FDA Has Linked More Than 100 Deaths to Ozempic, Wegovy and Similar Drugs: Report

As a growing number of individuals turn to Ozempic, Wegovy and other new drugs to help manage their diabetes and promote weight loss, federal health officials have received a rising number of adverse event reports involving users who experienced severe and life threatening adverse events, and a prominent news organization now suggests that more than 100 deaths may have been linked to the medications.

According to a report published last week by The Daily Mail, the U.S. Food and Drug Administration (FDA) has received 117 incident reports involving deaths among individuals taking glucagon-like peptide-1 receptor agonists (GLP-1 RA), including Ozempic, Wegovy and Mounjaro. The reports are mostly linked to gastrointestinal issues like masses and stomach paralysis.

Ozempic, Wegovy, Mounjaro and other GLP-1 RA drugs have become blockbuster treatments over the past year, given the widespread promotion of the medications as safe and effective for weight loss. However, evidence has emerged that certain users experience a painful and debilitating stomach paralysis, known as gastroparesis, which lawsuits now allege was not fully disclosed by the drug makers on the warning labels.

GLP-1 Side Effects

Ozempic (semaglutide) was initially introduced for the treatment of people with Type 2 diabetes. However, amid aggressive advertisements that promoted the weight loss benefits, Ozempic has been increasingly prescribed as a diet drug, making it a blockbuster treatment that is now used by millions of Americans.

As a result of the popularity of Ozempic for weight loss, Novo Nordisk has introduced a higher dose version under the brand name Wegovy, which is specifically approved as a diet drug. However, it contains the same active ingredient.

Eli Lilly has also released competing GLP-1 drugs in the form of Mounjaro (tirzepatide), approved for diabetes treatment in 2022, and a weight loss version of the drug was approved by the FDA last year, which is marketed under the brand name Zepbound.

Although advertisements promote the drugs as safe and effective, with few long-term side effects, former users are now pursuing Ozempic lawsuits, Wegovy lawsuits and Mounjaro lawsuits against the manufacturers, each raising similar allegations that the drug labels fail to adequately warn about the risk of severe and long-lasting side effects, including gastroparesis.

The Daily Mail analyzed reports submitted to the FDA’s Adverse Event Reporting System (FAERS). Of the 117 incidents reported, 81 were linked to the use of Ozempic and Wegovy, and another 36 were linked to the use of Mounjaro. No deaths have been linked to Zepbound use.

The FDA reports indicate that more than half of the deaths, 56, linked to semaglutide drugs were reported after Wegovy hit the market in June 2021.

While the reports do not mean that the drugs were the cause of the deaths, many incidents reported symptoms linked to gastroparesis, and also included reports of seizures and pancreatic cancer.

The report found a 230% increase in GLP-1 RA-related deaths in 2023, compared to previous years. However, the Daily Mail notes this could be linked to the drugs’ increased popularity as weight loss treatments.

No Evidence of GLP-1 Suicide Risks, EU Regulators Find

These latest findings came just as the regulators at the European Medicines Agency (EMA) issued a press release on April 12, indicating that there is no evidence to support a link between GLP-1 RAs and suicide.

In July, the EMA launched an investigation into Ozempic suicide risks amid reports of patients experiencing suicidal ideations.

The EMA’s investigation into the medications came following reports from Iceland of patients reporting having suicidal thoughts. The reports involved both Ozempic and Saxenda, both of which use semiglutide as the active ingredient.

In the U.S., semaglutide-based drugs have been linked to at least 60 reports of suicide ideation since 2018. Suicide risks and ideations have long been linked to weight loss drugs, such as Contrave and Qsymia, making it difficult for them to gain approval in the U.S. However, Wegovy and similar drugs are being approved at a rapid rate, since they are much more effective than earlier obesity treatments.

EMA regulators said their own review, and data from two other studies “found no causal association between the use of GLP-1 receptor agonists” and suicide. The FDA reached a similar conclusion in January.

April 2024 Ozempic Gastroparesis Lawsuit Update

Given common questions of fact and law raised in gastroparesis lawsuits filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided to centralize all GLP-1 lawsuits earlier this year, transferring any claims involving gastrointestinal injuries among users of Ozempic, Wegovy, Mounjaro or other similar medications to U.S. District Judge Gene E.K. Pratter in the U.S. District Court for the Eastern District of Pennsylvania.

It is widely expected that thousands of claims will be transferred to the Ozempic litigation as lawyer continue to review and file claims in the coming months, as some estimates indicate nearly 2% of the U.S. population has been prescribed one of the GLP-1 medications, either for diabetes treatment or weight loss.

To help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation, it is expected that Judge Pratter will establish a bellwether process to prepare a small group of Ozempic side effect lawsuits for early trial dates. However, if the parties are unable to negotiate settlements or another resolution for the litigation after the bellwether trials, the Court may later remand each case back to the U.S. District Court where it was originally filed for trial.