FDA Finds No Evidence of Ozempic, Wegovy Suicide Risks

The agency notes it has not completely ruled out the suicide risk, and it is continuing to investigate the potential side effects of Ozempic, Wegovy, Mounjaro and similar diabetes or weight loss drugs.

Days after media reports confirmed that the U.S. Food and Drug Administration (FDA) was investigating a potential link between Ozempic, Wegovy and suicides, federal reglators have released a statement indicating that they see few signs of evidence that the widely used class of weight loss and diabetes drugs increase the risk of self-harm.

The U.S. Food and Drug Administration (FDA) issued a drug safety communication on January 11, announcing that a preliminary evaluation of a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists, which include Ozempic, Wegovy, Mounjaro, Zepbound and others, has revealed no evidence that using them leads to suicidal thoughts or actions.

The announcement comes after an FDA quarterly report on adverse drug events released on January 2 that revealed the agency had received 201 reports of suicide or suicidal ideations linked to the medications by the end of September 2023. At the time, the FDA indicated it was evaluating the drugs for “the need for regulatory action.”

Ozempic, Wegovy, Mounjaro Health Concerns

The announcement and investigation come amid growing concerns over the class of medications, which are quickly rising in popularity.

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 in recent years, 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 Mounjaro lawsuits, Ozempic lawsuits and Wegovy lawsuits against the manufacturers, each raising similar allegations that the widespread use of the drugs has made it clear that the drug label fails to adequately warn about the risk of severe and long-lasting gastroparesis, or stomach paralysis, side effects.

Ozempic, Wegovy, Mounjaro Suicide Risk Investigation

The FDA safety communication indicates that the agency has been reviewing reports of suicidal thoughts or actions linked to the medications for several months, but is finding no pattern suggesting the drugs are the cause of these recent incidents.

“Because the information provided was often limited and because these events can be influenced by other potential factors, the FDA determined that the information in these reports did not demonstrate a clear relationship with the use of GLP-1 RAs,” the agency states. “Similarly, the FDA’s reviews of the clinical trials, including large outcome studies and observational studies did not find an association between the use of GLP-1 RAs and the occurrence of suicidal thoughts and actions.”

The FDA indicates these preliminary findings do not rule out a link between drugs like Ozempic and suicide risks. Therefore, the agency is continuing its investigation as a result.

An investigation is also underway by the European Union’s European Medicines Agency (EMA), which began investigating Ozempic suicide risks in July 2023, following similar reports from Iceland of patients having suicidal thoughts. The reports involved both Ozempic and Saxenda (liraglutide).

Novo Nordisk claims there are no known causal connections between Ozempic and suicide, and the two drugs do not carry label warnings in the United States or EU alerting patients to potential suicidal thoughts risks. However, the drug Wegovy, which is also a weight loss medication sold in the U.S. using semaglutide, does carry such a warning, calling for patients taking the drug to be monitored for suicidal thoughts and behaviors.

Suicide risks and ideations have long been linked to weight loss drugs, such as Contrave and Qsymia, making it difficult for them to gain approved 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.

FDA Ozempic Suicide Risk Recommendations

The safety communication includes a number of recommendations for patients using the drugs, indicating they should not stop taking the medications without first consulting their doctors. The FDA indicates patients should tell their doctors if they experience worsening depression, suicidal thoughts or unusual changes in mood or behavior.

The agency also recommends doctors monitor patients on these drugs for signs of these mood changes as well, and should consult the prescribing information when treating patients with these medications.

Both doctors and patients should report any adverse events or side effects related to these drugs to the FDA’s MedWatch adverse event reporting program.

January 2024 Ozempic Side Effects Lawsuits Update

The FDA report comes as a growing number of  complaints are being filed in U.S. District Courts nationwide, each describing circumstances where users experienced permanent injuries from gastroparesis side effects from Ozempic, Wegovy or Mounjaro.

Given common questions of fact and law raised in the cases, a group of plaintiffs filed a motion to centralize all Ozempic gastroparesis lawsuits on December 1, asking the U.S. Judicial Panel on Multidistrict Litigation (JPML) to transfer claims brought throughout the federal court system to the U.S. District Court for the Western District of Louisiana, for coordinated management before one judge during discovery and pretrial proceedings. The panel will hear oral arguments on the motion later this month.

While the motion indicates there are currently less than two dozen cases filed in different U.S. District Courts, lawyers are currently investigating more than 10,000 additional claims that may be filed in the coming months and years.