FDA Increases Drug Quality Oversight in Wake of Valsartan Recall

Published on November 15, 2018 by Sandy Liebhard

The head of the U.S. Food & Drug Administration (FDA) has promised to focus on drug quality, following a world-wide valsartan recall for heart and blood pressure medications that may have been contaminated with a cancer-causing chemical.

“We put out very big guidance on this – it’s a known risk,” FDA Commissioner Scott Gottlieb recently told USA Today on Wednesday. “It’s a place where there’s been a significant increase in focus in recent years.”

Why Was Valsartan Recalled?

Valsartan is the generic name for Diovan, a medication indicated to treat heart failure and high blood pressure. Until recently, roughly half of the active pharmaceutical ingredient (API) used by generic valsartan manufacturers in the United States was sourced from China-based Zhejiang Huahai Pharmaceutical Company.

The valsartan recalls began in June, after N-nitrosodimethylamine (NDMA), a known human carcinogen, was found in Zhejiang Huahai’s API. Studies involving animals have linked NDMA to tumors of the liver, respiratory tract, kidneys and blood vessels.

The FDA’s scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full four years, there might be one additional case of cancer over the lifetimes of those 8,000 people.

Contamination Issues Extend to Other Heart and Blood Pressure Drugs

Although it hasn’t yet identified a root cause, the FDA suspects that the NDMA contamination resulted from an alteration in Zhejiang Huahai’s production methods that occurred in 2014. Thus, it’s possible that tainted valsartan tablets were in circulation for the last 4 years.

The FDA has banned the company’s drug products and API from entering the United States, following an agency inspection that uncovered several problems at its factory in Zinhai, China.

Unfortunately, valsartan tablets aren’t the only heart and blood pressure medications impacted by contamination issues. Most recently, for example, several generic drug makers have recalled losartan and irbesartan tablets that may have been contaminated with N-nitrosodiethylamine, or NDEA.

NDEA has been designated a probable human carcinogen by the World Health Organization’s International Agency for Research on Cancer.

Valsartan Recall Lawsuits Mount in U.S. Courts

Zhejiang Huahai Pharmaceuticals and various generic drug makers have been named defendants in a growing number of valsartan lawsuits filed in courts throughout the United States.

Many of the lawsuits seek class action status on behalf of individuals who purchased allegedly dangerous and worthless valsartan tablets. Zhejiang Huahai and other defendants are accused of gross negligence, fraudulent concealment, breach of contract, and unjust enrichment.

Last month, a group of plaintiffs filed a motion with the U.S. Judicial Panel on Multidistrict Litigation seeking centralization of all federally-filed Valsartan recall claims before a single judge  the U.S. District Court, District of New Jersey. While the motion noted that only 11 valsartan lawsuits were pending in federal courts at the time, plaintiffs predicted the number of cases would grow significantly in the near future. They further asserted that centralization would promote judicial efficiency and preserve the resources of the courts, parties, and witnesses involved in the litigation.