Possible link between some weight loss drugs and an increased risk of suicide. L’Ema (European Medicines Agency) is conducting a review, after receiving an alert from the Icelandic regulatory body relating to three possible cases. The EU agency explained that its pharmacovigilance committee (Prac) will investigate the possible link with suicidal thoughts and self-harm by examining medications that contain semaglutide or liraglutide, i.e. Wegs, Saxenda e Ozempic.
FURTHER INFORMATION
Semaglutide, the anti-diabetic drug sold without a prescription and used to lose weight. Aifa alert: “Shortness for the whole of 2023”
The review “began on July 3 and was expanded to include other Glp-1 receptor agonists. The review should be completed in November 2023,” predicts the EU regulatory body. I am “circa 150» the «reports of possible cases of self-harm and suicidal thoughts» in people using medicines based on liraglutide and semaglutide – used for weight loss and the treatment of type 2 diabetes – which «the authorities have recovered and are analyzing» .
Revision
The review – explains the EMA – was initiated by the Icelandic Medicines Agency after reports of suicidal thoughts and self-harm in people who use medicines based on liraglutide and semaglutide. These are products “widely used, with an exposure of more than 20 million patient-years so far”. The review, therefore, “is underway as part of a reporting procedure. A signal – recalls the European regulatory body – is information on a new adverse event potentially caused by a drug, or on a new aspect of a known adverse event, which requires further investigation. The presence of a signal does not necessarily mean that a medicinal product caused the adverse event in question.”
The link
Therefore, the EMA points out, “it is not yet clear whether the reported cases are connected to the drugs themselves, or to the patients’ basic conditions or to other factors”. Saxenda and Wegovy are licensed for weight management, in conjunction with diet and physical activity, in obese or overweight people with at least one weight-related health problem. Ozempic is licensed for the treatment of adults with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise, but has been used off-label for weight loss. Finally, in the EU, EMA clarifies, “suicidal behavior is not currently listed as a side effect in the product information for any Glp-1 receptor agonist”.
Drugs
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.