Weight Loss Drugs And Associated Suicidal Thoughts - European Drug Regulator Seeks Clarifications From Drug Makers

European Medicines Agency (EMA) will request further clarifications from drugmakers of GLP-1 receptor agonists for diabetes and weight loss, including Novo Nordisk A/S's NVO popular therapies Ozempic and Wegovy, to investigate suicidal thoughts further.

"While at this point no conclusion can be drawn on a causal association, there are several issues that still need to be clarified," the EMA said in a statement.

EMA's Pharmacovigilance Risk Assessment Committee (PRAC) will discuss the topic again at its meeting in April 2024.

The PRAC has reviewed the available evidence from clinical trials, post-marketing surveillance, and the published literature on reported cases of suicidal thoughts and thoughts of self-harm with GLP-1 receptor agonists.

The committee has agreed further lists of questions to be addressed by the respective marketing authorization holders for these medicines, namely Novo Nordisk's Ozempic, Rybelsus, Wegovy, Saxenda, Victoza, and Xultophy; AstraZeneca Plc's AZN Byetta and Bydureon; Sanofi SA's SNY Lyxumia, and Suliqua; and Eli Lilly And Co's LLY Trulicity.

In July, the EMA received reports from the Icelandic Medicines Agency of two cases of suicidal thoughts linked to the drugs Saxenda and Ozempic.

An additional case of self-injury ideation associated with Saxenda was also reported.

There were also reports that U.S. psychiatrists were increasingly prescribing Wegovy to patients who have gained weight due to medicines for mental disorders like schizophrenia or bipolar disorder.