While Effective, Victoza Side Effects Linked To Gastrointestinal Problems In Children: Study
While Victoza has been shown to be a potentially useful diabetes treatment for children, the findings of new research suggests that side effects may increase the risk of potentially serious gastrointestinal adverse events.
In a study funded by the manufacturer of Victoza, Novo Nordisk, researchers found that the medication was effective in the treatment of children with type 2 diabetes, but warned that it was frequently linked to gastrointestinal side effects. The findings were published late last month in the New England Journal of Medicine.
Victoza (liraglutide) is an injectable diabetes drug introduced by Novo Nordisk in 2010. While it is currently approved for use by adults, this latest study sought to determine whether Victoza was safe and effective for children when combined with the first-line diabetes treatment drug metformin.
The study involved 134 patients between the ages of 10 and 17. Researchers then assigned 66 patients to take up to 1.8 mg of Victoza per day, while another 68 patients were given a placebo. The children underwent a 26-week double blind clinical trial where researchers looked for the impact on glycated hemoglobin levels as well as adverse effects.
According to the findings, while Victoza helped increase glycemic control, nearly 85% of those given the drug reported adverse events. While just over 80% of the children given a placebo also reported adverse events, researchers determined that the overall rate of adverse events, and specifically gastrointestinal adverse events, were higher among children given Victoza.
“In children and adolescents with type 2 diabetes, liraglutide, at a dose of up to 1.8 mg per day, was efficacious in improving glycemic control over 52 weeks,” the researchers concluded. “This efficacy came at the cost of an increased frequency of gastrointestinal adverse events.”
Victoza Health Risks
Victoza is part of a popular class of diabetes medications, known as increatin mimetics, which have been linked to an increased risk of pancreatitis in the past. In recent years, hundreds of lawsuits have been filed that allege these side effects of Victoza resulted in pancreatic cancer, yet drug makers failed to warn consumers and the medical community about the potential risk.
Given similar questions of fact and law raised in cases filed throughout the federal court system, the litigation was centralized before U.S. District Judge Anthony Battaglia in the Southern District of California in 2013.
Following coordinated discovery and pretrial proceedings, Judge Battaglia dismissed the litigation in 2015, finding that the claims were preempted by federal law, since he believed there was sufficient evidence to establish that the FDA would not have approved any request by the drug makers to add pancreatic cancer warnings to the drug labels.
The U.S. Court of Appeals for the Ninth Circuit overturned that ruling in December 2017, reinstating about 700 lawsuits and returning the cases back to Judge Battaglia for coordinated pretrial proceedings, which had been paused for about two years.