Zantac
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Maine Zantac Lawyer
Zantac (ranitidine) was once the top selling medication in the world, and has been used regularly by millions of Americans for decades for the treatment of heart burn and acid reflux. However, increasing evidence demonstrates that Zantac contains the probable human carcinogen N-nitrosodimethylamine (NDMA). Research also indicates that due to the unstable nature of Zantac’s active ingredient, ranitidine, the NDMA may convert to dangerous levels in the human body.
The United States Food and Drug Administration (FDA) and European health agencies are now investigating whether over-the-counter (OTC) and prescription brand versions of Zantac may cause high levels of NDMA to develop and increase in the users’ bodies. Research indicates that NDMA levels from Zantac may be up to 26,000 times higher than the legally permissible levels established by the FDA posing significant cancer and other health risks for patients.
Background on Zantac
Zantac (ranitidine) belongs to a class of older heartburn drugs, known as histamine-2 receptor antagonists. Other medications in this class include Pepcid AC and Tagamet. Ranitidine works to decrease the amount of acid created by the stomach. Over-the-counter Zantac is used to treat heartburn caused by acid indigestion. Prescription Zantac is indicated for treatment of gastroesophageal reflux disease (commonly known as GERD) and prevention of gastrointestinal ulcers.
Zantac’s Cancer Concerns
The problems with Zantac were first reported by Valisure, a Connecticut based online pharmacy, which filed a citizen’s petition with the FDA in September 2019, calling on regulators to withdraw the drug from the market. According to the independent testing conducted by Valisure, levels of NDMA in a single Zantac 150mg tablet may exceed 3,000,000 nanograms, which is 26,000 times higher than the FDA’s permissible daily exposure level for the chemical of 96 nanograms.
NDMA is a chemical used in gasoline, rocket fuel and other petroleum-based industrial products. NDMA is classified as a probable human carcinogen (i.e. a substance that could cause cancer).
Valisure’s testing, along with research being conducted at Stanford University and other institutions, found that NDMA was the result of the “inherent instability” of the ranitidine molecule. This means that any version of Zantac including all manufacturers (brand or generic), formulations (tablet, capsule, oral solution or injection), and manufacturing lots of ranitidine-containing medications are affected and may generate unsafe levels of NDMA in the human body.
NDMA is also the same contaminant that lead to numerous recalls of blood pressure medications including valsartan, irbesartan, and losartan. However, the problems with Zantac are different in a significant way. In the case of the blood pressure medications, the high levels of NDMA were traced back to a contamination problem caused by a change in manufacturing practices. In the case of Zantac, the problem is linked to the medication’s active ingredient.
Cancers Potentially Associated with Zantac
Due to the presence of NDMA in Zantac and NDMA’s propensity to convert to even higher levels in the stomach during digestion, Zantac may be associated with various digestive tract and related cancers including:
- Bladder cancer
- Breast cancer
- Colon/Colorectal cancer
- Esophageal/Nasal/Throat cancer
- Intestinal cancer
- Kidney cancer
- Liver cancer
- Ovarian cancer
- Pancreatic cancer
- Prostate cancer
- Stomach cancer
- Testicular cancer
- Thyroid cancer
- Uterine cancer
Zantac Recalls
On September 13, 2019, the FDA issued a Safety Notification warning that ranitidine-containing medications, including over-the-counter Zantac, were found to contain “unacceptable levels” of NDMA and asking manufacturers to conduct safety testing of their products.
In response, major retail pharmacies including CVS, Rite Aid, Walgreens, and Wal-Mart began pulling Zantac from store shelves. Manufacturers responded by ceasing all new distributions of Zantac to stores followed shortly thereafter by announcing recalls of their versions of Zantac from the market.
Novartis (through its generic division, Sandoz) was the first to recall their generic ranitidine-containing products sold in the U.S. followed by other generic manufacturers including Dr. Reddy’s Laboratories and Apotex.
On October 18, 2019, Sanofi, the maker of branded OTC Zantac, initiated a voluntary recall of all over-the-counter versions in U.S. This includes Zantac 150®, Zantac 150® Cool Mint, and Zantac 75®. Sanofi has also issued a voluntary recall of over-the-counter Zantac in Canada.
GlaxoSmithKline has also suspended sales of Zantac worldwide.
Zantac Litigation
A growing number of Zantac lawsuits are now being pursued by individuals diagnosed with stomach, intestinal, colorectal, esophageal, liver, kidney, bladder and other cancers impacting the digestive tract where NMDA produced by the digestion of Zantac passed through the body.
The lawsuits allege that Zantac is defectively designed because it contains ranitidine which due to its chemical instability can generate increasing levels of NDMA in the human body.
The lawsuits also allege that the manufacturers knew or should have been aware based on research dating back to the 1980’s that Zantac could produce unsafe levels of NDMA in the human body and that the companies failed to conduct adequate testing of their products.
The lawsuits seek significant compensation for injured plaintiffs including medical expenses, lost wages, pain and suffering, disability and permanent injury, punitive damages and wrongful death.
Zantac Cancer Lawsuit
If you or someone you love has been prescribed Zantac and diagnosed with cancer, you may be entitled to significant compensation for your injuries.
To speak with an experienced, Maine Zantac lawyer, contact Fitzgerald Law Group at (844) FITZ-LAW or (844) 348-9529, or complete the contact form on this website for a free, confidential, case assessment.
