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‘Stop Taking Zantac Immediately,’ Says the FDA

Zantac has been facing federal scrutiny and legal trouble since September 9, 2019, when online pharmacy, Valisure, sent a citizen’s petition to the U.S. Food and Drug Administration (FDA).

According to the petition, Zantac and other medications with the active ingredient ranitidine contained unacceptably high levels of N-Nitrosodimethylamine (NDMA), which is a probable human carcinogen (or a substance that could cause cancer).

Unsafe for Use

On April 1, 2020, the FDA asked that Zantac be removed from the market entirely. While manufacturer, Sanofi, originally recalled the popular drug in October of 2019, the company cited “inconsistencies in preliminary test results.” With its decision on April 1, however, the FDA has largely dismissed these inconsistencies and deemed ranitidine products like Zantac unsafe for use.

Per the April 1 release, all manufacturers should withdraw their drugs from the market immediately and doctors should no longer prescribe ranitidine in the U.S. The FDA also urged consumers to stop taking Zantac immediately, safely dispose of any remaining pills or liquids, and not buy more.

Other Options

So far, alternate heartburn medications like Pepcid (famotidine), Nexium (esomeprazole), and Prilosec (omeprazole) have not tested positive for NDMA.

As such, the best way to prevent both excessive NDMA exposure and heartburn is to switch to one of these alternate medications.

The FDA puts it simply:

There are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA.”

What Are the Risks From NDMA?

NDMA is an environmental contaminant that we are exposed to in small doses nearly every day. Found in our water, dairy products, vegetables, grilled meats, and other foods, small doses of NDMA do not appear to cause adverse effects or increase the risk of cancer.

Nevertheless, if NDMA builds up over time, it has the potential to cause cancer in human beings. The FDA has set the permissible daily intake limit for NDMA at 96 nanograms and a limit of 0.32 parts per million for NDMA in ranitidine products. Preliminary testing revealed NDMA levels as high as 2.17 parts per million in some drugs, with Zantac/Sanofi being one of the worst offenders.

What If I Have Been Taking Zantac?

If you have been taking Zantac, follow FDA recommendations and stop using the drug immediately.

Remember that NDMA takes time to build up, so if you only took Zantac occasionally, you have no reason to worry. On the other hand, extended use of Zantac could increase the amount of NDMA in your body and thus put you at an increased risk of cancer. Still, there are ways to address this risk.

If you have taken Zantac for one (1) year or more, please contact Brett H. Oppenheimer, PLLC today.

Mr. Oppenheimer can discuss your legal options with you, and if appropriate, our firm can help you pursue compensation that will account for your heightened risk, any diagnosis you may currently have, and any treatment you may need in the future.

For a free consultation, please contact us at (502) 242-8877 today or tell us about your defective drug case with this online contact form.

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