FDA Recalls Blood Pressure, Heart Failure Medications
The U.S. Food and Drug Administration said it is recalling blood pressure and heart failure medications after cancer-causing agents were discovered.
The drugs might contain the ingredient valsartan, which is used to treat high blood pressure and heart failure, the FDA said. But an impurity in valsartan called N-nitrosodimethylamine (NDMA) was discovered, which is classified as a probable human carcinogen, which can cause cancer.
“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 in a statement.
He 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.”
The firms recalling products include Major Pharmaceuticals’ Valsartan, Solco Healthcare’s Valsartan and Valsartan/Hydrochlorothiazide (HCTZ), and Teva Pharmaceuticals Industries’ Valsartan and Valsartan/Hydrochlorothiazide (HCTZ).
“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, director of the FDA’s Center for Drug Evaluation and Research.