A common drug used to treat certain heart conditions is being recalled by the U.S. Food and Drug Administration because the drug contains a chemical that poses a potential cancer threat, according to a statement released on July 13.
The FDA said the recall affects several drugs products containing the active ingredient valsartan following the detection of an impurity found in the products. Valsartan is used to treat high blood pressure and heart failure. However, not all medication containing the ingredient is affected by the recall.
The impurity—an organic chemical called N-nitrosodimethylamine (NDMA)—was found in the recalled products. NDMA is classified as a probable human carcinogen based on results from laboratory tests. The chemical was previously used in liquid rocket fuel, antioxidants, additives for lubricants, and softeners for copolymers, according to the U.S. Environmental Protection Agency.
The U.S. recall includes drug products containing a version of valsartan made by Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries Ltd. Drug products containing valsartan/hydrochlorothiazide (HCTZ) made by Solco Healthcare and Teva Pharmaceuticals Industries Ltd. are also on the recall list.
“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.
The FDA announcement was made just a week after pharmacies from 22 countries pulled similar affected products from their shelves, reported CNN. The drugs involved in the recall outside the United States were produced by other pharmaceutical companies. UK pharmacies have been advised to recall valsartan-containing drugs made by Dexcel Pharma Ltd and Accord Healthcare, while the European Medicines Agency is investigating drug products supplied by Zhejiang Huahai Pharmaceuticals; a company in Linhai, China.
The recall in other countries was initially thought to not affect products sold in the United States but ongoing FDA review and tests found otherwise, reported CBS.
According to the FDA, the discovery of NDMA in drug products was said to be “related to changes in the way the active substance was manufactured.”
The agency said the review into drugs contamination is ongoing, with a focus to investigate levels of NDMA in the recalled products, assess the possible effect on patients who have been taking them, and determine what measures can be taken to reduce or eliminate the impurity from future batches produced by the companies.
According to the U.S. Department of Health and Human Services, animal experiments have shown that exposure to NDMA could potentially cause tumors in the liver, respiratory tract, kidney, and blood vessels.
“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.
“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 FDA is advising patients who are taking the recalled valsartan-containing medicines to continue taking their medicine until they have a replacement product.
Patients should look at the drug name and company name on the label of their prescription bottle to determine whether their medicine is part of the recall. If a patient is taking one of the recalled medicines listed below, they should follow the recall instructions provided by the specific company available on the FDA’s website.
The FDA also advises patients to contact their healthcare professional if their medicine is included in the recall to discuss their treatment options.