FDA Recalls Blood Pressure Drug Valsartan Over Cancer Risk
Valsartan was recalled by the FDA after studies showed that the blood pressure medication was contaminated with a chemical that causes cancer.
Patients who used Valsartan and were diagnosed with cancer may be eligible to file a lawsuit.
➢ What is Valsartan?
Valsartan is part of a class of prescription medications known as angiotensin II receptor antagonists, or angiotensin-receptor blockers (ARBs). These medications work by blocking the activity of natural substances in the body that tighten the blood vessels. Blocking the activity of these substances allows blood to flow more smoothly and the heart to pump more efficiently.
Valsartan is most commonly prescribed to patients with high blood pressure. The drug is also commonly given to patients with congestive heart failure, or to increase the survival rate among patients who have recently suffered a heart attack.
➢ Why was Valsartan recalled by the FDA?
In 2018, the FDA announced that it was recalling Valsartan after tests showed that the drug was contaminated with a chemical that could increase the risk of cancer. This chemical, known as N-nitrosodimethylamine (NDMA), was originally used to manufacture rocket fuel.
Further investigations revealed that some Valsartan medications were contaminated with NDMA from 2012 through 2018. Patients who used Valsartan during this period may have been repeatedly exposed to NDMA, putting them at an increased cancer risk.
During the following year, the FDA expanded the list of Valsartan medications that were found to be contaminated with NDMA. Several companies that manufacturer Valsartan have also announced their own recalls of the drug over concerns that patients who were prescribed the blood pressure drug may be in danger of a cancer diagnosis.
➢ What types of cancers have been linked to Valsartan?
Tests on laboratory animals have shown that NDMA – the contaminant found in Valsartan – is highly carcinogenic. Researchers at the World Health Organization (WHO) has declared that NDMA is “probably carcinogenic to humans.”
According to the WHO, exposure to NDMA is most highly associated with the following types of cancer:
- Colorectal cancer
- Gastric cancer
- Stomach cancer
However, because most available data on NDMA has only examined exposure to the chemical through drinking water, it is unclear if patients exposed to the chemical by taking Valsartan may face an increased risk of other serious or potentially deadly cancers.
➢ Have all formulations of Valsartan been recalled, or only certain manufacturers?
Following the FDA’s recall of Valsartan, several manufacturers also announced that they were recalling the blood pressure drug over concerns about its risk of causing cancer. Some of the manfacturers that have recalled Valsartan include Actavis, Aurobindo, Hetero/Camber, Macleods, Mylan, Teva Pharmaceuticals, and Torrent Pharmaceuticals.
The FDA has released a complete list of Valsartan medications and other ARBs that are known to be contaminated with NDMA. The complete list of recalled medications is available on the FDA’s website.
➢ Are lawsuits being filed over Valsartan cancer?
Several patients who were diagnosed with cancer after using Valsartan have filed lawsuits against the manufacturers of these drugs. In early 2019, several of these lawsuits were consolidated in a multi-district litigation (MDL) in New Jersey.
Because millions of Americans used Valsartan during the seven year period when the drug was contaminated with NDMA, there may be thousands of patients in the U.S. who developed cancer because they were exposed to this carcinogenic chemical. Legal experts have predicted that as many as 2,000 Valsartan lawsuits will be filed against the manufacturers of the blood pressure drug over the next two years.
➢ Do I qualify to file a Valsartan lawsuit?
If you were diagnosed with cancer after using Valsartan, you may be eligible to file a lawsuit and receive compensation. Our law firm is actively seeking to speak with Valsartan patients who were diagnosed with cancer in order to help them determine whether they may qualify to file a lawsuit.
For more information about filing a Valsartan lawsuit and to find out whether you may qualify to take legal action, contact the lawyers at Hissey, Mulderig & Friend for a free legal consultation. You can reach us by calling toll-free at 1-866-275-4454, or by filling out the free case evaluation form on the right side of this page so one of our representatives can contact you for more information about your case.