Victoza Caused Side Effects in 80% of Children, But Helped Them Lose Weight: Study

Most of the adverse events were gastrointestinal in nature, mirroring claims being raised in thousands of Ozempic lawsuits filed over stomach paralysis and ileus.

While a new Victoza study has found that the diabetes drug can help obese children lose weight, the findings indicate that the vast majority experience severe gastrointestinal side effects, highlighting the growing health concerns linked to the class of medications, which also includes Ozempic, Wegovy, Mounjaro and others.

An international research team, funded by Novo Nordisk, found that combining the diabetes drug Victoza with lifestyle changes resulted in significant weight loss in children under 12 compared to lifestyle changes alone. The study was published as a phase three trial, indicating that the manufacturer is likely to push for either FDA-approved pediatric use, or a pediatric version of the diabetes drug, designed for weight loss.

GLP-1 Drug Concerns

Victoza (liraglutide) is one of the oldest type 2 diabetes drugs in a class of medications known as glucagon-like peptide 1 (GLP-1) receptor agonists. However, several additional brands of these GLP-1 drugs approved for diabetes treatment have surged in popularity in recent years, including Novo Nordisk’s Ozempic, Eli Lilly’s Mounjaro and others, particularly because of their off-label benefits for weight loss.

Given the drastic increase in popularity for weight loss, several of the manufacturers began to develop a weight loss version of the drugs, with Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound now approved as diet medications.

However, a growing number of individuals have reported suffering severe gastrointestinal injuries while using GLP-1 drugs, including stomach paralysis, vision and thyroid problems, raising concerns over whether the manufacturers adequately researched all of the potential health risks.

As a result, thousands of former users are now pursuing Ozempic lawsuits, Wegovy lawsuits and Mounjaro lawsuits against the manufacturer, each raising similar allegations that the drug makers failed to adequately disclose gastrointestinal problems linked to the drugs.

In this new study, a research team led by Dr. Claudia K. Fox conducted a 56-week clinical trial, which looked at 51 clinically obese children ages 6 to 12, with two-thirds being given a 3 mg dose of Victoza per day, and one-third being given a placebo. They then tracked changes in body-mass index (BMI), looking for those who decreased their BMI by at least 5% during the trial.

According to the researchers, the mean total change from baseline BMI for children given Victoza was -5.8%, exceeding the study’s -5% goal. Those taking the placebo saw a mean increase in BMI, of 1.6%.

The data shows that 46% of children treated with Victoza experienced a reduction in BMI of at least 5%. Based on these findings, the research team concluded that children who receive Victoza are likely to see a more significant decrease in BMI compared to their peers.

However, the researchers noted a high number of adverse events were experienced by the children that took the drug.

“Adverse events occurred in 89% and 88% of participants in the liraglutide and placebo groups, respectively,” the researchers determined. “Gastrointestinal adverse events were more common in the liraglutide group (80% vs. 54%); serious adverse events were reported in 12% and 8% of participants in the liraglutide and placebo groups, respectively.”

GLP-1 Side Effects Lawsuits

The findings come as those same types of gastrointestinal issues, including stomach paralysis, ileus and intestinal blockages, are behind more than 1,300 lawsuits currently being pursued by adult users against the makers of Victoza, Ozempic, Wegovy, Mounjaro and other similar diabetes and weight loss drugs. Each of the claims raises similar allegations that a desire for increased profits was placed above consumer safety, as the manufacturers failed to research and disclose gastroparesis side effects users may experience.

Given common questions of fact and law raised in complaints filed throughout the federal court system, all GLP-1 lawsuits have been centralized as part of a multidistrict litigation (MDL) in the Eastern District of Pennsylvania, where they are currently being overseen by U.S. District Judge Karen Marston.

Judge Marston has directed the parties to focus in the early stages of the litigation on “cross cutting” issues, which will impact a large number of claims. This includes discovery and pretrial motions regarding general causation evidence about the link between Ozempic and ileus, gastroparesis and other injuries, as well as questions about whether the claims are preempted by federal law and whether plaintiffs will be required to provide specific testing evidence to establish they suffered an injury.

Following the resolution of those issues, Judge Marston is expected to direct the parties to select representative GLP-1 lawsuits for early bellwether test trials, to help gauge how juries will respond to evidence and expert testimony likely to be repeated throughout the litigation.

While the outcomes of such early test trials are not binding on other claims, they could help potentially facilitate a GLP-1 settlement agreement that would avoid the need for each individual case to be set for trial in the future.