EU investigates Ozempic, Saxenda after reports of suicidal thoughts

The European Medicines Agency is investigating the diabetes drug Novo Nordisks, Ozempic, and the weight-loss treatment Saxenda, after Iceland’s health regulator reported three cases of patients contemplating suicide or self-harm.

Shares of the Danish drugmaker fell 1% on Monday following the news.

A safety committee of the European Medicines Agency, or EMA, is looking into adverse events raised by the Icelandic Medicines Agency, including two cases of suicidal thoughts in those who have used Ozempic, which contains the active ingredient semaglutide. and Saxenda, the regulator said.

Another patient taking Saxenda, Novos earlier and less effective weight-loss drug that contains the active ingredient liraglutide, reported thoughts of self-harm, the agency said.

Iceland’s drug regulator did not immediately respond to requests for details.

Novo Nordisk has stated that patient safety is the top priority and has taken all adverse event reports very seriously. Its safety monitoring so far has found no causal association between self-harm thoughts and drugs, it said in a statement.

EMA’s investigation focuses on medicines that contain semaglutide or liraglutide. The obesity treatment Novos Wegovy, for which demand has increased in the United States, contains semaglutide.

The review was announced weeks after the regulator launched a thyroid cancer safety signal, a means of monitoring for potentially adverse effects, on several Novos products containing semaglutide.

Suicidal thoughts are not listed as a side effect in the EU product information for either drug.

In the United States, however, Wegovy’s prescribing instructions recommend that patients be monitored for suicidal thoughts or behaviors.

According to the U.S. Food and Drug Administration’s Adverse Event Reporting System Public Dashboard, there have been at least 60 reports of suicidal ideation by patients taking semaglutide or their healthcare providers since 2018.

The database has received at least 70 such reports since 2010 from liraglutide users or their healthcare professionals.

The information in these reports has not been verified and the existence of a relationship is not proof of causation, says the FDA.

The FDA said it monitors the safety of drugs throughout their life cycle. Wegovys’ studies have not suggested an increased risk of suicidal behavior, but the drug’s label carries a warning for suicidal behavior and ideation because of the risks associated with other weight-management drugs, the regulator said.

Although the Icelandic regulator has only reported three cases, the issue of suicidal thoughts linked to diet drugs is a sensitive one and has hampered the pharmaceutical industry’s previous attempts to develop profitable diet drugs.

In clinical studies for Ozempic and Saxenda, Novo excluded people with a history of psychiatric disorders or recent suicidal behaviors.

Sanofis Acomplia, which never got US approval, was withdrawn in Europe in 2008 after being linked to suicidal thoughts.

Acomplia was designed to change parts of the nervous system that regulate appetite. New diet drugs like Wegovy regulate appetite by mimicking a gut hormone and not directly interfering with brain chemistry.

Orexigen Therapeutics’ Contrave diet pills and Vivus Inc’s Qsymia, approved in the United States in 2014 and 2012, respectively, carry warnings on their labels about an increased risk of suicidal thoughts.

Markus Manns, senior portfolio manager at Union Investment and a shareholder in Novo, said a low incidence of suicidal thoughts might be acceptable for a type 2 diabetes drug but not for a diet drug.

EMA said on Monday it would consider whether the review should be extended to other medicines in the same class, known as GLP-1 receptor agonists.

EMA’s ongoing thyroid cancer investigation includes all GLP-1s.

Other drugs in the class include Eli Lilly and CosMounjaro. Lilly did not respond to a question from Reuters about whether the EMA had contacted them to provide data for the new investigation.

Penny Ward, a visiting professor of pharmaceutical medicine at Kings College London and an expert on drug safety monitoring in the EU, said the most likely outcome of the investigation would be a change in the labeling of medicines in the EU to bring a warning of the possible side effect of suicidal thoughts.

If you or someone you know is in crisis, call 988 to reach the Suicide and Crisis Lifeline. You can also call the network, formerly known as the National Suicide Prevention Lifeline, at800-273-8255text HOME to 741741 or visitSpeakingOfSuicide.com/resourcesfor additional resources.

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