The U.S. Food and Drug Administration conducts a voluntary recall of several drugs used to treat high blood pressure and heart conditions due to active ingredient valsartan.
The ingredient valsartan was found to have N-nitrosodimethylamine or NDMA, a substance that could cause cancer. The presence of the carcinogen was unforeseen and initial investigations suggested there were chemical reactions in the way these particular valsartan products had been manufactured.
FDA’s announcement was made a week after 22 other countries had conducted their respective recalls of valsartan. These recalls were made after a review from the European Medicines Agency or EMA had found that valsartan supplied by China-based company Zhejiang Huahai Pharmaceuticals contained NDMA.
FDA Issues Voluntary Recall
Not all medications containing valsartan were included in FDA’s recall. The board has recalled the valsartan made by Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries Ltd. The U.S. recall also included valsartan/hydrochlorothiazide sold by Solco Healthcare and Teva Pharmaceuticals Industries Ltd.
“[W]e’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,” explained Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research.
It was not immediately clear from FDA’s announcement whether these companies are in a way connected to Zhejiang Huahai Pharmaceuticals.
How Risky Is NDMA
Patients should still contact their health providers before deciding to stop ingesting medicine with valsartan. EMA previously said that patients may be given a different valsartan medicine or alternative product.
“[O]ur 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,” assured Scott Gottlieb, FDA commissioner.
The human carcinogen NDMA is an organic chemical that is also used to make liquid rocket fuel, softeners, and lubricants. This chemical may also be unintentionally produced during chemical reactions.
It is also a byproduct from pesticide manufacturing, or during the making of rubber tires or fish processing. Previous trials with animals showed NDMA can trigger the growth of tumors in the liver, kidney, and respiratory tract.
EMA said investigations are still ongoing with regard to the possible harmful effect on patients who have been taking the products in question. The agency is also looking for a strategy to reduce or eliminate the NDMA from subsequent valsartan products.
The countries that recalled valsartan ahead of the FDA are Germany, Finland, Norway, Sweden, Hungary, Austria, the Netherlands, Bulgaria, Ireland, Spain, Italy, Belgium, Portugal, France, Croatia, Poland, Greece, Lithuania, Canada, Herzegovina, Bosnia, Bahrain, and Malta.