More Lawsuits Filed against Maker of Popular Heartburn Medication after April FDA Recall
Additional lawsuits have been filed against the manufacturers of Zantac, a popular medication used to treat heartburn and acid reflux. The new round of legal action comes after the US Food and Drug Administration (FDA) announced on April 1, 2020, that it is requesting manufacturers of the drug to remove it from the market immediately.
According to the FDA, the drug puts users at risk for exposure to N-Nitrosodimethylamine (NDMA), a known carcinogen. The use of the medication could result in exposure to unhealthy levels of NDMA. The FDA, the Environmental Protection Agency (EPA), and the World Health Organization (WHO) all classify NDMA as a cancer-causing substance.
Researchers found that some ranitidine medications showed increased levels of NDMA over time. This was especially problematic when the medications were stored at higher than room temperatures. The official recall comes nearly nine months after the online pharmacy and laboratory company, Valisure, submitted a petition requesting a recall and safe destruction of all ranitidine products, which is the generic version of Zantac.
Valisure conducted an independent study simulating the conditions of the stomach. To simulate the effect of ranitidine in the system, it mixed ranitidine with the gastric fluid and sodium nitrites that are present during the process digestion.
The study determined that when ranitidine is in this environment it results in the production of high amounts of NDMA. When exposed to the simulated a person’s stomach conditions, the ranitidine produced approximately 304,500 ng of NDMA. The FDA considers only 96 ng per day of NDMA exposure safe.
Voluntary recalls of Zantac and other ranitidine products resulted, but it wasn’t until April 2020 that the product was officially recalled in the United States by the FDA.
What is NDMA?
NDMA is a semi-volatile organic chemical found in both industrial and natural processes, including rocket fuel. It also forms as a byproduct of the chlorination of wastewater and drinking water. It is classified as a probable carcinogen due to how it modifies DNA. It has been shown to increase cancer risk in lab animals, but the risk to humans is not yet officially confirmed.
Ranitidine, which is the active ingredient in Zantac, has a molecular structure made up of nitrite and dimethylamine that makes it susceptible to naturally occurring NDMA under certain conditions.
Lawsuits continue to be filed against the companies responsible for making Zantac after users of the product developed cancer.
According to the growing number of lawsuits, plaintiffs were diagnosed with the following types of cancer after using products containing ranitidine:
Zantac and Ranitidine
Ranitidine, which is sold under the brand name Zantac is in a class of drugs called histamine H2-receptor antagonists or H2 blockers. They work by decreasing the acid produced in the stomach. It is used to treat heartburn, acid reflux, and a variety of other issues related to the esophagus, stomach, and gastrointestinal tract.
Zantac dosages vary between 75 and 150 mg, and once-daily 300 mg. It is sold over-the-counter and by prescription.
Zantac denies knowing that its product was dangerous for users. Scientists have known since the 1980s that there is a link between NDMA and cancer. There is also evidence that Zantac’s manufacturers concealed that it knew of the risk. This puts millions of the drug’s users at risk.
Who is at Risk for Cancers Related to the Use of Zantac?
Anyone who used Zantac or medications containing ranitidine is at risk. Zantac is categorized as a heartburn medication, but it is used to treat a variety of other conditions including:
- Gastric and duodenal ulcers
- Gastroesophageal reflux disease (GERD)
- Sour stomach
- Barrett’s esophagus
- Acid reflux
- Other issues
FDA Issues Recall for Ranitidine Heartburn Medications
Following notifications of the FDA’s findings in the fall of 2019, several of the companies involved in the manufacture and distribution of Zantac, including Novartis, GlaxoSmithKline, Sanofi, and Boehringer Ingelheim, began pulling the drug from the market. These actions came before the official FDA recall. At the time, the FDA was not calling for users of these medications to stop taking them.
In April 2020, an official recall was launched and the FDA began a serious effort to encourage people to stop using Zantac. Additionally, the agency urged manufacturers to immediately discontinue all prescription and OTC Zantac and ranitidine medications.