EMA investigates Ozempic and different weight reduction medicine for threat of suicidal ideas
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The Pharmacovigilance Danger Evaluation Committee (PRAC) of the European Medicines Company (EMA) is reviewing information on the danger of suicidal ideas and ideas of self-harm with medicines generally known as GLP-1 receptor agonists, together with ‘Ozempic’ (semaglutide), ‘Saxenda’ (liraglutide) and ‘Wegovy’ (semaglutide), and are used for weight reduction and to deal with kind 2 diabetes.
The evaluation was initiated by the Icelandic Medicines Company following a number of stories of suicidal ideas and self-harm in folks utilizing medicines. liraglutide and semaglutide. Thus far, authorities have recovered and are analyzing round 150 stories of potential instances of self-harm and suicidal ideas.
The medicine liraglutide and semaglutide are broadly used, with an publicity of greater than 20 million sufferers a 12 months to this point. It's not but clear whether or not the reported instances are associated to the medicine themselves or to the sufferers’ underlying circumstances or different components.
The evaluation is carried out within the context of a chosen process. A sign is details about a brand new adversarial occasion probably brought on by a drugs or a drug. new side of a recognized adversarial occasion that warrants additional investigation. The presence of a sign doesn't essentially imply that a drug precipitated the adversarial occasion in query.
‘Saxenda’ and ‘Wegovy’ are licensed for the weight management, together with eating regimen and bodily exercise in overweight or obese folks within the presence of no less than one weight-related well being downside. ‘Ozempic’ is licensed for the remedy of adults with inadequately managed kind 2 diabetes as an adjunct to eating regimen and train, however has been used off-label for weight reduction.
The evaluation of Ozempic, Saxenda, and Wegovy started on July 3, 2023, and has now been expanded to incorporate different GLP-1 receptor agonists. This evaluation is predicted to conclude in November 2023. Suicidal habits will not be presently listed as a aspect impact within the EU product data for any GLP-1 receptor agonist.
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