Azido Impurities May Taint Zantac During Manufacturing In India And Be As Deadly As NDMA
Swiss scientists are rethinking what causes drug impurities and Zantac cancer
Wednesday, October 27, 2021 - Researchers like those at Valisure online prescription drug testing pharmacy, think ranitidine is an inherently unstable molecule and naturally degrades into NDMA, while other scientists blame conditions at overseas drug manufacturing facilities in India and China that have relatively lax health regulations, for causing the impurities. Valisure is convinced that heating ranitidine above room temperature can cause the molecule to break down, while others, including the US Food and Drug Administration, cannot confirm Valisure's ranitidine assessment. People that have taken Zantac heartburn and acid reflux medicine have been diagnosed with heartburn medicine cancer and other life-threatening diseases. Former Zantac users have filed Zantac cancer lawsuits against Sanofi and Chevron for failing to warn them of the carcinogen that allegedly taints their medicine. More than 130,000 former Zantac users have registered their intent to file lawsuits against the makers of Zantac once bellwether trials slated for next year have concluded.
The FDA issued a recall of all ranitidine products out of an abundance of caution because they could not control or monitor conditions in the transportation or storage of ranitidine-based heartburn drugs. This time the impurity in medicine capsules may be more dangerous than finding elevated levels of N-nitrosdimethylamine (NDMA) in blood pressure, heartburn, diabetes, and smoking cessation medicines. In the course of examining Zantac for nitrosamines impurity, a Swiss medical research company thinks that the heartburn drug may also contain azido impurities. Azido impurities are mutagenic and could damage a person's healthy DNA and increase the risk of cancer.
It seems that Valisure may have overstepped as other medicine capsules, not only Zantac have been found to contain NDMA impurities and even worse. Valisure by their admission made alterations to the FDA's NDMA testing methods and significantly increased the temperature during testing. As suspected, drug impurities have been confirmed during the manufacturing process in China and India that researchers think leads to high NDMA and Azido levels. SwissInfo.ch reports " a U.S. Food and Drug Administration inspector has found at least one large manufacturer in India, Hetero Labs Ltd., has a flawed process for controlling the impurities, according to documents reviewed by Bloomberg. Hetero also has not adequately ensured a residue of impurities is not building up on production equipment, which can cross-contaminate subsequent batches, according to the documents." Swiss Info further explains that there are 10 drug manufacturing plants in Sangareddy India are registered with the US FDA to play a role in the manufacturing of drugs that eventually make their way to the US market. "was last inspected in 2018 and received the agency’s worst classification, which means it’s likely the company would have a hard time getting FDA approval to make any new drugs there until it clears up its issues. But the agency typically allows companies with long lists of violations stemming from inspections to continue to make drugs they’re already allowed to produce at substandard plants while they work on fixing their problems," Swiss Info confirmed.
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Lawyers for Zantac Heartburn Medicine Lawsuits
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.