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Finding Cancer Causing Chemicals in Heartburn Drugs Like Zantac May Be Only The Beginning

The CEO of the testing company that found elevated levels of NDMA in Zantac now thinks that the entire overseas drug supply chain may be in jeopardy

Wednesday, June 10, 2020 - Medical experts that have examined the situation surrounding the recalls of blood pressure, heartburn, and diabetic drugs are concerned that many other types of medications could also soon be required to voluntarily withdraw their medicines from the market leaving a gaping hole in global health care systems. It is also looking clear that the US Food and Drug Administration is incapable of performing inspections on the hundreds of different medications that they have approved for sale over several decades. The Coronavirus pandemic has also put stress on the agency that was formed to keep an eye on companies that manufacture drugs and to keep consumers safe. Most recently, the FDA caught up with the increases in cancer-causing NDMA in metformin diabetes medications and recommended that five of the leading drug companies pull the prescription medication from being offered in North America. Those companies are Apotex, Actavis, Amneal, Lupin, and Marksans. Zantac antacid cancer lawsuit attorneys are helping families and individuals nationwide that have suffered from Zantac antacid cancer and offer a free consultation.

At the forefront of testing and finding NDMA in various medications and the person at the center of causing concern for the future of the US drug supply chain is the David Light, CEO of online pharmaceutical testing company Valisure. According to Fierce (FP), Mr. Light testified recently to a US Senate Finance Committee that "The COVID-19 pandemic has exposed significant flaws in the FDA's ability to adequately inspect drugs produced by foreign manufacturers and might cause quality concerns in the U.S. supply for years to come." Light told Senators that the FDA's inability to accurately test drugs manufactured overseas and sold in the US could undercut consumer's confidence in the agency. According to FP, " Light warned senators that the combination of a strained global supply chain and structural issues in the FDA's testing of foreign drugs could damage consumer confidence." Light's company, Valisure, was at the epicenter of finding alarmingly increased levels of N-Nitrosodimethylamine (NDMA), a chemical that is naturally occurring but is thought to be capable of causing cancer if taken in large enough quantities, in Zantac, the world's best-selling heartburn and acid reflux medication. Valisure immediately alerted the FDA and Zantac's maker Sanofi, which voluntarily recalled the product immediately to be tested further. It is thought that higher storage temperatures for the tablets could cause increases in NDMA as could the chemical's interaction with nitrates from food in the stomach. Nitrate is a common preservative found in processed foods and meats.

Light's Senate testimony focused on suspicions that NDMA contamination could affect many other drugs in the months to com that are manufactured abroad because the current pandemic was making it impossible for the FDA to do its job. Fierce Pharma points out that before the pandemic hit in early March, the FDA contended that metformin did not have elevated levels of NDMA, an opinion the agency quickly reverses when it received a citizen's petition containing Valisure's testing results. Fierce Pharma wrote: " Valisure testing discovered problems in 42% of the batches it checked. It contends the situation is likely to get worse as the COVID-19 outbreaks wreak havoc on supply chains."

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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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