The European Medicines Agency (EMA) started investigating the complications of diet drugs known as Ozempic and Saxenda on Monday after the Icelandic Medicines Agency said these appetite-reducing drugs could be linked to suicidal thoughts.
The EMA investigation into drugs like Ozempic, Saxenda and Wegovy was triggered after the Icelandic Medicines Agency sent a notification about new and possible complications.
While Saxenda promotes weight loss and contains the active ingredient liraglutide, Ozempic is approved for use in adults with inadequately controlled type 2 diabetes as an adjunct to diet and exercise.
“The review is being carried out in the context of a signal procedure raised by the Icelandic Medicines Agency, following three case reports.”, an EMA official told the press.
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which is conducting the review, will consider whether other treatments in the same broad class of medicines, glucagon-like peptide-1 (GLP-1) receptor agonists, also need to be assessed.
EMA’s investigation was triggered after the Icelandic Medicines Agency sent a tip about three cases. Two cases where people had suicidal thoughts while using Saxenda and Ozempic and one case of self-harming thoughts while using Saxenda.
“The European Medicines Agency will inform on the matter when the results are available,” the agency declared to the press.
Social media posts of people, often celebrities, losing large amounts of weight with these medicines have led to a high demand for this type of treatment.
Depression or suicidal thoughts are listed in the medicine leaflet, which advises users to be aware of any mental changes, especially sudden changes in the users’ mood, behaviour, thoughts or feelings.
If one of the incriminated medicines is deemed dangerous by the EMA, regulatory action such as suspension of marketing authorisation or withdrawal of the medicine from the market may be taken to ensure patient safety.
(Charles Szumski | EURACTIV.com)
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