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Spangenberg Shibley & Liber LLP | Mar 30, 2020

The Dangers of NDMA in Zantac & Why the FDA Recommended a Recall

Categories: Product Liability, Zantac

Zantac is one of the world’s most popular heartburn and ulcer relief medicines that relies on the drug ranitidine. Users can purchase Zantac off-the-shelf of most pharmacies and grocery stores, or they can get it through a prescription from their doctors.

Recently, the Food and Drug Administration (FDA) released studies that found certain batches of Zantac would expose users to detectable amounts of N-Nitrosodimethylamine, more frequently called NDMA. If you recognize the acronym NDMA, then you likely recognize it as a known carcinogen or cancer-causing agent. After high NDMA levels were identified in Zantac users, its manufacturers issued a number of voluntary recalls before the FDA could order mandatory recalls.

Why Should You Be Worried About NDMA?

The FDA has been able to identify a probable link between NDMA exposure and cancer in laboratory studies involving test animals. Only relatively small amounts of exposure to the substance seemed to be able to trigger various types of cancerous growth during the tests.

The different types of cancer believed to be caused by ingested NDMA include:

  • Liver cancer
  • Stomach cancer
  • Kidney cancer
  • Intestinal cancer

It is believed that any amount of NDMA significant enough to be detectable in a test could cause cancer. Since the FDA was able to identify the substance in large amounts after a user took a single Zantac tablet, it stands to suggest that the amounts are dangerous to humans. Microscopic amounts of NDMA can also be detected in most meats after they have been smoked or grilled over an open fire, which might suggest the tentative link between stomach cancer and diets heavy with red meats.

Zantac Exceeds FDA Limits on NDMA Exposure

Currently, the FDA suggests that no one ingest more than 96 nanograms of NDMA a day due to its carcinogenic properties. A study performed by a Valisure and coinciding with Stanford University research, which was forwarded to the FDA, revealed that the typical 150 milligram Zantac capsule or pill would exposure a user to around 2.7 million nanograms of NDMA. In other words, even if a user consumed just 1/28,000th of a Zantac pill, they would still reach the FDA’s NDMA exposure limit. To make the situation more alarming, most users take more than one Zantac pill in a day.

Will the FDA Issue a Mandatory Zantac Recall?

At this time, the FDA is still looking into the potential cancer-causing dangers of Zantac. It announced in October 2019 it would not only continue research but also that more manufacturers should voluntarily recall their ranitidine-based products like Zantac. A few ranitidine drug manufacturers have agreed to voluntarily recall their products, including Sandoz, Inc., Glenmark Pharmaceutical Inc., and Apotex Corp.

However, the FDA has not issued a mandatory Zantac recall yet. The agency must wait for clearer evidence of NDMA exposure and cancer risk before forcing manufacturers to take their products off shelves.

Can You Sue Zantac Without a Mandatory Recall?

Consumers have the right to bring lawsuits against Zantac. In fact, several noteworthy claims have already been filed and multidistrict litigation may soon form.

The lawsuits being filed against Zantac are not based on cancer claims, though, since the medical evidence is still a bit foggy. Instead, consumers are suing Zantac and its manufacturers for dishonest business practices and consumer fraud. Evidence of Zantac’s potential NDMA dangers existed for a long while, yet Big Pharma did not warn consumers at all nor did they change their product packaging. Consumers were left believing that Zantac had no serious potential side effects and continued to purchase it unknowingly, and doctors continued to prescribe it without knowing that it could be hurting their patients.

To this end, lawsuits against Zantac are absolutely possible at this time, and they may only be strengthened in the months or years to come as further medical evidence emerges. If you have more questions about Zantac lawsuits and your rights as a ranitidine user, Spangenberg Shibley & Liber LLP in Cleveland can help. We are hearing from locals who have used Zantac without knowing its dangers until the FDA prompted voluntary Zantac recalls from several manufacturers and distributors.

Call (216) 600-0114 now to discuss your case with our Zantac lawsuit attorneys.