Defective drugs lawyers - Zantac

What carcinogenic chemical was found in Zantac, the most popular brand of ranitidine?

The U.S. FDA last fall reported that some medications, including some products commonly known as the brand-name drug Zantac, contain a potentially dangerous chemical, NDMA (scientific name N-Nitroso-dimethylamine) at unsafe levels. Nitrosodimethylamine, classified as a probable human carcinogen based on the results of laboratory tests, is a semi-volatile organic chemical that can form naturally through industrial processes. NDMA was formally used in aviation and rocket fuel and industrial lubricants. It can also be found in water as well as meat, dairy, and vegetables. 

During its routine testing of every batch of every medication, Valisure, America’s first analytical pharmacy to chemically validate medications and ensure their quality and safety, discovered the link of Zantac and its generics to the carcinogen NDMA, and first notified the FDA of its initial findings in June of 2019. The online pharmacy based in Connecticut, also claimed that the NDMA is likely formed as the result of the inherent instability of the ranitidine molecule. Although the FDA advisory states that the level of contamination is “low,” Valisure has detected NDMA in excess of 3,000,000 ng per tablet, a level likely much higher than what the agency has determined to be reasonably safe for human ingestion based on lifetime exposure.

Ranitidine, the active ingredient in Zantac, has a molecular structure that makes it susceptible to naturally creating NDMA once it is ingested. The ranitidine molecule contains nitrite and dimethylamine, two elements well known for producing NDMA under the right conditions. Specifically, when the ranitidine interacts with the gastric fluid and sodium nitrites found in the stomach, high amounts of NDMA are produced.

Zantac side effects that lead to claims

NDMA is known to cause cancer in animals, and the U.S. Environmental Protection Agency classified N-nitrosodimethylamine as a Group B2 - probable human carcinogen, based on the induction of tumors in both rodents and nonrodent mammals exposed to NDMA by various routes. At high levels, the chemical has resulted in liver toxicity in rats, and chronic low doses have also been linked to liver and esophageal tumors in the animals.

NDMA acts as a carcinogen because it has the capacity to induce structural changes in cellular DNA. Exposure to high amounts of NDMA has been linked to various cancers, including:

• Bladder Cancer
• Pancreatic Cancer
• Breast Cancer
• Prostate Cancer
• Colorectal Cancer
• Kidney Cancer
• Stomach Cancer
• Liver Cancer
• Testicular Cancer
• Lung Cancer
• Thyroid Cancer
• Ovarian Cancer
• Uterine Cancer

The health effects of overexposure to NDMA include hepatitis, liver failure, and jaundice, skin rashes, hair loss, nausea, fever, vomiting, abdominal cramps, and dizziness. Please talk to your doctor if you have taken Zantac and experience these side effects.

Drug companies that make Zantac and its generic varieties have pulled their drugs off the market

Ranitidine, the generic equivalent of Zantac, has been listed on the World Health Organization’s List of Essential Medicines, and as of 2016 was the 50th most prescribed medication in the United States with more than 15 million prescriptions.

In September 2019, the toxin N-nitrosodimethylamine was discovered to occur in ranitidine from a number of manufacturers, resulting in distribution stops and recalls as a precautionary measure. Soon after that, a number of manufacturers recalled their Zantac and ranitidine products due to the belief that the drugs can naturally produce high levels of NDMA as a byproduct of the digestion process. For example, Sandoz, a generic maker of the drug, recalled 14 lots of ranitidine hydrochloride capsules because of confirmed contamination of NDMA above levels deemed safe by the FDA.

Other generic makers like Glaxo-Smith-Kline and Dr. Reddy’s Laboratories stopped shipping their ranitidine products but stopped short of implementing any recalls. Recently, two class-action lawsuits were filed against Zantac manufacturer Sanofi-Aventis LLC and Boehringer Ingelheim Pharmaceuticals, who previously held rights to Zantac, with plaintiffs claiming that the companies knowingly put patients' health at risk.

Legal help for people who unknowingly take dangerous drugs

Peer-reviewed studies published on the topic of ranitidine and NDMA suggest that Zantac maker Sanofi and other drugmakers knew - or should have known - that Zantac use potentially exposes users to NDMA.

 “Since 2002, the formation of NDMA by the reaction of DMA and a nitroso source (such as nitrite) has been well characterized in the scientific literature", Valisure further wrote in its FDA petition.

The first Zantac lawsuit was filed in California the day the FDA issued its advisory. Plaintiffs accuse drugmakers Sanofi and Boehringer Ingelheim for:

• manufacturing, marketing, and selling a product they knew or should have known had been contaminated with an industrial chemical known to cause cancer
• Failing to warn consumers and doctors about the known risks of the drug
• Misrepresenting the drug as a safe and effective remedy for common ailments 

Anyone who has taken Zantac or generic ranitidine and has been diagnosed with cancer may be eligible for legal action against manufacturers. We are committed to promoting safety through accountability!

At Environmental Litigation Group we understand that drug manufacturers are supposed to manufacture safe drugs and warn consumers of any risks. A defective drug can harm you and impact the lives of you and your family, by causing physical and emotional pain, unnecessary medical costs and missed work.

Our attorneys hold drug manufacturers responsible when illnesses from a defective drug occur. If you have been taking Zantac, or another variation of Ranitidine, and have been diagnosed with cancer, call the experienced lawyers at Environmental Litigation Group, to learn about your options. We can help by:

• Evaluating your claim at your free consultation
• Investigating the drug in question
• Consulting with medical experts for learned advice and testimony
• Pursuing compensation for past and future medical expenses, loss of earning capacity, loss of enjoyment of life, and for the pain and suffering caused by the permanent or temporary disability.

Call 205.328.9200 Case Evaluation