FDA's Slow Assessment Over Valsartan Cancer Review

FDA's Slow Assessment Over Valsartan Cancer Review

Introduction

A new analysis by the U.S. Public Interest Research Group (U.S. PIRG) indicates that the U.S. Food & Drug Administration (FDA) took a long time to evaluate the safety of Valsartan and other generic heart and blood pressure drugs.

FDA began a series of recall in July 2018, after finding that the drug contained elevated levels of N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) or N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), following which other similar drugs like  generic losartan and irbesartan pills were also recalled. The use of these drugs has been linked to reports of liver cancer, stomach cancer, small intestine cancer, colorectal cancer, esophageal cancer, and other digestive tract cancers.

According to a report issued on October 10, U.S. PIRG showed that the FDA only assessed a quarter of valsartan and other blood pressure drugs for cancer-causing impurities. The report further indicates that around three-quarters of valsartan and similar drugs are yet to be checked,  which the FDA had claimed to be done in about six months in February 2019. The analysis shows that about 26% of all drugs present in the market has been reviewed, out of which 61% had high levels of contaminants.

The FDA has been recommended to provide resources and tools to the companies whose drugs have been tested as free of contaminants to increase production. The agency has also been asked to set a clear timeline for the evaluation and help doctors and pharmacists to suggest an alternative.

Earlier, U.S. District Judge Robert B. Kugler in the District of New Jersey ordered the plaintiffs to submit a Plaintiff Fact Sheet (PFS), giving case-specific information about their valsartan cancer diagnoses and exposure.

According to a case management order published last week, each individual who filed Short Form Complaint in the valsartan litigation should complete a PFS within 90 days. The order includes individuals diagnosed with cancer, plaintiffs seeking medical monitoring through valsartan class action claims, and plaintiffs claiming other economic loss.

It is expected that Judge Kugler will establish a “bellwether” process, as part of the coordinated pretrial proceedings, where the parties will select a representative group of cases based on the information provided on the fact sheet. The group of cases will help the parties gauge how juries may respond to evidence and testimony, which will be repeated throughout the litigation.

Valsartan is used to treat high blood pressure and heart failure. It is also used to improve the chance of living longer after a heart attack. In people with heart failure, it may also lower the chance of having to go to the hospital for heart failure. Valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels so that blood can flow more easily. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

Valsartan lawsuits filed across the country claim their use of toxic valsartan pills contributed to their cancer diagnoses. Plaintiffs claim cancers including liver cancer, small intestine cancer, stomach cancer, esophageal cancer, pancreatic cancer, and prostate cancers among others.

Nearly 130 product liability lawsuits and class action claims involving valsartan are currently pending in the federal court system. The complaints raise similar allegations that the pills were contaminated with N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and other chemicals, which are known to increase the risk of cancers. The long term exposure to these chemicals causes liver cancer, stomach cancer, small intestine cancer, esophageal cancer, prostate cancer, pancreatic cancer, and other cancers.