Antidiabetic slimming drugs, Ema: “There is no evidence on the risk of suicide and self-harm”

There is insufficient evidence to say that weight-loss diabetes drugs cause risks of suicide, suicidal thoughts or self-harm. “The available evidence – communicates the European Medicines Agency EMA – does not support a causal association between Glp-1 receptor agonists”, i.e. “dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide” which is the active ingredient of the best-known Ozempic*, and these psychiatric effects. This is what the EMA PRAC Security Committee concluded in its last meeting on 8-11 April.

Analogues of the Glp-1 hormone, recalls the EMA, “are used to treat type 2 diabetes and some are also authorized for weight control, in certain conditions in obese or overweight adults”. The Prac review “began in July 2023, after reports of cases of suicidal or self-harm thoughts by people using medicines based on liraglutide and semaglutide. In November 2023”, therefore, “the Prac requested additional data to the holders of the Marketing Authorization “Aic” for these medicines, marketed under the brands “Ozempic, Rybelsus*, Wegovy*, Victoza*, Saxenda*, Xultophy*, Byetta*, Bydureon*, Lyxumia*, Suliqua * and Trulicity*”, lists the EU regulatory body in a note.

“Furthermore – we read – the committee analyzed the results of a recent study based on a large database of electronic medical records, which evaluated the incidence of suicidal thoughts in patients with overweight and type 2 diabetes treated with semaglutide or with other drugs against diabetes and overweight, non-agonists of the Glp-1 receptor”, i.e. belonging to different families. “The study found no causal association between the use of semaglutide and suicidal thoughts. Another study was conducted by the EMA based on electronic medical records, examining the risk of events related to suicide and self-harm in people with type 2 diabetes. The results did not support a causal association between the use of Glp-1 receptor agonists and this risk.”

In conclusion, “after reviewing the available evidence from non-clinical studies, clinical trials, post-marketing surveillance data and available studies, the PRAC considers that no update of the product information is warranted” for these medicines. “MA holders – specifies the EMA – will continue to carefully monitor these events, including any new publications, as part of their pharmacovigilance activities and will report any new evidence on this topic in their periodic safety update reports (Psur) “.