02
Aug
2023
02
Aug
2023
"The review is being carried out in the context of a signal procedure raised by the Icelandic Medicines Agency, following three case reports. A signal is an 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."
"GLP-1 receptor agonists have been used to treat type-2 diabetes for more than 15 years and for treatment of obesity for eight years, including Novo Nordisk products such as semaglutide and liraglutide that have been in the UK market since 2018 and 2009 respectively. The safety data collected from large clinical-trial programmes and post-marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and suicidal and self-harming thoughts. Novo Nordisk is continuously performing surveillance of the data from ongoing clinical trials and real-world use of its products and collaborates closely with the authorities to ensure patient safety and adequate information to healthcare professionals."
"As part of our close monitoring, any emerging evidence is routinely considered alongside other sources of information, including suspected adverse drug reactions. We will communicate any new advice to healthcare professionals and patients if appropriate. If you are experiencing suicidal thoughts or thoughts of self-harm, please seek immediate medical assistance. We ask everyone to report any suspected side effects using our Yellow Card scheme website."
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