Valsartan Recalls Linked To Increase in Emergency Room Visits: Study

Following massive recalls issued world-wide last year, due to cancer causing impurities that contaminated generic valsartan drugs, researchers indicate that there was a significant spike in emergency room treatments among individuals who relied on the hypertension drug.

According to a study released this week by the non-profit group Institute for Clinical Evaluative Sciences, emergency department visits among hypertension patients impacted by valsartan recalls in Canada increased by 55%, amid widespread drug shortages and confusion. The findings highlight the need for better coordination among regulators, prescribing doctors and pharmacists when widely drugs are recalled, according to the group.

Valsartan is a generic version of the brand-name drug Diovan, which is a receptor blocking drug designed to relax blood vessels so that blood can flow more easily. The medication is widely used to manage hypertension, congestive heart failure, and also frequently given to those following a heart attack.

In July 2018, it was discovered that certain versions of generic valsartan and valsartan HCTZ distributed worldwide may contain an impurity known as N-nitrosodimethylamine (NDMA), which is a cancer-causing agent. The chemical byproduct has been linked to a risk of liver cancer, colorectal cancer, stomach cancer and other cancers along the digestive tract.

Following the discovery, valsartan recalls were issued by several different generic drug distributors, which contained active ingredients manufactured in China and other locations.

Early investigations suggested that NDMA contaminated valsartan pills due to changes in the generic drug manufacturing process, since similar problems were not seen with Diovan or certain other generic versions.

As a result of the contamination, generic valsartan pills were in short supply worldwide for months, and there was much confusion among consumers and the medical community about which versions of the hypertension drug were safe.

In this new study, researchers reviewed the impact of these recalls on just over 55,000 patients taking recalled generic valsartan drugs, and found not only did many resort to hospital visits for treatment, around 10.7% of the population did not replace their medications within three months following the recalls, leaving them susceptible to life-threatening conditions going untreated.

The report indicates that there was a 6% spike in emergency department visits for stroke patients taking valsartan, as well as an 8% jump in hospitalizations.

Researchers indicated the causes for many of the visits included patients seeking to refill their valsartan prescriptions, searching for a replacement medication, or individuals who lost control of their hypertension and required medical intervention.

Lead author, Cynthia Jackevicius indicates that it is unknown how many of the patient population may have been willing to risk the short-term risk of uncontrolled hypertension to avoid ingesting a potential carcinogen following the recall.

Valsartan Cancer Lawsuits

A number of generic drug manufacturers now face valsartan lawsuits brought by individuals diagnosed with cancers after use of the contaminated pills. As lawyers continue to review and file claims over the coming months and years, it is widely expected that several thousand cases will be filed nationwide.

Given common questions of fact and law raised in the complaints, the federal cases has been centralized before U.S. District Judge Robert B. Kugler in the District of New Jersey, as part of an MDL, or multidistrict litigation.

As part of the coordinated pretrial proceedings, it is expected that Judge Kugler will eventually establish a “bellwether” process, where the parties will use the fact sheet information about each valsartan cancer claim to select a representative group cases, which will be prepared for early trial dates in the MDL.

While the outcome of these early “bellwether” trials will not be binding on other plaintiffs, they are typically scheduled in complex pharmaceutical litigation to help the parties gauge how juries may respond to evidence and testimony that will be repeated throughout the litigation, and facilitate potential valsartan cancer settlements with the manufacturers and distributors of the contaminated pills.