Boxes of the diabetes drug Ozempic can be seen in this captivating photo illustration taken at a pharmacy counter in Los Angeles on April 17, 2023.
Mario Tama | Getty Images
The European Union’s drug regulator announced on Tuesday that it has expanded its investigation into the potential risk of patients experiencing suicidal thoughts and self-injury while taking Novo Nordisk’s Ozempic, Wegovy, and Saxenda drugs. The investigation now includes other weight loss and diabetes medications.
The European Medicines Agency (EMA) did not disclose the specific additional drugs that are being investigated, but they could potentially include Eli Lilly’s diabetes drug Mounjaro, which is approved for use in the EU. Other companies like Pfizer and Amgen are also developing similar products.
The EMA is currently evaluating approximately 150 reports of potential cases involving self-injury and suicidal thoughts in patients using weight loss and diabetes drugs. According to the agency, it is still uncertain whether these medicines caused the events or if there are any links to patients’ underlying conditions or other factors.
The EMA expects to conclude its investigation by November. The agency initiated the investigation after the Icelandic Medicines Agency identified three instances of suicidal thoughts and self-injury in patients taking drugs containing liraglutide and semaglutide, which are the active ingredients in Novo Nordisk’s weight loss drug Saxenda and its diabetes drugs Wegovy and Ozempic.
Liraglutide and semaglutide belong to a popular class of drugs known as GLP-1 receptor agonists. These drugs mimic a hormone called GLP-1, which is produced in the gut and helps suppress appetite for weight loss purposes. They can also aid in managing Type 2 diabetes by stimulating insulin release from the pancreas, thereby reducing blood sugar levels.
In response to the investigation, Novo Nordisk stated that safety data obtained from extensive clinical trial programs and post-marketing surveillance have not shown any causal association between semaglutide or liraglutide and suicidal or self-harming thoughts. The company ensures continuous monitoring of data from ongoing trials and real-world use of its products, collaborating closely with authorities to prioritize patient safety and provide healthcare professionals with adequate information.
The EMA’s investigation has the potential to reveal new side effects associated with drugs like Wegovy and Ozempic, which are already known to cause nausea, vomiting, and diarrhea. Currently, suicidal behavior is not listed as a side effect for any GLP-1 receptor agonists in the EU’s product information.
The prescribing information for Saxenda in the United States, approved by the Food and Drug Administration, does not list suicidal thoughts or self-injury as side effects. However, it does recommend monitoring patients for depression or suicidal thoughts and discontinuing the drug if symptoms arise. Clinical trials with Saxenda found that out of 3,300 participants, nine reported suicidal ideation compared to two in the placebo group. The prescribing information mentions that there was insufficient information to establish a causal relationship.
The U.S. prescribing information for Ozempic does not include a similar warning. In the case of Wegovy, the prescribing information notes that clinical trials for other weight management products have reported suicidal ideation and behavior. It advises physicians to monitor patients for depression and suicidal thoughts or behavior.
If you are experiencing suicidal thoughts, please contact the Suicide & Crisis Lifeline at 988 in the U.S. or the Samaritans at 116 123 in the U.K.
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