What Does the FDA Say About Zantac?

Beginning in September 2019, the U.S. Food and Drug Administration (FDA) had a lot to say about Zantac. When it comes to Zantac, the FDA says it actively managed concerns over the levels of N-nitrosodimethylamine (NDMA) in generic ranitidine heartburn and reflux medications.

The FDA sets the daily allowable intake limit for this medication at 96 nanograms per day. When they tested ranitidine samples, many exceeded this level.

Hence the FDA says this about Zantac: The agency advised the affected companies to voluntarily recall their products. In addition, stores pulled their products from the shelf out of an abundance of caution because they might be contaminated. The agency also advised drug companies to conduct their own laboratory testing to ensure safe levels.

The FDA Says a Lot About Zantac and NDMA

The FDA’s concern over NDMA is that it is a “probable human carcinogen,” meaning it can likely cause cancer in humans based on laboratory tests. It is a known carcinogen in animals, and may be used to cause tumor growth for research on mice, rats, hamsters, and other rodents.

As of March 2020, the FDA believes that Zantac and similar drugs only contain low levels of NDMA. It is important that drug manufacturers, distributors, and the general public understand the risk surrounding Zantac and NDMA. The FDA wants to give consumers adequate warnings about the presence of a carcinogen.

Zantac was recalled because of NDMA contamination. According to the FDA, they have also recommended similar recall actions for companies that produce certain blood pressure and heart failure drugs. Known as angiotensin II receptor blockers or ARBs, the FDA began investigating NDMA levels in these drugs in 2018, and there have been several recalls due to their high levels within this substance.

The FDA is Not Telling People to Stop Using Ranitidine

In September 2019, when the FDA made the initial announcement about NDMA contamination, the agency did not call for people who take Zantac or other ranitidine-based drugs to stop using them. They believe the contamination to be only slightly above allowable levels and not immediately dangerous. The FDA says this about Zantac: “Those who are prescribed prescription Zantac (ranitidine) and want to change medications should discuss it with their doctor to determine another treatment option and get a new prescription. Those who take a ranitidine product sold over the counter may consider changing to a different medication to help manage heartburn or acid reflux.”

The FDA stressed that there are several medications on the market that are effective for reducing heartburn, stopping acid reflux, preventing damage to the esophagus from acid, and other similar uses as Zantac.

Claimants Pursuing Cases Against Zantac Believe Reality is Much Worse Than FDA Claims

While the FDA stands by its testing and findings that the levels of contamination in the affected ranitidine products are only slightly above allowable levels, those filing lawsuits against the drug manufacturers see things differently. According to legal documents filed in the ranitidine cancer and Zantac multidistrict litigation (MDL), there have been almost 200 studies and articles that connect NDMA to cancer in humans, including tumors originating in a wide range of areas, such as:

  • Stomach
  • Intestines
  • Liver
  • Pancreas
  • Esophagus
  • Kidney
  • Bladder

While the claimants believe possible NDMA contamination is a problem and could potentially cause cancer and other significant medical concerns, they allege that there is a bigger problem with ranitidine. The documents filed as a part of the MDL claim that Zantac, in combination with certain foods, metabolizes into much higher levels of NMDA.

This could be as high as “tens of thousands of times” higher than the daily threshold the FDA considers safe level in medications. To make matters worse, the foods that cause this increase also might trigger heartburn, so a person is likely to use this medication in conjunction with eating high-nitrate foods.

Talk to a Zantac Cancer Lawyer For Free Today

If you took Zantac and believe it may have played a role in your cancer or another significant medical condition such as liver failure, call Zanes Law for a free case review today. We can evaluate the merits of your case, explain your legal options, and sign you up for representation during the same call.

Our initial case consultations are always free, and there is no obligation to work with our team on your case. If you decide to let us handle your lawsuit, we will agree to do so on a contingency basis. This means you will not pay any upfront costs.

Call (866) 499-8989 now to discuss your case with a Zantac cancer lawyer for free.

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