Eight months after the European Medicines Agency (EMA) opened an investigation into a potential link between popular GLP-1 receptor agonists and suicidal thoughts or actions, the agency has determined there is no such association.
The review began in July after two cases of suicidal thoughts and one instance of self-harm were reported from Icelandic users of Novo Nordisk’s blockbuster diabetes and obesity treatments.
Along with Novo’s semaglutide products (marketed as Ozempic, Rybelsus and Wegovy), and its liraglutide meds (Saxenda and Victoza), the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) looked into the company’s Xultophy. Also included in the probe were Eli Lilly’s Trulicity, AstraZeneca’s Byetta and Bydureon, and Sanofi’s Soliqua and Adlyxin (or Suliqua and Lyxumia in Europe).
After asking for further data from the companies in November, the PRAC found that available evidence does not support a casual association between the drugs and suicidal or self-injurious thoughts or actions, according to a Friday release.
The committee further analyzed a study based on a vast database of electronic health records, plus a similar one conducted by the EMA that only included type 2 diabetes patients. Regulators also reviewed otherwise “available studies” and post-marketing data.
Even after the probe, the companies will “continue to monitor these events closely,” the European regulators noted.
In parallel, the FDA has been looking into hundreds of similar reports flagged through its FDA Adverse Event Reporting System (FAERS). In January, the U.S. agency came to the same conclusion of no clear relationship, partly due to the fact that “these events can be influenced by other potential factors,” the FDA wrote.
One factor may be the “known relationship between our food and our mood,” president of the Obesity Medicine Association and chief medical officer at weight-inclusive healthcare company knownwell Angela Fitch, M.D., said in an emailed statement. “When we change that relationship—whether with GLP-1s, surgery, or other methods, we need to ensure we monitor patients for mood changes regardless of treatment modality.”
The FDA and EMA findings are further backed by a study from Nature Journal, which pulled data from 1.8 million diabetes and obesity patients showing those who were on Novo’s semaglutide were less likely to have suicidal thoughts than patients taking other treatments.