European Regulators Seek More Data on Ozempic Suicide Risks

European regulators indicate that they need more data about the potential side effects of Ozempic, Wegovy and similar drugs, to determine whether the popular diabetes and weight loss medications may cause thoughts of suicide and self-harm.

In July, the European Medicines Agency (EMA) began investigating Ozempic suicide risks, which has now grown into a broader investigation into other drugs belonging to the same new class of medications, known as glucagon-like peptide-1 (GLP-1) receptor agonists.

The review was launched amid concerns about reports of patients experiencing suicidal ideations on Ozempic and other similar drugs, as the popularity of the drugs continues to increase. However, at a meeting of its Pharmacovigilance Risk Assessment Committee (PRAC) held late last month, investigators said they still have not determined if there is a causal link between the medications and suicide risks.

Ozempic, Wegovy, Mounjaro and other GLP-1 receptor agonists have become blockbuster medications worldwide over the past year. While originally designed to treat type 2 diabetes, the drugs have been increasingly used among non-diabetics to help lose weight quickly.

While PRAC investigators are focused on the drugs’ potential ability to create suicidal ideations, other concerns have emerged in the U.S. about growing reports of certain users experiencing a painful and debilitating form of stomach paralysis, known as gastroparesis. As a result of the drug makers’ failure to warn about these risks, many former users are now filing Ozempic lawsuits, Wegovy lawsuits and Mounjaro lawsuits throughout the U.S. court system.

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.

Novo Nordisk claims there are no known causal connections between Ozempic and suicide, and the two drugs do not carry label warnings in the 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.

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 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.

Following several months of investigation into data on the drugs’ clinical trials, post-marketing surveillance data and published literature, the PRAC indicated at its November meeting that it does not yet have enough data to determine if there is a link between suicidal ideations and GLP-1 receptor agonists.

“While at this point no conclusion can be drawn on a causal association, there are several issues that still need to be clarified,” the PRAC wrote. “The committee has agreed further lists of questions to be addressed by the respective marketing authorization holders for these medicines, namely Ozempic, Rybelsus, Wegovy, Victoza, Saxenda, Xultophy, Byetta, Bydureon, Lyxumia, Suliqua and Trulicity.”

The committee indicates it will provide an update on the investigation at its meeting in April.

December 2023 Ozempic Lawsuit Update

In the U.S., dozens of individuals have already filed gastroparesis lawsuits against the makers of Ozempic, Wegovy and Mounjaro, withgastroparesis lawyers indicate they are currently investigating potential claims for more than 10,000 additional individuals.

In December 2023, a group of plaintiffs filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) calling for the centralization of all Ozempic lawsuits filed in the U.S., asking that the claims be consolidated before one judge for coordinated discovery and pretrial procedures.

In complex pharmaceutical litigation, where large numbers of claims are brought by users of the same medication or medical product, each experiencing the same or similar injuries, it is common for the U.S. JPML to centralize the litigation to reduce duplicative discovery into common issues that will arise in all claims, avoid conflicting pretrial rulings and to serve the convenience of certain witnesses and parties who will be required to testify in each of the lawsuits.

If an MDL is established and the parties fail to negotiate Ozempic, Wegovy and Mounjaro lawsuit settlements or reach another resolution, each individual claim may later be remanded back to the U.S. District Court where it was originally filed for trial.