The US FDA recalled certain medications that contain the drug Valsartan due to a possible cancer risk.
Valsartan is a drug that controls blood pressure and helps prevent heart failure.
The recall is due to the presence of the impurity, N-nitrosodimethylamine (NDMA). NDMA is an organic chemical that is in a family of potent carcinogens. It is an ingredient in liquid rocket fuel, softener, lubricants, and other products. It is also a byproduct from rubber tire and some pesticide manufacturing.
Animal studies show that NDMA can be toxic and cause tumors in the liver, kidney and respiratory tract. Exposure to high levels can cause liver damage and is a probable human carcinogen, according to the US EPA.
Valsartan is off-patent and a component of other generic medicines. However, the FDA said that it won’t recall all medicines that contain the drug. The US recall includes the versions of Major Pharmaceuticals made valsartan, Solco Healthcare and Teva Pharmaceuticals Industries as well as valsartan/hydrochlorothiazide sold by Solco Healthcare and Teva Pharmaceuticals Industries.
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that valsartan… does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
A Deeper Dive
In Europe and Asia, Novartis, the company that originally developed the drug, said that they recalled Sandoz valsartan and valsartan/HCT film-coated tablets because they “do not meet our high-quality standards.” Novartis spokesman Eric Althoff said that the recall did not affect products sold in the US. However, the FDA’s ongoing review and laboratory tests found otherwise. The FDA said that “the presence of NDMA was unexpected” and relates to changes in the way the manufacturer made the active substance.
“The amounts of NDMA found in Valsartan API are much lower than the cumulative endogenous production and usual external exposure of NDMA,” Althoff wrote in an email July 6. “There is no certainty as to how much this contaminant may potentially increase cancer risk in humans. Thus, the amount of NDMA found in the Valsartan API would not represent a significantly increased risk to the patients taking of Sandoz Valsartan and Sandoz Valsartan HCT Film coated tablets.”
“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 the manufacturer makes them].” Commissioner Dr. Scott Gottlieb said Friday. “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 [remove] the products from the market. As we seek [to remove] certain drug products today, our drug shortages team is also working hard to ensure [we meet] patients’ therapeutic needs… in the United States with an adequate supply of unaffected medications.” The FDA will continue its investigation into the drug.
If you are taking any valsartan-containing medications, please talk with your doctor as soon as possible.
Please note that you should not discontinue taking any medication without your doctor’s permission. Going off your medication without supervision could be dangerous, according to the American Heart Association (AHA).