What is Zantac?
Zantac is a brand of ranitidine that may be prescribed to treat ulcers of the stomach and intestine and to keep them from returning. It is also used to treat several other digestive problems, including the following:
- Acid indigestion
- Acid reflux
- Difficulty swallowing
- Stomach pain
- Zollinger-Ellison syndrome
- Multiple endocrine neoplasia
In the 1980s, Zantac was only available by prescription. However, it was approved for sale as an over-the-counter medication in 1995. The doses of the OTC version of Zantac were one-half of the strength of the prescription drug. Millions of people have relied on Zantac to relieve symptoms of digestive problems, believing it to be safe. However, research has shown that this drug may contain NDMA, a carcinogenic substance. The drug has also been shown to interact with other substances that might be present in the human body to form NDMA after people take it.
Valisure discovers NDMA in Zantac and ranitidine
Valisure, a private Connecticut-based company, tested Zantac and ranitidine tablets. The company found that several forms of the drug contained NDMA and alerted the federal Food and Drug Administration of its discovery in 2019. Studies as early as the late 1980s had revealed that ranitidine could react with nitrites to form NDMA in the body. Nitrites are substances that are present in processed meats like bacon or hot dogs, which are the types of foods that might prompt people to take ranitidine because of heartburn and indigestion caused by eating them.
Studies in the 2000s revealed that ranitidine is unstable and its DMA group can potentially form NDMA in the presence of oxidation. Valisure’s discovery came in 2019 when it found that ranitidine can react with itself and form millions of nanograms of NDMA.
In 2004, the National Cancer Institute found a correlation between taking certain antacids, including cimetidine and ranitidine, and the development of bladder cancer. As of 2019, Valisure is working with Memorial Sloan Kettering Cancer Center to complete epidemiological studies of ranitidine use and cancer.
Recall of Zantac
The FDA issued a statement on Sept. 13, 2019, about the potential cancer risks of Zantac and ranitidine. Following the statement, Sanofi issued a recall of Zantac to pull it from retailers’ shelves. Several generic drugmakers followed suit, recalling generic versions of the drugs from retailers’ shelves.
The FDA tested 1,500 samples of ranitidine and found higher levels of NDMA than the levels that are deemed acceptable. Following the FDA’s statement, Canada, several European countries, Taiwan, and Pakistan ended the distribution of ranitidine. The FDA has not issued a mandatory recall. Instead, there have been voluntary recalls by some companies that manufacture the drug. The FDA is continuing to test samples and to post results for regulators around the world.
What is NDMA?
N-nitrosodimethylamine or NDMA is a hazardous substance that is used in aviation, industrial lubricants, and rocket fuel. It is also a byproduct of wastewater treatment, gasoline refining, and other industrial processes. NDMA is a known carcinogen that has been linked to cancer for more than 40 years. Studies in the late 1980s demonstrated that ranitidine might form NDMA in the stomach by reacting with nitrites. Despite this, drugmakers failed to disclose the potential risk of cancer caused by NDMA exposure to patients who took Zantac or other medications containing ranitidine.
Symptoms of overexposure to NDMA
There are several symptoms of overexposure to NDMA, including the following:
- Abdominal cramps
- Potential development of cancer
- Reduced functioning of the lungs and kidneys
If you experience any of these symptoms after taking Zantac or another medication that contains ranitidine, you should talk to your doctor as soon as possible.
Zantac and ranitidine cancer claims
Zantac and ranitidine cancer claims are based on theories of product liability. When people use products that are sold on the market in the manner in which they were intended to be used and are injured as a result, the parties that are responsible for placing the products on the market may be liable to pay damages. Several parties may be liable in a product liability claim, including the manufacturer, the distributor, the designer, the retailer, and others that are involved in the chain of distribution.
As we have previously discussed, there are three categories of product liability claims for defective products. Design defects occur when an inherent risk of a product outweighs its potential benefits. Manufacturing defects are defects that occur during the manufacturing process. Failures to warn or inadequate warnings occur when a manufacturer fails to warn consumers of the risks or provides inadequate warnings.
Dangerous drug claims such as potential Zantac and ranitidine cancer lawsuits might include claims based on design defects and inadequate warnings. For example, you might be able to argue that the benefits or ranitidine for digestive issues are outweighed by the risk of developing cancer. Many claims will likely rely on the inadequate warnings and failures to warn consumers and health care professionals of the risks of developing cancer after taking Zantac or ranitidine. Despite studies dating back to the late 1980s that showed that ranitidine might form NDMA in the stomach when exposed to nitrites, the companies that manufactured the medication failed to include adequate warnings of the risks.
Zantac was a huge moneymaker for drug manufacturers. According to an article in the New York Times in 1988, Glaxo Inc. made more than $1 billion in sales of Zantac in 1987 alone and was expected to reach $1.7 billion in sales in 1988. As a very popular drug, it promised to return staggering profits to the companies that manufactured it. This might have led some of the companies to conceal the link between ranitidine and the risk of cancer.
What to do if you have developed cancer after taking Zantac or ranitidine
If you are diagnosed with cancer after taking Zantac or ranitidine, you should follow all of your doctor’s treatment recommendations. You might also want to talk to the experienced product liability and dangerous drug attorneys at Steven M. Sweat Personal Injury Lawyers APC. Our attorneys can review your medical records and other evidence in your case to determine whether you might have a valid claim. If you do, you might be entitled to recover damages to compensate you for your losses. Contact us today to schedule a confidential consultation by calling us at 866.966.5240 or by filling out your information in our contact form.