Zantac is a very popular antacid drug that has been around since the 1980s. Millions of people have been using Zantac and generic equivalents daily for years. Recent lab testing of ranitidine (the active ingredient in Zantac) found that the drug contained very high levels of a chemical called NDMA. NDMA is known to cause cancer and in September 2019 the FDA issued a public safety warning about possible cancer risks from Zantac.
In the wake of the FDA safety warning, Zantac has been abruptly pulled from shelves across the country. Thousands of Zantac lawsuits will likely be filed over the next few years. Our firm is currently seeking new Zantac cases from former Zantac users who have been diagnosed with certain types of cancer.
Zantac (ranitidine) belongs to a family of drugs known as histamine-2 or H2 blockers. Ranitidine and other H2 blockers work by decreasing the amount of acid produced in the stomach. Zantac was first released as a prescription drug in the U.S. in the early 1980s. Now Zantac and various generic versions of ranitidine are available in both prescription and over-the-counter form. H2 blockers like Zantac are often called "antacids" and the OTC versions are commonly used to treat and prevent heartburn (gastroesophageal reflux). Prescription-strength Zantac is used for the treatment of very severe heartburn and more serious conditions such as stomach/intestinal ulcers and Zollinger-Ellison syndrome.
Zantac was originally developed and patented by the European pharmaceutical company Glaxo (n/k/a GlaxoSmithKline). It was first approved and released as a prescription drug in the United States in 1983. Glaxo invested millions in aggressively promoting the drug both to doctors and the general public. Zantac then went on to become one of the best-selling drugs in pharmaceutical history. In 1987, just 3 years after its release, Zantac became the very first drug to reach $1 billion in annual U.S. sales. One of the keys to the marketing strategy that made Zantac so successful was the emphasis that the drug was totally safe and harmless.
In 1996 Zantac was approved for over-the-counter sales and quickly became a very popular item at drugstores. A year later in 1997, the original patent protection on Zantac expired and generic versions of ranitidine first started hitting the U.S. market. Competition from generic equivalents has gradually eroded Zantac's sales, but it remains one of the bestselling antacid drugs. In 2018 sales of over-the-counter Zantac were $129 million.
The rights to manufacture and sell Zantac in the United States have changed hands many times over the last 20 years. In 2006 Glaxo sold the exclusive rights to manufacture and sell Zantac in the United States to the German company Boehringer Ingelheim Corp. Boehringer owned the exclusive rights to sell brand-name Zantac in the U.S. from 2006 to 2017 when it sold those rights to international pharmaceutical giant Sanofi. Sanofi currently holds the rights to sell Zantac in the United States.
N-Nitrosodimethylamine ("NDMA") is an unstable organic chemical that is usually is created unintentionally as a byproduct of certain industrial processes. NDMA is very toxic to the human body (especially the liver) and it has been recognized as a human carcinogen since the 1970s. The evidence that NDMA causes cancer is overwhelming and not in dispute. NDMA has repeatedly caused cancer in basically every single animal lab test performed on it over the last 40 years. NDMA is listed as a potent human carcinogen by the World Health Organization (WHO), the International Agency for Research on Cancer (IARC), the U.S. Environmental Protection Agency (EPA) and various other organizations. Most recently studies by WHO have definitively linked NDMA to gastric and colorectal cancer.
Over the years, the presence of NDMA in consumer products has prompted massive safety recalls, both voluntary and at the direction of the FDA. The most recent round of NDMA contamination recalls impacted the popular blood pressure drug, Valsartan. In the summer of 2018, several Chinese manufacturers of generic Valsartan discovered that their drug compounds were contaminated with unsafe levels of NDMA. The NDMA contamination was caused by a change in the manufacturing process and led to a massive recall of generic Valsartan.
The discovery of NDMA in generic Valsartan in 2018 caught the attention of Valisure, a pharmaceutical lab in Connecticut that performs quality testing on consumer drugs. In the spring of 2019, Valisure decided to perform independent testing of various antacid drugs because of prior reports suggesting that they might contain NDMA. The results of the Valisure testing came as a shock to everyone, except for these companies that may have suspected this problem for years.
The Valisure testing found that Zantac and other generic versions of ranitidine contained levels of NMDA that were off the charts. According to the FDA, the maximum safe level of daily NDMA exposure is 96 ng. The Valisure testing found that one OTC Zantac pill contained 2,511,469 ng of NDMA. This equated to roughly 26,000 times the maximum daily limit of NDMA. Valisure immediately reports its testing results to the FDA in July 2019.
