Do You Have a Probable Zantac Lawsuit? 

Zantac is one of the most popular over-the-counter heartburn medications sold in the US. But if you have been on the medication recently, you may have been exposed to a severe risk of cancer. 

The FDA announced in September 2019 that it was investigating into possible cancer risks in the popular heart medication. It was found that many Zantac products contain high levels of NDMA, a likely carcinogen. 

The carcinogen was found to be present in the medication at levels up to 3,000 times greater than the FDA recommends for daily intake. Since then, multiple ranitidine and Zantac manufacturers have recalled their products in the wake of the FDA’s advisory. 

If you or a loved one has been diagnosed with cancer, either of the bladder, colon, kidney, rectum, stomach or any other type after taking Zantac, you may have a claim for damages. 

At Oshan and Associates we have been investigating cases in which patients took Zantac or other forms of ranitidine and then developed cancer. If you suspect that you were put at risk due to the medication, contact us for a free case evaluation. The time to file your Zantac lawsuit is limited though, so you need to act fast. 

What does Zantac do? 

Zantac is the brand name for ranitidine, a histamine H2-receptor antagonist. The medication, also known as an H2 blocker, is commonly used by patients for heartburn relief associated with indigestion and sour stomach. 

The medication is also used to treat ulcers, gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome. The drug is available over-the-counter although it is also often prescribed. It may be administered orally or via injection into a muscle or vein. 

Ranitidine works by reducing the amount of acid the stomach produces. Ordinarily, the H2 receptors that are present on the stomach lining produce acid that helps the body digest food. Ranitidine blocks these receptors from producing their normal effect, leading to less acid production in the stomach. 

Since the patent on ranitidine lapsed, several drug manufacturers have produced generic versions of the medication. Zantac is still the most popular brand though, and it is manufactured and sold in the US by big pharmaceutical giants, Sanofi. 

Why has the drug been recalled recently? 

On September 13, 2019, the US Food and Drug Administration (FDA) announced that it was investigating possible cancer risks in popular heart burn medication, Zantac. The investigation was part of a wider inquiry into possible carcinogens in heart failure and blood pressure medication, in consequence of which it had recommended several recalls after finding unacceptable levels of contaminants. 

Valisure, an online pharmacy, had also conducted some inquiry into ranitidine as part of its internal processes since the spring of 2019. The pharmacy found “extremely high levels” of NDMA, a probable carcinogen, in ranitidine pills. 

The carcinogen was found at shockingly high levels in the pills, in excess of 3,000,000 ng per tablet. These levels are more than 3,000 times higher than the FDA’s established permissible intake of the toxin, 96 ng. 

Valisure submitted a citizen petition to the FDA on September 9, 2019, requesting that the FDA take action to protect public health, including by recalling all ranitidine products in the US. 

The FDA published its warning regarding the drug and less than two weeks later, 14 lots of the medication were recalled by Sandoz, a generic maker of the drug, sparking a wave of nationwide recalls. Since then, fourteen (14) recalls of ranitidine and Zantac have been announced including the following: 

• Appco Pharma LLC, recalling prescription ranitidine hydrochloride capsules, and Northwind Pharmaceuticals, recalling prescripton ranitidine (150 mg and 300 mg tablets) on January 8, 2020. 
• Mylan pharmaceuticals, recalling prescription nizatidine capsules on January 8, 2020.
• Glenmark Pharmaceutical Inc., recalling prescription ranitidine tablets (150 mg and 300 mg) on December 18, 2019. 
• Precision Dose, recalling ranitidine oral solution, USP 150 mg/10 ml on November 19, 2019. 

You can see all the latest recalls from manufacturers and reasons for the recalls on the FDA’s website here. 

What is NDMA and why is it in Zantac? 

NDMA is short for n-Nitrosodimethylamine. It is a nitrosamine impurity that may be formed from dimethylformamide (DMF) and is classified by the World Health Organization (WHO) as a probable carcinogen. The same conclusion has been reached by the International Agency for Research on Cancer (IARC). 

The impurity is also an environmental contaminant that can be found in water and food, especially smoked or charred meat. It is considered by the Environmental Protection Agency to be a potential carcinogen, with a high potential to cause cancer, as established by research in animals. 

NDMA was originally used to produce rocket fuel. However, when it was found that unusually high amounts of the substance were contaminating the water, air and soil around the fuel manufacturing plant, its use was stopped. 

Although research is still ongoing into the effects of NDMA on the human body and its cancer risk, there is no doubt that it is potentially harmful. And as this study shows, it is certain that NDMA is created in the body after oral intake of some ranitidine medications. The study found that urinary excretion of NDMA increased in the 5 male and female participants after oral intake of ranitidine. 

Research from Valisure found that NDMA was produced in the body as a result of “the inherent instability of the ranitidine molecule”. According to them, the carcinogen is a natural by-product of the ingredients used to make the drug. When ranitidine interacts with the stomach in a warm environment, the heat could potentially transform the drug into NDMA during the digestive process. 

While the FDA continues to test ranitidine products from multiple manufacturers and the potential impact on patients who have been taking the drug, France, Canada and other countries have recalled all forms of the drug from their markets. 

Who is at risk? 

If you regularly use ranitidine medications for the prevention or treatment of heartburn, ulcers and GERD, you may be at risk of carcinogen exposure. This would especially be the case if you have been taking the drug for a long period of time. 

Those that have been exposed to the medication may be at risk of the following types of cancer: 

• Stomach or gastric cancer
• Kidney cancer
• Bladder cancer
• Pancreatic cancer
• Colon or intestinal cancer
• Uterine cancer
• Esophageal cancer 
• Liver cancer 

Filing a Zantac lawsuit

If you were harmed because of your Zantac medications, you may have a dangerous drugs lawsuit. Manufacturers of drugs are expected to take absolute care and ensure that their products are fit for human consumption. If they have been negligent or reckless in this duty, they may be held liable in a court of law. 

Some lawsuits have already been filed against the makers of Zantac and generic ranitidine products. Cases have been filed against Zantac manufacturer, Sanoti-Aventis LLC and former owner of the rights to the drug, Boehringer Ingelheim. More cases are expected to be filed in the future. 

The plaintiffs are claiming that these manufacturers knew about the dangers in taking Zantac and yet failed to warn healthcare providers and patients. Many manufacturers continued to market the products as being safe, even with knowledge. 

If you or your loved one took Zantac or a generic ranitidine product and suffered cancer as a result, you may have a claim for damages in a Zantac lawsuit. 

Oshan and Associates is currently interviewing claimants and investigating cases of harm caused by Zantac. We invite you to contact us today to understand your rights and whether you have a claim for a Zantac lawsuit. Call us on (206) 335-3880 or (646) 421-4062 to speak with a lawyer today.