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The FDA Requires That Drug Companies Regularly Test Ranitidine And Other Drug For NDMA

NDMA has been found in another medicine and Pfizer has voluntarily recalled the drug

Thursday, March 24, 2022 - More than 125,000 heartburn medicine cancer lawsuits have been registered alleging that ranitidine is unstable and causes cancer. The US Food And Drug Administration (FDA) issued a recall of Zantac ranitidine exercising an abundance of caution over the compound degrading into a carcinogen when overheated. Online prescription drug testing pharmacy Valisure tested ranitidine and found it contained highly elevated levels of N-nitrosodimethylamine (NDMA) a known carcinogen manufactured and given to experimental test animals to invoke cancer tumors for study. According to The National Institute of Health (NIH) "N-nitrosodimethylamine (NDMA) is a hepatotoxic agent and carcinogen contaminant in commonly used medications such as valsartan, losartan, irbesartan, and ranitidine." Valisure discovered that the ranitidine molecule was inherently unstable and broke down naturally to become N-nitrosodimethylamine (NDMA), a carcinogen known to cause cancer in humans. The FDA's April 1, 2020 recall required Zantac to be taken off the market and that all manufacturers of ranitidine immediately randomly test their shelved ranitidine products for the presence of (NDMA), and to pull the product if it tested positive for more than 96 nanograms per dosage, the FDA's acceptable limit for human ranitidine exposure. In addition, the FDA demanded companies test all products, not only ranitidine for unacceptable levels of NDMA, not only heartburn and acid reflux medicines.

Previously, some blood pressure and diabetes medications also tested positive for unacceptable levels of NDMA and were recalled. The other day, Pfizer voluntarily recalled ts blood pressure drug Accuretic from the market after failing the required NDMA testing. It is important to note that it is the frequency and cumulative effect of ingesting NDMA that is at issue. NDMA is in hot dogs, bacon, and all cured, processed meats at levels many times more than the 96 nanograms FDA limit. What makes medicine NDMA levels so strict is the frequency with which medicine is taken. People are advised to avoid eating processed meats and limit them to one serving per week or less. Blood pressure, diabetes, and heartburn relief medicines may be taken daily or several times per day. Pfizer recently d Chantix smoking cessation medicine over fears of excessive NDMA levels. The New York Times released a statement from Valisure CEO David Light commenting on the Pfizer/Accuretic recall. "On Wednesday, David Light, a founder of Valisure, said: "We're now over three years after the initial discoveries of nitrosamine impurities in major medications and continuing to see the ripple effects grow," the Times reported. Mr. Light may be a star witness in bellwether Zantac cancer lawsuits beginning next year. Valisure's ranitidine testing methods have come under scrutiny from Sanofi and Glaxo Smith Kline defense attorneys who think the company distorted test results by overheating ranitidine samples to cause the NDMA spike. Glaxo has implied that Valisure may have deliberately exaggerated the NDMA panic to draw attention to their fledgling online startup company.

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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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