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Another Recall Casts Doubt On Ranitidine Being Unstable

A type-2 diabetes drug is recalled in Britain, challenging the ranitidine only NDMA theory

Thursday, August 26, 2021 - It would be easy to assume that Zantac ranitidine itself was more unstable than other molecules and naturally deteriorated into NDMA, as is the opinion of online prescription drug testing pharmacy Valisure Inc. The problem is that every day it seems, a new study, evidence, or recall comes out that makes the ranitidine single bullet theory seem shaky. If ranitidine is the only substance to degrade due to high temperatures during storage or shelving of the product, that would be one thing. Other drugs like certain high blood pressure medicines, diabetes medicines, and most recently, anti-smoking aid Chantix were tested and contain dangerously high amounts of NDMA. Thousands of people have registered their intent to file a lawsuit with Zantac cancer attorneys, alleging that taking the drug every day for over a year caused them to develop cancer of the stomach, bladder, esophagus, colon, prostate, and other types of cancer. The exact reasons Zantac ranitidine has high levels of NDMA is still a mystery and could be caused by any number of reasons like faulty manufacturing processes in China and India where 85% of the ingredients that go into US drugs are processed. The judge in charge of the pretrial proceedings in the Zantac cancer multidistrict litigation has scheduled a science day in September to interview the best expert scientific witnesses from the plaintiffs and the defense. The judge could deliberate for six months or more before deciding on whose opinion is the most valid. The first Zantac cancer trials could begin in early 2023.

The debate to pin down the exact reason why Zantac ranitidine tablets developed an extraordinarily high level of N-nitrosodimethylamine (NDMA), a known carcinogen that could be responsible for causing heartburn medicine cancer, is getting more and more complicated. Yesterday, the Medicines and Healthcare products Regulatory Agency, Britain's medical watchdog, recalled a batch of popular medicine (metformin) that controls type-2 diabetes throwing even more shade over the prevailing Zantac ranitidine cancer theory. More than 20 million people in Europe use metformin daily to help regulate their blood sugar levels. Diabetic patients should continue to take their necessary diabetes medicine and contact their doctor immediately.

On September 9, 2019, Valisure petitioned the US Food and Drug Administration (FDA) to recall ranitidine saying that it had found more than 3 million nanograms of NDMA per tablet of ranitidine it tested. The FDA tests during the next month failed to confirm the high NDMA levels, but the FDA issued the recall out of an abundance of caution. Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research made the following official statement: "We didn't observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don't know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured."

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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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