Popular heartburn medication Zantac (ranitidine) has tested positive for a substance linked to cancer, leading to manufacturer recalls, pharmacies pulling the products from their shelves, and a widening probe of the issue.
Our attorneys are investigating claims that Zantac and other ranitidine medications could cause cancer. This is a potentially serious issue for the millions of people who use the drug. Patients are encouraged to speak with their physician about treatment alternatives and to report adverse side effects to the Food and Drug Administration (FDA).
If you take Zantac, you may also wish to speak with an attorney about possible legal action. This is a developing situation, but our nationally recognized dangerous-drug attorneys stand ready to file lawsuits on behalf of Zantac patients diagnosed with cancer.
WHY WAS ZANTAC RECALLED?
Drugmaker Sanofi announced in an October press release that it will conduct a voluntary recall of Zantac OTC (over the counter, meaning without a prescription) in the U.S. and Canada due to “possible contamination with a nitrosamine impurity called N-nitrosodimethylamine (NDMA).” Sanofi, which calls the move “precautionary,” said drug evaluations are ongoing and that anyone using Zantac OTC should speak with their healthcare providers or pharmacists if they have additional questions.
In addition to the Zantac recall, drug manufacturers Apotex and Novartis are recalling generic ranitidine products sold in the U.S. Major chains CVS, Walgreens, and Walmart have also pulled Zantac and its generic versions from their shelves.
Doctors write more than 15 million ranitidine prescriptions each year, while countless more patients buy the drug over the counter. Prescription ranitidine is approved for treatments that include ulcers and gastroesophageal reflux disease. OTC ranitidine is approved to prevent and relieve heartburn associated with indigestion.
WHAT IS NDMA, AND WHAT ARE ITS RISKS?
NDMA is an environmental contaminant found in water and foods including dairy products, vegetables, and meats. It’s classified as a probable human carcinogen based on animal studies. NDMA research in humans is very limited. The FDA, the Environmental Protection Agency, and the World Health Organization classify NDMA as a carcinogen.
Harvard Medical School noted that NDMA “may cause cancer only after exposure to high doses over a long period of time.” According to the Centers for Disease Control, NDMA is very harmful to the liver of animals and humans. It has been linked to severe liver disease as well as testicular, liver, and lung cancer. “Exposure to NDMA by eating, drinking, or breathing could cause cancer in humans,” the agency said.
NDMA is the same carcinogenic impurity that has been found in blood pressure and heart medications such as Valsartan. Those drugs were contaminated through purported manufacturing flaws at pharmaceutical plants in China and India. Preliminary testing suggests that NDMA in ranitidine may result from the molecular structure of ranitidine.
HOW WAS THE IMPURITY DISCOVERED?
Valisure, a Connecticut-based online pharmacy, informed the FDA that its testing had detected NDMA in multiple ranitidine products. In a letter to the agency, Valisure stated that it found “extremely high levels” of NDMA in every lot tested across multiple manufacturers and dosage forms of ranitidine. The company requested that the FDA recall and suspend sales of all lots of ranitidine products.
The FDA’s permissible daily intake of NDMA is 96 nanograms (one billionth of a gram), the letter stated. Valisure’s testing detected NDMA in excess of 3,000,000 nanograms per tablet — more than 31,000 times higher than FDA limits. Valisure hypothesized that the NDMA it found is “likely due to an inherent instability of the ranitidine molecule.”
WHAT DOES THE FDA SAY ABOUT ZANTAC AND NDMA?
Several days after receiving a petition from Valisure about its ranitidine concerns, the FDA issued a statement saying that it was looking into the matter. A later statement indicated that the FDA’s own preliminary testing had detected levels of NDMA in ranitidine lower than those detected by Valisure.
While the FDA is not currently calling for patients to stop taking ranitidine, it noted that other OTC medicines approved for their condition are available. FDA testing of Zantac alternatives such as Pepcid, Tagamet, Nexium, Prevacid, and Prilosec has shown no NDMA.
IS THERE OTHER SCIENTIFIC EVIDENCE THAT LINKS ZANTAC AND NDMA?
Peer-reviewed studies have been published on the topic of ranitidine and NDMA. These studies suggest that Sanofi knew — or had reason to know — that Zantac use potentially exposes users to NDMA.
A 2016 study published in the academic journal Carcinogenesis found that patients who took ranitidine had a 400-fold increase of NDMA concentration in their urine. Other studies, including those published in Chemosphere and Environmental Science & Technology, have shown that ranitidine is a possible NDMA precursor (in chemistry, a precursor is a substance from which another substance is formed).
WHO CAN FILE A ZANTAC LAWSUIT?
Any patient who has taken Zantac and/or a generic version of the drug as prescribed by their physician and has been diagnosed with cancer may be eligible for legal action against manufacturers.
WHAT COMPENSATION IS AVAILABLE FROM A ZANTAC LAWSUIT?
Both economic damages (such as medical bills, lost wages, and other financial losses), as well as noneconomic damages (for conditions like physical and mental pain and suffering) could be available to Zantac plaintiffs. The actual compensation a plaintiff is eligible to receive depends on the facts surrounding their case.
WHY DO I NEED A LAWYER?
Pharmaceutical companies are among the wealthiest and most powerful organizations in the world. Taking on a drug manufacturer without legal representation is an extremely difficult path. To have the best chance at being fairly compensated, you should work with a law firm that has the experience and resources needed to stand up to Big Pharma.
HOW DO I KNOW IF I HAVE A CASE?
If you were diagnosed with cancer after taking Zantac, consider speaking with an attorney who can evaluate your case and help assess your legal options. As we continue our investigation into Zantac and NDMA, we invite you to contact us for a free legal consultation. If we file a lawsuit on your behalf, you pay no out-of-pocket legal fees and no costs at all unless we recover money for you.