The European Medicines Agency (EMA) has concluded a nine-month investigation, finding no evidence linking a class of diabetes and weight-loss drugs to suicidal thoughts. This decisive statement by the EMA's Pharmacovigilance Risk Assessment Committee aims to reassure both patients and investors about the safety of these widely used medications.
Drugs such as Novo Nordisk's Wegovy and Ozempic, along with Eli Lilly's Mounjaro, fall under the GLP-1 receptor agonists category. Originally developed to manage blood sugar levels in diabetes patients, these medications have gained popularity for their effectiveness in weight management.
Following the EMA's announcement on Friday, shares of Danish pharmaceutical giant Novo Nordisk surged by over 2%, reflecting investor confidence in the company's flagship products. Novo Nordisk affirmed its commitment to continuously monitor any adverse drug reactions, including those related to mental health.
The investigation was prompted in July after Iceland's health regulator reported three instances of suicidal ideation among patients using these GLP-1 drugs. In response, the EMA sought additional data from drug manufacturers to thoroughly examine any potential risks.
After analyzing results from a significant U.S. study and another based on electronic health records, the EMA found no direct association between semaglutide—a key ingredient in Wegovy—and suicidal thoughts. Furthermore, the U.S. Food and Drug Administration (FDA) also published preliminary findings in January supporting the EMA's conclusion.
Dr. Robert Kushner, a professor at Northwestern University Feinberg School of Medicine, expressed relief over the findings, stating, \"I hope it's reassuring to patients and prescribers that after a thorough review by two regulatory agencies … there does not appear to be an increased risk of suicidal behavior.\" He also emphasized the importance of ongoing assessment by healthcare providers regarding patients' mental health.
While the EMA has closed its investigation, the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) continues to review the possible link between GLP-1 drugs and suicidal thoughts. Dr. Alison Cave, the MHRA's chief safety officer, indicated that the review is ongoing and that any further advice will be communicated to relevant stakeholders as needed.
Historically, concerns over the mental health effects of obesity drugs are not unfounded. In 2008, Sanofi's Acomplia was withdrawn in Europe due to its association with suicidal thoughts. However, current GLP-1 receptor agonists like Ozempic and Wegovy have demonstrated a relatively safe profile in clinical trials, with no significant suicide risks identified.
The EMA's latest findings also dispel earlier concerns about a potential link between GLP-1 drugs and thyroid cancer, as stated by the Pharmacovigilance Risk Assessment Committee in October.
As the use of these weight-loss medications continues to rise globally, regulatory bodies remain vigilant in ensuring their safety and efficacy, balancing the benefits of weight management against any potential risks to mental health.
Reference(s):
EU rules out link between weight-loss drugs and suicidal thoughts
cgtn.com
