Ozempic, Saxenda drugs under EU probe over reports of suicidal thoughts

The review has been announced weeks after the regulator raised a thyroid cancer safety signal on several of Novo's products that contain semaglutide.

The European Medicines Agency (EMA) is investigating Novo Nordisk’s NOVOb.CO diabetes drug Ozempic and weight-loss treatment Saxenda after Iceland’s health regulator flagged three cases of patients thinking about suicide or self-harm.

Shares of the Danish drugmaker fell one per cent on Monday following the news.

An 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, the regulator said.

Another patient on Saxenda, Novo’s earlier and less effective weight-loss drug that contains a different active ingredient, reported thoughts of self-injury, the agency said.

Novo Nordisk said patient safety was top priority and it treated all reports about adverse events very seriously.

Safety data did not show any “causal association” between the suicidal or self-harming thoughts and the drugs, it added in a statement.

The EMA’s investigation centres on medicines that contain either semaglutide or liraglutide. Novo’s obesity treatment Wegovy, for which demand has surged in the United States, contains semaglutide, while Saxenda contains liraglutide.

The review has been announced weeks after the regulator raised a thyroid cancer safety signal, a means to monitor potentially adverse effects, on several of Novo’s products that contain semaglutide.