Zantac Contamination: How Did it Happen? The Journey from Prescription to Poison

The voyage a medication makes from factory to pharmacy can be long. Now it turns out that the journey itself can transform a common antacid from heartburn helper to cancer-causing carcinogen. Unfortunately, such has been the case for medications containing ranitidine, including brand name Zantac and its generic forms.

Sanofi, the manufacturer of Zantac, and the makers of its generic equivalents, GlaxoSmithKline, Teva, Glenmark and others, were aware that the main ingredient in their antacid, ranitidine, undergoes a chemical reaction when exposed to mild heat that increases the amount of a cancer-causing toxin already present in the drug. Yet they did nothing to warn patients of the possibility that their acid reflux preventative might become hazardous for human consumption between the time it leaves the factory and the time it gets to your medicine cabinet.

A Health Hazard

When Zantac or other ranitidine tablets, capsules or liquid solutions are manufactured, each dose contains an amount of N-Nitrosodimethylamine (NDMA) at levels considered harmless by the U.S. Food and Drug Administration (FDA). However, NDMA is a volatile, combustible substance whose poisonous attributes increase when exposed to heat, which can occur during various chemical processes, including the manufacture of ranitidine.

At high doses, NDMA is a potent hepatotoxin that can cause various forms of cancers, including liver cancer, and other fatal diseases. In fact, NDMA has been labeled a potential human carcinogen by the FDA.So how does a seemingly harmless product turn into a potentially harmful one?.

From Factory to Pharmacy

Some Zantac is manufactured in Australia, where summer temperatures can exceed 139 degrees Fahrenheit. Generic ranitidine is manufactured in India, where summer highs can reach 123 degrees Fahrenheit. There is no instruction on the packaging that ranitidine products must be kept refrigerated – or even cool.

After manufacturing, the medication might sit inside a sweltering cargo container for hours or days at a time as it awaits shipment overseas to the U.S. from its country of origin. Then the blister packs or bottles sit in shipping crates stacked above deck in the sun as they cross the ocean, and they sit again on U.S. soil before being loaded onto trucks or trains for transport to your local pharmacy.

While inside those tractor-trailers and railroad cars bound for your local drugstore, interior temperatures can soar, exposing the medicine to excessive heat yet again. Once Zantac gets to your pharmacy, the antacid may have been exposed to extreme warmth a number of times, all before reaching the medicine cabinet in your steamy bathroom.

An Investigation

The FDA revealed in October 2019 that Valisure Laboratories conducted an investigation of Zantac and its generic equivalents and found that the ranitidine molecule may not be heat stable, generating “significant amounts” of NDMA under elevated temperatures. After analyzing batches of the heartburn medicine made by different manufacturers and of various doses, Valisure reported it “detected extremely high levels” of NDMA in every lot of ranitidine tested.

How NDMA Is Harmful

Until the recall, an estimated 15 million Americans were prescribed Zantac and other ranitidine drugs. That’s a lot of medicine cabinets full of Zantac and its generic equivalent. When taken, the NDMA in ranitidine is absorbed by the gastrointestinal tract, creating a situation in which the act of swallowing a pill meant to calm the digestive tract becomes the vector by which the toxin in the pill is absorbed.

When your body digests and metabolizes the NDMA in ranitidine, the poison inflames your liver. Those who drink alcohol are even more at risk, as the liver’s ability to reject metabolism of the toxin is reduced by the presence of ethanol-inducible liver cytochromes. In addition to an increase in the possibility of developing liver cancer, the kidneys and lungs also absorb NDMA at higher rates. This raises the possibility of cancer developing in those organs, as well.

As a result of the report from Valisure Laboratories, the FDA issued a directive asking manufacturers of ranitidine products to “expand their testing for NDMA to include all lots of the medication before making them available to consumers”.

Then Things Got Worse

In early 2020, another laboratory, Emery Pharma in Alameda, California, also tested Zantac and other ranitidine products. It found that, over time, ranitidine generates increasing amounts of NDMA, simply by sitting at room temperature.

Emery recommended that the FDA recall and suspend sales of all products containing ranitidine and provide information to the public regarding its instability at high temperatures. Furthermore, the laboratory urged the FDA to issue guidance on proper disposal of Zantac that consumers had already purchased, explaining that NDMA can impact the public water supply if flushed down the toilet or thrown in the garbage.

The new report recommended that ranitidine drugs be “cold-chained”, i.e., shipped in temperature-controlled trucks and stored under refrigeration, and labeled with clear warnings regarding storage conditions. Emery Pharma also suggested that product packaging be required to carry a temperature indicator label that informs consumers of excessive exposure to heat. Around the same time, the National Institutes of Health also recommended that pills containing NDMA should be stored in dark packaging to avoid exposure to ultraviolet light.

A Recall

On April 1, 2020, the FDA requested that all ranitidine products, including Zantac, be pulled from the market. The request includes prescription and over-the-counter (OTC) Zantac products. On April 23, 2020, the Department of Commerce and Consumer Affairs (DCCA) reminded consumers not to use ranitidine medication following the previous recall.

Signs of NDMA Overexposure

According to the Centers for Disease Control and Prevention and the National Institute for Occupational Safety and Health, potential symptoms of overexposure to NDMA include nausea, vomiting, weakness, diarrhea, abdominal cramps, headache, fever, jaundice, GI hemorrhage and enlarged and reduced function of liver, kidneys and lungs. Those who use Zantac regularly must contact their doctor before discontinuing use, as rebound acid reflux symptoms may occur.

The Zantac attorneys at Baron & Budd are dedicated to getting those who have suffered as a result of taking Zantac the compensation they deserve. If you or a loved one has been diagnosed with cancer as a result of taking Zantac or any ranitidine product, please call us at 866-723-1890 or complete our online contact form to arrange a no-obligation case review and free consultation.