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The FDA Is Forcing Some Diabetic Drug Manufacturers to Pull Their Type 2 Products From Store Shelves

Like Zantac before it, diabetic drugs may contain elevated levels of NDMA a cancer-inducing substance

Monday, June 1, 2020 - The US Food and Drug Administration (FDA) has demanded that five US drug companies recall their diabetes drugs because they may contain a chemical that can cause cancer like the situation currently happening with anti-heartburn drug Zantac and other acid reflux medications. Zantac has been alleged by hundreds of people who have hired a Zantac Stomach Cancer Lawyer , of causing a wide variety of gastro-intestinal cancers. Metformin is sold under the brand name Glucophage and other brands and is used to treat type 2 diabetes in obese patients. In the United States, around 35 million have diabetes and many types 2 diabetic sufferers take metformin to reduce excess blood sugar out of the body through the urine rather than inject themselves daily with insulin.

The FDA is engaged in a delicate balancing act in regulating metformin because unlike heartburn drug Zantac, discontinuing taking their diabetes mediation without express directions from a physician could have life-threatening consequences greater than the consequences of continuing to take the drug. The FDA insists that patients should continue to take metformin but immediately consult their physician for guidance. Government regulators are also concerned that recalling all of the drugs at once could create shortages and put lives at risk by not being able to buy the drug.

The Independent reports that "Several batches of metformin, which is widely used to reduce excess blood sugar in type 2 diabetes patients, tested positive for unsafe levels of N-Nitrosodimethylamine (NDMA) the FDA said." NDMA is a known carcinogen that the US government health agency knew was contained in certain heartburn drugs at levels that were thought to be safe, however, certain environmental changes or contamination at overseas manufacturing plants could have led to the amounts escalating causing grave concerns. It is believed that NDMA increases with increases in the storage temperature of the drug and also when the chemical interacts with nitrites, a meat preservative found in hot dogs and other processed meats, within the stomach. More recently it is suspected that a failure in quality control at overseas drug capsule manufacturing plants like those in China could be responsible for the NDMA surge.

The FDA is seemingly caught between a rock and a hard spot on the metformin recalls as, on the one hand, the health agency wants to make sure that the drugs under their auspices are safe and pure for human consumption, but on the other hand, recklessly forcing a total recall could create a public health crisis. The Independent puts the situation this way. "The FDA is responsible for ensuring that medicines for the U.S. market are made in safe, sanitary conditions that meet federal quality standards. But government inspectors have repeatedly criticized the agency for falling short in reviewing overseas manufacturing plants as the pharmaceutical supply chain has increasingly spread to Asia."

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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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