The European Medicines Agency (EMA) is currently conducting an investigation into Novo Nordisk’s diabetes drug Ozempic and weight-loss treatment Saxenda due to concerns about patients’ thoughts of suicide or self-harm. The Icelandic health regulator alerted the EMA after three cases were reported. As a result of this news, shares of Novo Nordisk fell by 1% on Monday.
The EMA’s safety committee is looking into these adverse events, including two cases of suicidal thoughts among users of Ozempic, which contains semaglutide, and Saxenda, which contains liraglutide. Another patient who used Saxenda reported thoughts of self-injury.
Novo Nordisk has emphasized that patient safety is its top priority and that it takes all reports of adverse events seriously. The company’s own safety monitoring has not found any causal association between the drugs and self-harming thoughts.
The EMA’s investigation focuses on medicines that contain semaglutide or liraglutide. Novo Nordisk’s obesity treatment, Wegovy, which has been in high demand in the United States, contains semaglutide. This review comes after the regulator raised concerns about thyroid cancer safety associated with several products containing semaglutide.
While suicidal thoughts are not listed as a side effect in the European Union product information for these drugs, the prescribing instructions for Wegovy in the United States recommend monitoring patients for such thoughts or behavior. Reports from the U.S. Food and Drug Administration indicate that there have been at least 60 reports of suicidal ideation since 2018 among patients using semaglutide and at least 70 such reports since 2010 among users of liraglutide.
The FDA states that it continuously monitors the safety of drugs throughout their life cycle. While Wegovy’s clinical trials did not suggest an increased risk of suicidal behavior, the drug’s label contains a warning for such behavior due to risks associated with other weight management drugs.
Although Iceland’s regulator has only reported three cases, the issue of suicidal thoughts linked to weight-loss drugs is sensitive and has hindered previous attempts to develop lucrative weight-loss drugs. Novo Nordisk’s clinical trials excluded individuals with a history of psychiatric disorders or recent suicidal behavior. Past weight-loss drugs, such as Sanofi’s Acomplia, have been withdrawn from the market due to their association with suicidal thoughts.
Markus Manns, a senior portfolio manager at Union Investment and a Novo Nordisk shareholder, commented that a low incidence of suicidal thoughts may be acceptable for a drug targeted at Type 2 diabetes but not for a weight-loss drug.
The EMA has indicated that it may extend the review to other GLP-1 receptor agonists, which are drugs of the same class as Ozempic and Saxenda. Other drugs within this class include Lilly’s Mounjaro. Penny Ward, a pharmaceutical medicine expert, suggests that the most likely outcome of the investigation would be a change in the drug’s label in the EU to include a warning about the possible side effect of suicidal thoughts.
The investigation initiated by Iceland’s regulator may be limited in scope due to the small size of the country’s population, according to an anonymous drug safety expert.
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