In September 2019, the FDA announced that it had conducted its own testing on Zantac and generic ranitidine. The FDA testing also found NDMA in Zantac, but at much lower levels than the Valisure tests. Even the lower NDMA levels found in the FDA testing were considered "unacceptable" and led to a public safety warning. The FDA safety warning prompted an immediate reaction from retailers and manufacturers.
CVS, Walgreens, Rite Aid, Walmart, and other major stores have all suspended sales of Zantac and its generic equivalents. Several generic manufacturers have also voluntarily recalled their products in response to the FDA warning. To date, however, the FDA has balked at issuing a mandatory recall notice.
We are not the only ones trying to sort this out. In Europe in the EU, the European Medicines Agency (EMA) is assessing "whether patients using ranitidine are at any risk from NDMA and will provide information about this as soon as it is available." Health Canada is asking all companies to stop distributing ranitidine because the "evidence suggests that NDMA may be present in ranitidine, regardless of the manufacturer." France is recalling Zantac and other ranitidine products. Switzerland is taking it a step further and ceasing sales pending a full investigation. The United Kingdom's Department of Health has asked that all unexpired stocks of four types of Zantac be immediately returned. The world is acting. The FDA needs to get off the sideline.
People taking Zantac might have unknowingly been ingesting incredibly high levels of NDMA into their system on a daily basis. Even the lower levels of NDMA found in the FDA testing are alarming high, and much more than the accepted safe daily limits for NDMA. Given the known potential of NDMA to cause cancer in lab animals, Zantac users may be a significantly increased risk of various types of cancers.
NDMA ingestion from use of Zantac can cause all types of cancer, but there are certain cancers that are specifically linked to NDMA. These include liver cancer, and cancers involving the gastrointestinal system: stomach cancer, colorectal cancer, and intestinal cancer. Are many more types of cancer involved? Probably. We just do not know yet.
With the latest information that's come out about ranitidine, the future of Zantac is not looking good. It is arguably no longer about whether ranitidine could potentially be linked to cancer, it's about how many cancers it causes and how serious the threat is. With all the alternative treatments available for heartburn, it's likely that most drug stores will eventually pull all ranitidine products off the shelf.
Most legal experts are predicting a mass wave of Zantac lawsuits getting filed over the next few years which should lead to the creation of a Zantac MDL. To date, two Zantac lawsuits have already been filed in Federal Court in California.
None of the plaintiffs in these cases have actually been diagnosed with cancer. (Some lawyers want to be the first to file a lawsuit.) These two cases are likely just the tip of the tip of a gigantic mass-tort iceberg. Zantac and its generic equivalents were widely used. Literally millions of people in the U.S. used over-the-counter Zantac regularly for heartburn. These means that the size of potential Zantac plaintiffs will be larger than any other defective drug cases.
Drug companies fight back hard when their drugs are under attack, particularly when they are as profitable as things like Zantac. You can expect the drug manufacturers, particularly the generic manufacturers, to argue that there is preemption of any lawsuits because generic drugs have been held by the Supreme Court to be preempted in many cases. Why? The reason is that generic drugs must have a warning that is identical to their brand-name counterpart.
We don't think preemption will be a valid defense in the Zantac cases. Federal preemption is only a valid legal defense when plaintiffs are claiming that the drug was defectively designed. But the Zantac cases are significantly different because they will not involve typical design defect allegations. Rather the primary theory in the Zantac cases will be defective manufacture of the drug as opposed to the typical duty to warn theory that lawyers usually pursue in these types of lawsuits.
Prospective Zantac plaintiffs will include anyone who used Zantac on a regular basis for any extended period of time and was subsequently diagnosed with cancer. The strongest plaintiffs will be those diagnosed with specific types of cancer that are closely linked to NDMA and the gastrointestinal system which Zantac impacts. These include:
- Liver cancer
- Stomach Cancer
- Bladder Cancer
- Intestinal Cancer
- Colorectal Cancer
- Esophageal Cancer
Our firm is currently evaluating new Zantac cancer cases. If you used Zantac and were diagnosed with cancer, particularly any of the specific cancers listed above, we can help you. Contact our lawyers at 800-553-8082 of contact us online for a free case evaluation.