You have most likely heard that Zantac, a name-brand ranitidine medication used for treating acid reflux and heartburn, was voluntarily recalled when studies showed that it could potentially produce a known carcinogen when digested. The news was made public on September 13th when the Food and Drug Administration (FDA) released a statement warning consumers of the potential presence of NDMA in ranitidine. NDMA, short for N-Nitrosodimethylamine, is a probable human carcinogen that is used to create cancer in rats for cancer research. While they did not instruct consumers to immediately stop taking the medication, they suggested that those taking the drug regularly may want to explore alternative options.

The link between ranitidine and NDMA was discovered in a study run by Valisure, a pharmaceutical company that independently researches and tests every medication they offer in order to guarantee its safety. Valisure first made the FDA aware of the potential risk back in June of 2019, but the FDA failed to make any public statements. That is until Valisure published their concerns in a petition to the FDA that detailed their findings and demanded the FDA to act and protect consumers.

Since the FDA made the findings public, voluntary recalls were announced from nearly every manufacturer of ranitidine including Sanofi, the manufacturer of the drug’s largest brand-name: Zantac. Along with recalls from numerous manufacturers, nearly all pharmacies within the U.S. announced that they have taken the product off their shelves indefinitely. While the manufacturers maintain that the drug is safe to consume, they are voluntarily pulling it off shelves until there is further testing that can conclude whether the prescription medication, as well as the over-the-counter (OTC) medication, is safe.

Numerous lawsuits filed

The alarming results of Valisure’s study have triggered several lawsuits against manufacturers of ranitidine. One of those plaintiffs, Joseph Galimidi, stated that Sanofi was aware of the dangers of taking Zantac and “failed to adequately warn against the negative effects and risks associated with Ranitidine products, including Zantac” (1). Galimidi, a Florida resident, is suing Sanofi for failure to warn him of the risks and that it resulted in him developing breast cancer after regularly taking Zantac for several years to treat his heartburn and acid reflux.

In another lawsuit, Pedram Esfandiary of Baum, Hedlund, Aristel & Goldman PC, was similarly convinced that the makers of Zantac were either aware or willfully ignorant of the potential dangers of ranitidine. He stated that “the carcinogenic potential of Zantac has been deliberately obfuscated, ignored and/or overlooked for decades despite substantial evidence that Zantac releases the powerful carcinogen, NDMA, when ingested by the human body" (2). Although it is still to be seen if the prosecution has enough evidence to substantiate these allegations.

How much NDMA is "acceptable?"

More importantly, there has yet to be any agreement on how much NDMA ranitidine produces when it is ingested. While NDMA can regularly be found in the food and water we consume, it is only present in relatively small quantities. Because of its carcinogenic nature, the FDA has placed a strict limit that no pharmaceutical can exceed 96 nanograms (ng) of NDMA per daily intake. You can imagine the shock that Valisure’s scientists must have had when their tests showed the presence of 304,500 ng of NDMA after a single 150 mg tablet of ranitidine entered a simulated digestive system where nitrates were present.

If these initial studies are accurate, a 150mg dose of ranitidine could potentially produce 3,100 times the amount of NDMA that the FDA has deemed an “acceptable” level to be found in pharmaceutical medications. If that wasn’t worrisome enough, some tests have indicated that may only be a fraction of the potential NDMA produced when ranitidine is ingested (3).

Those that were prescribed Zantac, any of its generic counterparts, or took the OTC version may have been exposed to extremely dangerous amounts of NDMA over sustained amounts of time. In a Colorado federal court, Mark Allan Blake argued based on Valisure’s study that, “a person would need to smoke at least 6,200 cigarettes to achieve the same levels of NDMA found in one 150 mg dose of Zantac” (4).

The tip of the iceberg

While these lawsuits are still in the beginning stages, some lawyers are predicting that this is just the tip of the iceberg. For the past decade, doctors have written between 15 and 17 million prescriptions each year for ranitidine, which has been on the market since 1981. The volume of potential victims that may have been affected by taking ranitidine is staggering. Bret Wisner, a legal representative of Blake, was quoted saying, “For the last 40 years, people have been ingesting a drug that produces astronomical levels of NDMA in the body. The number of cancers that Zantac has caused over the last 40 years, could very well reach into the millions” (5).

We will be monitoring the progress of these trials and regularly update you on how they are developing. The decisions made in these initial trials will be a strong indication of how future trials will be handled and how many people may have been affected.

If you or someone you loved has developed cancer while taking Zantac or any other generic brand of ranitidine, you may be eligible for substantial compensation.

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1 https://www.law360.com/articles/1199481/sanofi-faces-1st-us-suit-over-likely-carcinogen-in-zantac

2 https://www.law360.com/articles/1212031/pfizer-sanofi-sued-over-possible-zantac-cancer-link

3 https://www.valisure.com/wp-content/uploads/Valisure-Ranitidine-FDA-Citizen-Petition-v4.12.pdf

4 https://www.law360.com/articles/1212031/pfizer-sanofi-sued-over-possible-zantac-cancer-link

5 https://www.law360.com/articles/1212031/pfizer-sanofi-sued-over-possible-zantac-cancer-link

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