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Alternative FDA Testing Methods Did Not Find Zantac To Be Dangerous

Heating ranitidine to high temperature during Valisure's testing may have produced false NDMA readings according to the US Food and Drug Administration

Thursday, August 6, 2020 - People are asking the question, "What testing methods does online drug testing pharmacy Valisure use, and can they be trusted to produce accurate results?" Ever since revelations started surfacing that the new and untested online drug testing pharmacy found Zantac to have levels of NDMA, millions of Americans have become concerned that they may have been exposed to the cancer-causing chemical. Thousands of individual cancer sufferers have hired Zantac Cancer Lawyers and filed claims against Sanofi, the maker of Zantac. The company will be forced to defend itself from accusations of failing to warn consumers of what they knew or should have known about Zantac containing higher than normal levels of the carcinogen. Sanofi's defense claims that Valisure's testing methods caused NDMA to increase in Zantac and other blood pressure and diabetic medications.

Valisure points potential clients and investors to the fact that their scientists hold ivy-league credentials, and that their testing methods include the latest laser technology as well as using FDA testing standards. Their service fills a void, that, in general, most drugs consumed in the US are generics and that around 80% of generics are manufactured under potentially sub-standard conditions in China and India where quality-control testing may be non-existent. That makes perfect sense. The company also stresses that a patient's doctor has no idea whether or not the drug he/she has just prescribed is what the doctor thinks it is or whether or not it has gone bad. The company was invented when one of the founders had a life-threatening adverse reaction to a drug he was prescribed. Valisure's statement goes like this: "About 80% of ingredients in U.S. medications are manufactured in India or China where FDA oversight is difficult. Also, roughly 90% of drugs Americans take are generic, and in the U.S. there are approximately three drug recalls a day. Focus on quality and consistency has become an increasingly important concern for the public and is an issue that only Valisure addresses directly to consumers."

The FDA has set 96 nanograms as the acceptable limit to the amount of NDMA that a drug tablet may contain. Valisure allegedly found higher than acceptable levels in every single sample that they tested. The unanimous findings make one question the efficacy of the tests themselves. The problem is that Valisure's testing methods may be responsible for the increase in NDMA. According to Scientific American, "the agency (the FDA) recommends using one of two techniques: liquid chromatography-high-resolution mass spectrometry (LC-HRMS) or liquid chromatography-tandem mass spectrometry (LC-MS). Employing LC-HRMS, the FDA found much-lower NDMA levels than Valisure had reported."

There can be little doubt that heating ranitidine to high temperatures can cause carcinogenic levels of NDMA to develop. Plaintiffs suing Sanofi have hope that juries find that the company had an obligation to know and to warn consumers of this fact.

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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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