The European Medicines Agency (EMA) is reviewing some weight-loss injections after receiving information that the injections were linked to suicidal thoughts and self-harm among users.
Iceland, a member state, notified the European Medicines Agency (EMA) after seeing three cases, with the EMA looking into Wegovy, Saxenda, and similar drugs — which help reduce a person’s appetite.
Although suicidal thoughts are listed as a possible side effect in product leaflets, suicidal behavior is not listed for “these prescription drugs.”
“The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which is conducting the review, will consider whether other treatments in the same broader category of medicines, glucagon-like peptide-1 (GLP-1) receptor agonists, also need assessing,” the British broadcaster reported.
Initially, the drug regulator will assess the risks of the medication that contains semaglutide or liraglutide.
“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 said.
“A signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation.
“The case reports included two cases of suicidal thoughts – one following the use of Saxenda and one after Ozempic.
“One additional case reported thoughts of self-injury with Saxenda.
“The EMA will communicate further when more information becomes available.”
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