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Valsartan Voluntarily Recalled by the FDA Over NDMA Impurity

Jul 19, 2018

The U.S. Food and Drug Administration (FDA) recently announced a voluntary recall of drugs that contain valsartan, an active ingredient in a number of products meant to treat heart failure and high blood pressure.

While not all products containing valsartan were recalled, those with the impurity N-nitrosodimethylamine (NDMA) were included in the list. According to reports, the recall includes valsartan/hydrochlorothiazide (HCTZ), which is sold by Teva Pharmaceuticals Industries Ltd. and Solco Healthcare, as well as versions of valsartan produced by Teva Pharmaceuticals Industries Ltd., Solco Healthcare, and Major Pharmaceuticals.

According to the FDA, the presence of this probable human carcinogen is unexpected, and is believed to be caused by how these drugs were manufactured. The FDA announced that it is reviewing this discovery and is investigating the NDMA levels in each recalled product, the potential effects it could have on patients who took the recalled products, and what can be done to prevent this issue from occurring again in the future.

“The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” said FDA Commissioner Scott Gottlieb, M.D. “When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market. As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”

What is NDMA?

NDMA is a type of semi-volatile organic chemical that is present in very low levels in certain types of food, mostly in cured, smoked, or cooked meats. It can also be produced as a by-product in a number of industrial processes, and can be toxic to organs in great enough doses, most notably in the liver – it has been known to cause liver tumors, scarring, and liver fibrosis when tested on rats – and is a known human carcinogen.

NDMA is only intentionally produced in its pure form for research purposes. It used to be used in the production of a number of products, including copolymers softeners, lubricant additives, antioxidants, and liquid rocket fuel.

In the United States, it is classified as an extremely hazardous substance, and has even been used to intentionally poison people. The first reported case of NDMA being used as a poison occurred in 1978, when a teacher in Germany attempted to murder his wife by feeding her with jam laced with this chemical. He was sentenced to life in prison for his actions. That same year, an American man killed two people, a 30-year-old man and an 11-month-old child in Omaha, NE by spiking lemonade with NDMA. He was sentenced to death for his actions.

A key concern about NDMA is its solubility in water, and the fact that it has little to no odor or taste. It can be incredibly harmful at incredibly low levels of concentration that are difficult to detect, and is incredibly difficult to remove it from water it contaminates. Due to its composition, it cannot be removed by activated carbon, a common substance used to purify contaminated water.

This recall comes just one week after 22 countries across the globe issued recalls due to the potential cancer risk. Due to the severity of the conditions these drugs are used to treat, the FDA stated that patients taking these drugs should continue to do so until a replacement product is provided. However, patients taking any valsartan-containing medicine should contact their health care professional to determine whether or not their treatment is affected by the recall and if there is an alternative option available.

“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

Our Houston personal injury attorneys at Bailey Peavy Bailey Cowan Heckaman have dedicated their careers to providing injured victims with the knowledgeable and experienced legal representation they require. If you were seriously affected by defective drugs or tainted medication, give us a call at (888) 367-7160 to discuss your situation over the phone, or send us the details of your case through our online form today to set up a free case evaluation with a member of our firm. We understand just how devastating these situations can be to you and your entire family, and our attorneys are committed to fighting for and securing the compensation you deserve.

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