A cardiovascular medication used to treat high blood pressure and heart failure is at the center of controversy over reports of contamination that may cause cancer.

Background of Valsartan

The generic equivalent to the brand-name drug Diovan, valsartan is a blood pressure medication that’s part of a class of hypertension drugs known as Angiotensin II receptor blockers.

The U.S. Food and Drug Administration (FDA) approved the medication to treat high blood pressure in adults and in children ages six and up. In adults, valsartan is also approved to treat heart failure, and to reduce the risk of death in patients recovering from a heart attack.

Generic valsartan is distributed by a number of manufacturers, including Major Pharmaceuticals, Teva Pharmaceuticals, and others.

Valsartan FDA Recall

In 2018, the valsartan FDA recall was announced following reports that the medication may contain a known carcinogen, according to USA Today. A China-based manufacturer disclosed that it had discovered an impurity, known as NDMA — a “probable human carcinogen”– in some of its valsartan batches.

Regulators believe the presence of NDMA may be the result of changes in the manufacturing process that were implemented in 2012. This news stoked fear in both officials and patients that NDMA may have been in valsartan for years.

The initial valsartan FDA recall was announced in July 2018, when the agency informed the public that it had asked manufacturers of generic valsartan to issue voluntary recalls for the medication, taking it off the U.S. market. Regulators in Europe and the U.K. announced similar recalls.

Pharmacists have also been asked to remove the medications affected by the valsartan FDA recall and return it to the manufacturers.

However, not all valsartan drugs have been affected by the recall. Manufacturers and repackagers involved in the recall include:

• Major Pharmaceuticals
• Solco Healthcare
• Teva Pharmaceuticals
• Bryant Ranch Prepack
• J Harkins Company
• Lake Erie Medical (d/b/a Quality Care Products)
• NuCare Pharmaceuticals
• Northwind Pharmaceuticals
• Proficient Rx

The FDA cautions valsartan patients not to stop taking the drug until they have consulted with their physician about finding a replacement treatment.

FDA’s Continuing Action

As part of its ongoing investigation into valsartan and other angiotensin II receptor blockers (ARBs) used to treat high blood pressure and heart failure, the FDA in May 2019 announced that it had confirmed the presence of two nitrosame impurities — Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) — in Angiotensin II receptor blockers (ARBs), including valsartan.

Citing an “unacceptable safety risk to patients,” the FDA determined that “the impurities may have been present in valsartan-containing finished drug lots for up to four years.”

In a news release, the Public Interest Research Group (PIRG) called for the FDA to step up the investigation.

“After 75 recalls it is clear more aggressive action is needed,” PIRG’s  Adam Garber said in a prepared statement. “Americans expect their blood pressure medication to treat their conditions, not cause cancer. The FDA needs to finish its investigation and develop a plan to prevent further contamination.”

The FDA has posted a list of a recalled valsartan products, along with the manufacturers and lot numbers. The list also notes if the product was tested for either contaminant.

Filing a Valsartan Lawsuit

If you or someone you love has suffered from cancer or liver damage after taking valsartan, you may be able to pursue litigation. Filing a lawsuit cannot take away the pain and suffering caused by side effects of valsartan, but it can help to alleviate the financial burden caused by medical expenses and lost wages. A pharmaceutical products liability attorney may be able to help you recover compensation.