Since July 2018, there have been dozens of recalls of hypertension medications containing the drug, valsartan, and just a couple of weeks ago, AurobindoPharma USA, Inc. and Acetris Health LLC issued its own voluntary recall for 39 lots of valsartan products.
The reason for all of these recalls is that the high blood pressure medications may contain a contaminant known as N-nitrosodimethylamine (NDMA), which is classified as a “likely human carcinogen” (cancer-causing substance). NDMA was found in multiple batches of valsartan tables manufactured by a number of different drug makers. If you or a loved one has taken drugs containing valsartan and have been diagnosed with cancer, you may have cause to file a product liability lawsuit.
Used to treat high blood pressure, valsartan is an angiotensin receptor blocker (ARB), designed to relax blood vessels, which aids in creating an unobstructed flow of blood. In addition to being used to treat high blood pressure, it is also prescribed to reduce the risks for heart attack, stroke, and kidney failure. Valsartan is sold under many brand names including Diovan, Prexxartan, Valturna, and Entresto.
Valsartan is not considered a dangerous medication when free of contaminants, and it produces only mild side effects when taken correctly including light-headedness, muscle weakness, irregular heartbeat, and fainting in some people. However, there is evidence that many valsartan products manufactured since 2014 have been contaminated with NDMA, and as such, hundreds of thousands of people may be at risk for developing serious health issues including cancer.
FDA Recall List
The Food and Drug Administration (FDA) is reviewing and investigating the levels of NDMA found in medications containing valsartan. In addition, the agency will be investigating and assessing possible effects on patients who have taken the drugs. The FDA is also said to be looking for possible changes to the manufacturing process that will reduce or eliminate the impurity from future batches of hypertensive medication.
The FDA has emphasized that patients should not stop taking drugs containing valsartan without first speaking to their prescribing physician. The danger of abruptly discontinuing use of this medication greatly outweighs the risks associated with short-term NDMA exposure. Anyone taking valsartan-containing hypertensive medication should contact their healthcare provider right away to discuss alternative medication options.
The FDA has published a comprehensive list of all valsartan-containing products that have been recalled. These valsartan-containing products have not been recalled.
The FDA advises consumers to call 1-800-505-9291 Monday through Friday between 9:00 a.m. and 5:00 p.m. CST or email [email protected] with any questions. If you have been harmed by a dangerous drug or some other recalled defective product, please contact an experienced defective product attorney in your area to schedule a free consultation.