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The European Medicines Agency EMA is carrying out a review on the new weight-loss drugs and on a possible link with an increased risk of suicide, after receiving an alert from the Icelandic regulatory body regarding three possible cases. The start of the review was confirmed to several international media.
The EU agency explained that its Pharmacovigilance Committee (PRAC) will investigate the possible link with suicidal thoughts and self-harm by examining medicines that contain semaglutide or liraglutide, namely Wegovy*, Saxenda* and Ozempic*, reports the BBC online. Product inserts already list suicidal thoughts as a possible side effect. Suicidal behavior is not currently listed.
The Prac will consider whether other treatments in the same broader category of drugs, Glp-1 receptor agonists, should also be evaluated, but will initially focus on those based on semaglutide or liraglutide. “The review is being conducted in the context of a referral procedure raised by the Icelandic Medicines Agency, following three case reports,” an EMA official explained.
A safety signal, he recalled, is information about a new or known adverse event that is potentially caused by a medicine and requires further investigation. The case reports included two cases of suicidal thoughts: one after using Saxenda and one after Ozempic. For another case, thoughts of self-harm are reported after Saxenda. “The EMA – concluded the official – will communicate further when more information is available”.
In the limelight on social networks
These drugs have also gained media attention in the wake of numerous social media posts and stories of celebrities who have lost large amounts of weight using them. And there has recently been a boom in requests. In particular Ozempic – which contains semaglutide like Wegovy, but with a lower dosage, and is intended for people with diabetes to help them control blood sugar and weight – has come under the spotlight in recent months due to the problems of deficiency also generated by use misuse of the drug by non-diabetic people interested in losing weight. As for the drug manufacturer, Novo Nordisk, according to reports from the BBC, one of his representatives reiterated that the company has patient safety as a priority and is collaborating with the EMA: «Novo Nordisk continuously monitors data from clinical trials ongoing and real-world use of its products and works closely with authorities to ensure patient safety and adequate information to healthcare professionals.