Recent class action lawsuits and investigations allege that valsartan, a blood pressure drug meant to treat hypertension, may cause liver damage or cancer due to a lack of quality control at its production site factory.

According to a report released in May 2018 by the European Medicines Agency (EMA), medicines from the company in China are being examined and tested for impurities including carcinogens. FDA inspections of several factories in China and India have discovered that multiple blood pressure medications including valsartan may have been affected by these impurities.

Risks of Contaminated Valsartan

Tainted valsartan may have serious health implications for patients, including liver damage and cancer. Signs and symptoms that have been reported include jaundice, abdominal pain, nausea, skin changes, and hepatomegaly, or enlargement of the liver. The FDA’s review of possible side effects from these medications is incomplete and ongoing. The lawsuits and investigations into the valsartan impurities include allegations that workers at the Zhejiang Huahai Pharmaceuticals factory consistently failed to investigate or report anomalies in their drugs. According to an investigative report by USA Today, initial reports of carcinogens in the drugs were inadequately investigated, and abnormalities in the pills often went unreported. Additionally, investigators at the factory discovered that many of the machines used in drug production had fraying gaskets, missing pieces, and rusty screws.Some of the impurities could cause cancer. The FDA has announced that nitrosodimethylamine, or NDMA, as well as nitrosodiethylamine, or NDEA have been discovered in batches of valsartan. NDMA and NDEA are classified as probable human carcinogens, or substances that are likely to cause cancer in people.Due to these alarming discoveries, a voluntary recall has been issued for valsartan.

What is Valsartan and Who is at Risk?

Valsartan is a drug meant for the treatment of high blood pressure and heart failure. It’s part of a class of drugs called angiotensin II receptor blockers, or ARBs. These drugs work by blocking a hormone that narrows blood vessels. According to the FDA’s press announcement regarding the valsartan recall, patients who are taking valsartan should not stop taking their medications until they speak to their doctor and find a replacement medication. Discontinuing valsartan without medical advice could be harmful.Patients are encouraged to look at the drug name and company name on their medication bottle and check the information against the FDA’s list of recalled valsartan drugs. It is unclear how many people may be affected by the valsartan recall, but according to the American College of Cardiology and the American Heart Institute, as of 2017 about 103 million adults in the U.S. had high blood pressure.If you have been prescribed valsartan for high blood pressure or heart failure treatment and are concerned that you may be suffering side effects from tainted medication, you may be eligible to join a valsartan investigation or lawsuit at no cost to you.