EU investigates Ozempic and weight loss drug Saxenda after reports of suicidal thoughts – 7/10/2023

Written by Ludwig Berger and Maggie Vick

(Reuters) – The European Medicines Agency (EMA) is investigating Novo Nordisk’s diabetes drug Ozempic and weight loss drug Saxenda, after Iceland’s health authority identified three cases of patients with suicidal thoughts or self-mutilation.

Shares of the Danish pharmaceutical company fell 1% on Monday after the news.

The regulatory agency said the EMA Safety Committee is looking into adverse events raised by the Icelandic Medicines Agency, including two cases of suicidal thoughts in those who used Ozempic, which contains the active ingredient semaglutide, and Saxenda.

Another patient who took Saxenda, a previous and less effective weight-loss drug made by Novo Nordisk that contains the active ingredient liraglutide, the agency said, reported thoughts of self-harm.

Iceland’s Medicines Regulatory Authority did not immediately respond to requests for details.

Novo Nordisk said that patient safety is its top priority and that it takes all reports of adverse events very seriously. To date, its safety oversight has not found a “causal association” between self-destructive thoughts and medication, it said in a statement.

The EMA investigation is focused on drugs that contain either semaglutide or liraglutide.

Suicidal thoughts are not listed as a side effect in the EU product information for any of the medicines.

(Reporting by Bhanvi Satija in Bengaluru, Michael Erman and Patrick Wingrove in New York, Robin Respaut in San Francisco, Louise Breusch Rasmussen in Copenhagen, and Jennifer Rigby in London).