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Sanofi May Have Known For Years That Zantac Could Cause Cancer

The company pocket billions in profits and may have ignored their responsibility for public health safety

Monday, October 5, 2020 - Zantac cancer first caught the attention of the mainstream media and the public on April 1, 2020, when the U.S. Food and Drug Administration (FDA) officially requested all companies selling ranitidine (Zantac and other lesser-known brands) remove the product from the market. The request was not made out of an abundance of caution, but rather because highly-elevated levels of N-Nitrosodimethylamine (NDMA) were found and reported to the FDA by online testing pharmacy Valisure. Previously, the World Health Organization had labeled NDMA as probably carcinogenic. Europe followed the lead of the US FDA and also recommended that companies stopped selling Zantac (ranitidine). Korea had banned ranitidine back in September 2019.

In 2016, the FDA recognized that ranitidine contained NDMA, and also that NDMA was carcinogenic. The public health agency set a limit of 96 nanograms (ng) per tablet as an acceptable level. Valisure found levels of NDMA many thousands of times greater creating a near panic and the ranitidine market withdrawal. The FDA announced: "Low levels of NDMA are commonly ingested in the diet, for example, NDMA is present in foods and in water. These low levels would not be expected to lead to an increase in the risk of cancer. However, sustained higher levels of exposure may increase the risk of cancer in humans." Zantac cancer attorneys offer a free consultation with no obligation to file a lawsuit claim.

Legal experts are critical of FDA taking four years to conclude ranitidine cancer and are asking why Sanofi never disclosed what they knew NDMA potential to cause Zantac cancer. The FDA wrote on its website in 2020, "The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S." Sanofi, the maker of Zantac, is also under federal investigation for allegedly covering up what they knew about Zantac cancer. Sanofi disclosed the investigation's demands in a filing required by the Securities and Exchange Commission (SEC) in July 2020, reporting, "The U.S. Justice Department launched an investigation into whether Sanofi and GlaxoSmithKline failed to report information about a potential carcinogen to the federal government. (Sanofi) ... received civil investigative demands from the Justice Department seeking information on NDMA, an organic chemical used in versions of the common heartburn drug ranitidine, also known by the brand name as Zantac." The article also describes NDMA as being a byproduct of rocket fuel production and that NDMA can "significantly increase" if stored at high temperatures.

Over 15 million Americans were regularly taking Zantac at the time of the recall. Sanofi profited billions every year from the sale of the heartburn and acid reflux medication, yet never bothered to mention what they knew of the potential cancer risks. Thousands of Americans with cancer have filed lawsuits charging Sanofi of failing to disclose what they knew or had an obligation to know about the drug's cancer connection.

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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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