaluation.

We are proud to offer powerful, client-focused representation on a contingent-fee basis, so you owe nothing unless damages are recovered on your behalf.

Additional Resources:

  1. FDA, FDA Updates and Press Announcements on NDMA in Zantac (ranitidine) https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine
  2. BreastCancer.org, FDA Warns About Probable Carcinogen in Zantac https://www.breastcancer.org/research-news/fda-warns-about-probable-carcinogen-in-zantac
  3. FDA, Statement alerting patients and health care professionals of NDMA found in samples of ranitidine  https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine
  4. USA Today, Zantac is prescribed 15 million times a year. So how did it become a potential cancer risk https://www.usatoday.com/story/news/health/2019/11/07/how-did-zantac-become-potential-cancer-risk-fda-wants-find-out/2509043001/
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