2023-07-11 18:45:00
There are “about 150” “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 they’re analyzing.” This was specified by the European Medicines Agency (EMA), in an official note on the review initiated by the Prac committee on these products.
The safety review of Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide) “began July 3 and was expanded to include other Glp-1 receptor agonists. The review is expected to conclude in November 2023,” the EU regulatory body.
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 products are “widely used, with an exposure of more than 20 million patient-years so far.”
The review, therefore, “is underway as part of a signaling 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.” Therefore, the EMA points out, “it is not yet clear whether the reported cases are linked to the drugs themselves, or to the patients’ underlying conditions or other factors”.
Saxenda and Wegovy are licensed for weight management, in conjunction with diet and physical activity, in obese or overweight people who have at least one weight-related health problem. Ozempic is licensed for 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.” In the EU, finally clarifies the EMA, “suicidal behavior is not currently listed as a side effect in the product information for any Glp-1 receptor agonist”.
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