The Miami Herald reported the Food and Drug Administration “issued a voluntary recall of several medications that contain the active ingredient valsartan, which is used to treat high blood pressure and heart failure.” The agency said in a statement, “This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled.” Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, said, “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.”

The Atlanta Journal-Constitution reported that NDMA “is an organic chemical that is often used in rocket fuel, softeners and lubricants,” and “is a known cancer risk.” The article adds that people “exposed to high levels of NDMA can experience liver damage that could result in cancer, according to the US Department of Health and Human Services.”

CNN reported on its website that FDA Commissioner Scott Gottlieb said, “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.” Gottlieb added, “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.”

Also covering the story are Healio Cardiology Today and Medscape.

From the news release of the American Association for Justice.