The European Union’s drug regulator has concluded a nine-month investigation into the safety of a class of diabetes and weight-loss medications, finding no evidence of a link between these drugs and suicidal thoughts. This decision brings relief to patients and investors alike, particularly those in Asia where these medications are increasingly used.
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) announced on Friday that, after reviewing all available evidence, no updates are required to the product information of these treatments. The drugs in question include Novo Nordisk’s popular Wegovy and Ozempic, which contain the active ingredients semaglutide or liraglutide.
Novo Nordisk, a Danish pharmaceutical company, saw its shares rise by more than 2 percent following the EMA’s findings. “We welcome the conclusion of the EMA’s review,” the company stated, emphasizing their commitment to ongoing monitoring of adverse drug reactions, including any reports related to mental health.
The EMA’s investigation began in July after Iceland’s health regulator reported three cases of patients experiencing suicidal thoughts after using semaglutide-containing medications. The probe was extended in December to gather more data from drug manufacturers.
The EMA analyzed results from large-scale studies, including a significant U.S. study, and found no direct association between the use of these medications and suicidal thoughts. Similarly, the U.S. Food and Drug Administration’s preliminary review in January also found no link.
Dr. Robert Kushner, a professor at Northwestern University Feinberg School of Medicine, commented on the findings: “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.”
However, not all regulators have concluded their reviews. Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) continues to investigate the potential link. Dr. Alison Cave, the MHRA’s chief safety officer, noted that the review is ongoing and any further advice will be communicated as appropriate.
GLP-1 receptor agonists, the class of drugs under review, were originally developed to help control blood sugar levels in patients with diabetes. Medications like Ozempic, Wegovy, and Eli Lilly’s Mounjaro have since gained popularity for their effectiveness in weight management, a growing concern across Asia due to rising rates of obesity and diabetes.
The EMA’s findings are particularly significant for Asian markets, where access to effective weight-loss treatments is a priority for both healthcare providers and patients. The reassurance provided by the EU regulator may influence regulatory decisions and healthcare strategies in Asian countries.
As the global demand for effective weight management solutions grows, pharmaceutical companies and investors remain attentive to the safety profiles of these medications. The EMA’s conclusion helps alleviate concerns over potential mental health risks, paving the way for broader acceptance and utilization of these drugs in Asia and beyond.
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EU rules out link between weight-loss drugs and suicidal thoughts
cgtn.com
