The FDA issued a warning that the popular heartburn drug Zantac had been found to contain N-nitrosodimethylamine, or NDMA, a known human carcinogen (cancer-causing substance).
This warning came after a pharmacy in Connecticut discovered elevated levels of NDMA while testing Zantac. It has been reported that the levels of cancer-causing NDMA are anywhere from 3,000 to 26,000 times higher than the legally allowable limit set by the FDA.
If you have been diagnosed with cancer after taking Zantac, you are not alone. Our lawyers have been contacted by hundreds of cancer victims who developed various forms of cancer after taking Zantac.
What is Zantac?
Zantac belongs to a group of medicines known as histamine-2 blockers that work by reducing the amount of acid your stomach produces, according to WebMD. Ranitidine is used to treat ulcers in the stomach and/or intestines, and also to prevent conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome and gastroesophageal reflux disease (GERD). Zantac is manufactured and marketed by Sanofi, a French multinational pharmaceutical company headquartered in Paris.
What’s the problem?
Global health regulators in Europe and the United States have begun to warn that Zantac contains a cancer-causing ingredient called NDMA. The Zantac warning came after a pharmacy in Connecticut discovered elevated levels of NDMA while testing Zantac.
It has been reported that the levels of cancer-causing NDMA are anywhere from 3,000 to 26,000 times higher than the legally allowable limit set by the FDA.
Has Zantac been recalled? Yes. Sanofi issued a recall for Zantac OTC in the U.S. and Canada over potential NDMA contamination on October 18, 2019.
Generic Zantac Recalls
- February 27, 2020 – American Health Packaging issues recall of ranitidine tablets, USP 150 mg, 100 count unit dose blisters over presence of of N-nitrosodimethylamine (NDMA) Impurity.
- December 17, 2019 – Glenmark Pharmaceuticals Inc. recalls all unexpired lots (150 mg & 300 mg) of its ranitidine tablets over potential NDMA contamination.
- November 19, 2019 – Precision Dose Inc. recalls 5 lots of Ranitidine Oral Solution over NDMA cancer risk.
- September 25, 2019 – Apotex Corp. issues recall for generic Zantac over cancer risk.
- September 23, 2019 – Sandoz recalls ranitidine for NDMA contamination.
Have Other Medications Been Recalled Over the Cancer Risk?
The FDA has recalled several other drugs due to NDMA contamination. These medications are called Angiotensin II Receptor Blockers (ARBs), which are used to treat blood pressure problems and heart failure. The agency has issued numerous recalls for NDMA contaminated ARBs including Valsartan, Diovan, Losartan, and Irbesartan.
Zantac Side Effects
Our lawyers are reviewing potential lawsuits for people who developed any form of cancer after taking Zantac:
- Liver cancer
- Kidney cancer
- Lung cancer
- Intestinal cancer
- Stomach cancer
- Pancreatic cancer
- Colon cancer
- Ovarian cancer
- Esophageal cancer
- Testicular Cancer
- And more
FDA Demands Nationwide Zantac, Generic Ranitidine Recall
The Food & Drug Administration has ordered Zantac and its generics to be removed from the U.S. market, saying the medications have been exposing consumers to a risk of cancer. The move comes 6 months after an independent lab issued a warning to the FDA about a risk of NDMA in Zantac, and nearly 3 months after another lab told the agency levels of NDMA could increase if Zantac is stored above room temperature.
“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” said Janet Woodcock, FDA director of the Center for Drug Evaluation and Research. “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”
Walmart, CVS, Rite Aid Pull Zantac Amid Cancer Fears
Some of America’s largest pharmacy chains have halted sales of Zantac since news of the potential NDMA contamination broke, according to The New York Times. Walmart, Rite Aid, CVS and Walgreens removed Zantac and its generic versions following the FDA’s warning that it had detected the cancer-causing toxin in samples of the drug.
A Walgreens spokesman said on Monday that the company had pulled Zantac from its shelves “while the FDA continues its review of the products.” A Rite Aid spokesman said the retailer was “in the process of removing Zantac and generic versions sold under the Rite Aid name from its shelves.”
What is NDMA?
N-nitrosodimethylamine is a semi-volatile organic chemical that belongs to a class of known potent carcinogens, according to the U.S. Environmental Protection Agency (EPA). The chemical is used in gasoline, as a stabilizer for industry materials, and as a lubricant additive. NDMA has also been used to make liquid rocket fuel, and is a byproduct of manufacturing certain pesticides and processing fish.
How Do Our Prescription Drugs Get Contaminated?
FDA’s investigation highlights the challenge federal regulators face when dealing with a global pharmaceutical industry that exports generic drugs from dozens of countries, nearly all of which follow vastly different processes in bringing their products to market, according to Bloomberg. Several of the medications recently found to be contaminated with NDMA are from China and India, raising questions about the safety protocol for drug-makers in those countries. Poor quality control and efforts to conceal manufacturing problems from U.S. health regulators have complicated oversight of pharmaceutical companies overseas.
How Carcinogens Got Into the Generic U.S. Drug Supply: Bloomberg Video
If you take Zantac, FDA is advising you to consult your physician with concerns about potential NDMA contamination, as well as your risk for getting cancer from the medication. Do not stop taking Zantac without talking to your doctor first, as doing so could also lead to serious side effects and/or adverse reactions.
Can I File a Class Action?
Although Schmidt & Clark, LLP, is a nationally recognized class action firm, we have decided against this type of litigation when it comes to pursuing Zantac lawsuits. Our lawyers feel that if there is a successful resolution to these cases, individual suits, not class actions will be the best way to get maximum payouts to our clients.
If you’ve been injured by Zantac, we know you’ve suffered emotionally and economically, and want to work with you personally to obtain the maximum compensation for the damages caused by your injuries. Contact us today to learn more about your legal rights.
Do I Have a Zantac Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zantac lawsuits. We are handling individual litigation nationwide and currently accepting new Zantac induced cancer cases in all 50 states.
Again, If you or a loved one was diagnosed with cancer after taking Zantac, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.