A federal judicial panel has created a multidistrict litigation for the first 10 valsartan blood pressure medication lawsuits.

The 10 original lawsuits name Zhejiang Huahai Pharmaceutical Co. and several of its U.S. affiliates as defendants. Patients in these lawsuits allege they developed cancer because of contaminants in valsartan. The threat of contamination has precipitated a wave of recalls of blood pressure medications in the U.S. and abroad.

The valsartan lawsuits will be consolidated in a federal court in New Jersey, according to an order by the Judicial Panel on Multidistrict Litigation. Other valsartan lawsuits are expected to be transferred to this MDL or filed directly into it.

Valsartan Blood Pressure Medication

Valsartan is the generic form of brand name blood pressure medication Diovan. Diovan has not been affiliated with any contaminations.

Valsartan itself is not the problem, but certain lots manufactured at particular facilities have been found to be tainted with NDMA (N-nitrosodimethylamine), a probable human carcinogen that has been found to be a byproduct of some manufacturing processes.

The U.S. Food and Drug Administration (FDA) found trace amounts of NDMA in valsartan samples taken from Zhejiang Huahai Pharmaceutical Co. Ltd. The FDA then announced a voluntary recall of many brands of generic valsartan and valsartan-based combination drugs.

NDMA has been used in the production of liquid rocket fuel, and the Environmental Protection Agency has noted that NDMA causes tumors in the liver, respiratory tract, kidneys and blood vessels of mice and rats.

The FDA says “0.096 micrograms of NDMA per day is considered reasonably safe for human ingestion based on lifetime exposure.”

The FDA had earlier predictions that if 8,000 patients took the highest valsartan dose (320 mcg) contaminated with NDMA from the recalled lots every day for four years, there might be one additional case of cancer over the lifetimes of those 8,000 people. The FDA realizes many people take lower doses and expect the actual cancer risk among valsartan consumers to be lower than the agency’s estimate.

Patients who have taken valsartan for years may not realize that a cancer diagnosis could be linked to contaminated valsartan. Cancer is not a known valsartan side effect, but it may be caused by the NDMA contaminant.

More Valsartan Blood Pressure Drug Recalls

Earlier this month, another 126 lots of valsartan were recalled due to the discovery of trace amounts of NDEA (N-nitrosodiethylamine), another probable carcinogen.

Aurobindo Pharma recalled valsartan and valsartan/amlodipine combination pills that were tainted with NDEA. Pills in 40 mg, 80 mg, 160 mg and 320 mg under the names AurobindoPharma USA and Acetris Health LLC are subject to that recall.

In addition, Camber Pharmaceuticals Inc. recalled 87 lots of losartan that were at risk for being tainted with N-Nitroso N-Methyl 4-amino butyric acid (NMBA), which also is a potential cancer-causing agent. These lots were made at Hetero Labs Limited in India.

As more lots of valsartan blood pressure medication and similar generic blood pressure drugs are found to be contaminated, the potential total number of recalls and the size of the MDLs may both increase.