The Spanish Agency for Medicines and Health Products (AEMPS) has joined the investigation that’s being carried out at a European stage on a attainable relationship between weight reduction medication akin to Ozempic, Saxenda and Wegoby with self-harm ideas in individuals who had been taking it . This has been confirmed to NIUS by the company below the Ministry of Health. The pharmacovigilance committee of the EMA (European Medicines Agency) is main this investigation after detecting in Iceland that three sufferers who had been taking medicine with these medication had suicidal ideas.
This similar Tuesday the EMA issued an alert and guaranteed that it’s reviewing the info on the chance of suicidal ideas and ideas of self-harm with medication often called GLP-1 receptor agonists, which embody ‘Ozempic’ (semaglutide), ‘Saxenda’ (liraglutide ) and ‘Wegovy’ (semaglutide), that are used for weight reduction and to deal with sort 2 diabetes.
The assessment was launched by the Icelandic medicines company following a number of reviews of suicidal ideas and self-harm in individuals utilizing the medicines liraglutide and semaglutide. So far, authorities have recovered and are analyzing round 150 reviews of attainable instances of self-harm and suicidal ideas.
The medication liraglutide and semaglutide are extensively used, with an publicity of greater than 20 million sufferers a 12 months up to now. It isn’t but clear whether or not the reported instances are associated to the medication themselves or to the sufferers’ underlying circumstances or different components.
The assessment is carried out within the context of a chosen process. A sign is details about a brand new hostile occasion probably brought on by a drug or a brand new side of a recognized hostile occasion that warrants additional investigation. The presence of a sign doesn’t essentially imply {that a} drug brought on the hostile occasion in query.
‘Saxenda’ and ‘Wegovy’ are licensed for weight management, together with food regimen and bodily exercise in obese or overweight people within the presence of at the least one weight-related well being downside. ‘Ozempic’ is licensed for the remedy of adults with inadequately managed sort 2 diabetes as an adjunct to food regimen and train, however has been used off-label for weight reduction.
The assessment of Ozempic, Saxenda, and Wegovy started on July 3, 2023, and has now been expanded to incorporate different GLP-1 receptor agonists. This assessment is anticipated to conclude in November 2023. Suicidal habits isn’t at the moment listed as a aspect impact within the EU product data for any GLP-1 receptor agonist.
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