Contaminated Valsartan May Compromise Health of Thousands

As news of the valsartan scandal spreads and the FDA investigation picks up steam, a growing number of concerned patients have looked into filing lawsuits against the manufacturer of the contaminated drug. The problem with valsartan first became apparent in July 2018, when European regulators released information indicating that tests on ingredients provided by a Chinese company tested positive for a contaminant. That company is Zhejiang Huahai Pharmaceuticals and the contaminant is N-nitrosodimethylamine (NDMA)—a known human carcinogen linked to an increased risk of digestive system cancers, including liver cancer.

FDA bans all products from Chinese pharmaceutical company

The FDA has taken swift action in response to the report, launching a recall on July 13 and further investigating the source of the contamination. Since that time, the FDA has expanded the recall on multiple occasions. Finally, the FDA banned all imports from Zhejiang Huahai Pharmaceuticals. It had been determined that many drug ingredients sourced from that manufacturer were contaminated with NDMA.

The decision to ban all products from the company came following the FDA’s inspection report of the manufacturing facility. The FDA’s report echoed the findings by the European regulators. It stated that the facility initiated validation processes without properly conducting formal risk assessments. The report also listed problems with the outside laboratory that the plant contracted with, and with the quality of instruments and calibration of measuring devices. The FDA inspectors found that the facility’s “manufacturing processes are not always capable of consistently producing final products meeting all product quality specifications.” These were just a few of the problems detailed in the 11-page inspection report.

Valsartan recall letters issued

Valsartan is a generic medication commonly prescribed to patients receiving cardiovascular care. It’s often prescribed to manage high blood pressure, but may also be used for patients with heart failure. Many of the patients who have been prescribed valsartan have recently received recall letters by pharmacies and insurance companies. One of the companies, Tricare, which administers medical benefits for military servicemembers, indicated that the valsartan recalls affected over 30,000 of its members.

It’s important for patients to continue taking medications as prescribed unless their doctor instructs them otherwise. However, any patients who take valsartan, whether they receive recall notices or not, are encouraged to check their medication labels and contact their doctors or pharmacies for further guidance.

The FDA has established an ad hoc group of nurses and pharmacists to respond to recall inquiries from patients and healthcare providers. Since its establishment, the group has fielded more than 6,000 questions about the valsartan recalls. Consumers affected or potentially affected by the valsartan contamination can call 855-543-3784 or email [email protected].

Growing number of lawsuits filed regarding valsartan

Class action lawsuits have been filed on behalf of consumers who have suffered complications as an alleged result of valsartan contamination. The first class action lawsuit was filed in September in New York. The complaint accuses the defendants of negligence, fraud, and manufacturing a defective product.

Other defective drug lawsuits continue to be investigated as consumers consider their options for legal recourse. Product liability lawyers are looking into potential lawsuits on behalf of individuals who have used valsartan and later been diagnosed with liver, kidney, pancreatic, or stomach cancers.

Additional resources:

1. FDA, Valsartan Inspection Report, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM621162.pdf
2. FDA, FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity, https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm613532.htm