Patients taking angiotensin receptor blockers (ARBs) like valsartan and Losartan rely on the drugs prescribed to them for safe, healthy lives, and when the drugs stop being safe, the consequences can be devastating. For example, due to the unexpected presence of the contaminants N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) in certain batches of valsartan and Losartan manufactured in China and India, patients taking the hypertension medication could be at risk for stomach cancer, colorectal cancer, kidney cancer, liver damage, tumors and liver cancer. If you believe you have been adversely affected by side effects of the blood pressure medication valsartan or losartan, please complete the online form on this page or call now. You may have grounds to file a valsartan or losartan lawsuit against the companies found at fault for the NDMA and NDEA contamination, in order to pursue financial compensation for your injuries, medical expenses, pain and suffering, and other losses.
Several pharmaceutical companies have voluntarily recalled their medications containing valsartan and losartan after it was discovered that the drug may have been tainted with the carcinogen NDMA or NDEA during the manufacturing process. According to reports, certain batches of valsartan manufactured by both Zhejiang Huahai Pharmaceuticals in China and Hetero Labs Limited in India may have become tainted by NDMA. Formerly used in the production of liquid rocket fuel, softeners for copolymers and additives for lubricants, the Environmental Protection Agency (EPA) reports that NDMA is now only produced in pure form for research purposes. The safety of drugs imported from other countries has long been disputed, and the FDA has announced that it will continue to investigate the levels of NDMA contamination in the recalled valsartan products to determine how to eliminate the impurity from future batches of the drug. Says Dr. Harry Lever, a cardiologist at the Cleveland Clinic in Ohio, “It’s not just valsartan. It’s becoming very difficult for me to write prescriptions at all. There are so many drugs that are coming in from India and China and companies are buying and selling each other and you don’t know what’s what.”
By lowering blood pressure, sartan drugs can reduce the risk of heart attacks and strokes, but when it contains an impurity like NDMA or NDEA, it can put patients at seriously increased risk for liver cancer, kidney cancer, stomach/gastric cancer, colorectal cancer, liver damage and other serious side effects.
Valsartan, the generic version of the brand-name drug Diovan, is a medication commonly used to treat high blood pressure (hypertension) and heart failure. It can also be used to lower the risk of death after a heart attack. Valsartan is an angiotensin-II receptor antagonist and it works by blocking a substance in the body that causes blood vessels to constrict, thereby lowering blood pressure and allowing an increased supply of oxygen to reach the heart. High blood pressure is a common condition affecting one in four American adults, but few people realize that prolonged hypertension can result in potentially life-threatening medical problems. If high blood pressure continues for a long period of time, the heart and arteries may not be able to function properly, and this can damage blood vessels in the heart, brain and kidneys, possibly resulting in heart failure, stroke or kidney failure. By lowering blood pressure, valsartan can reduce the risk of heart attacks and strokes, but when it contains an impurity like NDMA, it can put patients at risk for liver damage and other serious side effects.
Patients taking recalled valsartan medications contaminated with NDMA may be able to seek financial compensation for:
Valsartan lawsuits allege that the blood pressure medication can be contaminated with a substance called N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen, meaning exposure to it can cause cancer. In May 2018, the European Medicines Agency began reviewing valsartan-containing medications supplied by the Chinese company Zhejiang Huahai Pharmaceuticals, after NMDA was detected in the valsartan it was supplying to manufacturers in the European Union. In July 2018, the FDA announced that three companies were voluntarily recalling their valsartan medications supplied by Zhejiang Huahai Pharmaceuticals, after detecting the presence of NDMA in the medications. It is believed that the NDMA contamination in question could have begun as early as 2012, when Zhejiang Huahai Pharmaceuticals changed its manufacturing process.
In August 2018, the FDA announced a recall of certain batches of valsartan produced by India-based company Hetero Labs Limited, due to the presence of NDMA, and Torrent Pharmaceuticals also announced the recall of 14 lots of Valsartan/Amlodipine/HCTZ tablets due to NDMA contamination. The FDA action came after 22 other countries recalled 2,300 batches of valsartan supplied to Germany, Finland, Sweden, Norway, Ireland, Hungary, the Netherlands, Austria, Bulgaria, Spain, Belgium, Bosnia, Canada, Greece, Poland, Croatia, Italy, Portugal, France, Lithuania, and Herzegovina, Bahrain and Malta. In the aftermath of the valsartan recall, attorneys across the country are investigating claims on behalf of patients who suffered serious health consequences as a result of taking valsartan contaminated by NDMA.
Valsartan recall: 4 things patients should know (CNN)
Analysis of NDMA levels in recalled valsartan in the U.S. (American Pharmacists Association)
Update on review of recalled valsartan medicines (EU Medicines Agency)
FDA expands recall of heart drug for possible cancer-causing contamination (USA Today)
