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China And India Could Be The Source of Zantac Contamination

Identifying the source of NDMA contamination is critical if Zantac and other drugs are ever to return to the market

Monday, November 2, 2020 - The US Food and Drug Administration has recalled several high blood pressure medications, heartburn, and acid reflux medicines, and also type-2 diabetes drugs from the market in the United States after testing and finding high levels of NDMA, a substance known to cause cancer. Thousands of individuals with cancer are filing lawsuits against drug manufacturers like Sanofi, the maker of Zantac, for failing to warn patients of the cancer risks of taking their drugs regularly and for more than one year. Individuals that were taking any of the above medicines are urged to seek the guidance of their physicians for alternative medications and also may benefit by implementing positive, healthy, lifestyle changes such as eating a more plant-based diet and exercising regularly. Zantac cancer lawyers offer free, no-obligation consultations to Zantac users that now have cancer.

The issue remains that the exact cause of the elevated levels of NDMA can not be pinpointed as of the time of this writing. Researchers suspect that higher drug storage temperatures may be to blame for NDMA changes. Others think that NDMA increases when it is mixed in the stomach with nitrites, ironically the chemical meat preservative that one takes an antacid drug to alleviate in the first place. The most plausible reason for NDMA increases, however, is exposure during the manufacturing process in China and India where industrial pollution is the highest and environmental regulation mostly non-existent. NDMA is an industrial pollutant found in high concentrations in the air, land, and water in China and India. Both China and India are major suppliers to the global drug markets. According to Reuters, "Overall, more than two-thirds of all active drug ingredients originate in China and India, industry experts estimate, with China accounting for the lion's share." Reuters have been following scientists that are experimenting to determine the causes of elevated NDMA levels and identified China as a likely source of the initial blood pressure medication contamination. According to Reuters, "A common blood pressure and heart drug manufactured in bulk by a Chinese company and sold worldwide may have contained an impurity linked to cancer since 2012, European regulators said. The revelation that the problem likely dates back to changes in manufacturing processes at Zhejiang Huahai Pharmaceutical six years ago suggests many patients could potentially have been exposed to cancer risk."

Finding the reasons for and the source of NDMA contamination remains a priority for Sanofi, the maker of Zantac. The company has forfeited billions of dollars in revenue when they voluntarily recalled Zantac, the world's best-selling heartburn and acid reflux medicine. The company complied with a citizen's petition made to the FDA by online testing pharmacy Valisure. Valisure found levels of NDMA thousands of times greater than the amount of 96 nanograms per tablet per day thought to be safe.

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OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. The Onder Law Firm has won more than $300 million in four talcum powder ovarian cancer lawsuits in St. Louis. Law firms throughout the nation often seek its experience and expertise on complex litigation.

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