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The FDA Did Not Follow-Up Test Zantac Until Too Late

The US Food and Drug Administration (FDA) got it very wrong back in 1999 when they approved Zantac and declared the medicine safe

Monday, January 25, 2021 - Heartburn sufferers got a double dose of bad health news in the first part of 2020 when the coronavirus struck, and Zantac was unavailable. On April 1, 2020, Zantac users found out that they could no longer get the medicine because it was suspected of causing cancer. The Food and Drug Administration had recalled all forms of ranitidine, of which Zantac is the most popular and best-selling brand. It was theorized that NDMA in Zantac could cause a variety of types of cancer that range from stomach cancer being the most common to the bladder, colon, and even breast cancer. Over 500 lawsuits have been filed, and thousands more are expected in the months to come, against Sanofi, the maker of Zantac. The company profited billions in revenue from the sale of Zantac for two decades. Sanofi is under Federal investigation for lying to government regulators about their knowledge of Zantac's NDMA cancer connection. Zantac cancer attorneys are helping thousands of families and individuals suffering from side effects such as stomach and other cancers linked to taking Zantac heartburn medication.

To make matters worse, Zantac users naturally assumed that the drug was safe and thoroughly tested by the FDA. It has recently come to light that it may not have been. Zantac Tablets (ranitidine hydrochloride), manufactured and marketed by Glaxo Wellcome Research and Development, was approved by the FDA on October 29, 1999. Zantac (ranitidine) FDA approval may have circumvented the FDA's strictest approval process and brought it to market by meeting the criteria of being substantially like some other drug already on the market. It is assumed that the FDA tested the drug for NDMA levels and because the agency established a threshold of 96 NGS as being safe.

Physician prescribing and patients taking Zantac are responsible for contacting the FDA online to complain about the drug's potential side effects. All was quiet about Zantac for more than a decade until elevated levels of NDMA, a known carcinogenic compound, was discovered by an independent online pharmaceutical testing service and reported to the FDA. A recent query of the FDA's ranitidine complaint database indicates that H2 antagonist heartburn drugs like Zantac are more than twice as likely to cause cancer than protein pump inhibitor drugs like Prilosec.

At the core of Zantac's difficulties are patient complaints that taking the drug regularly and for years caused one to develop cancer of the stomach, bladder, colon, and a host of other cancer. The FDA knew back in 1999 that Zantac was contaminated with NDMA but assumed the level to be below an amount suspected to cause cancer. Scientists now think ranitidine to be inherently unstable and naturally breaks down to become carcinogenic.

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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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