Benzinga - by Vandana Singh, Benzinga Editor.
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has determined that there is no substantial evidence supporting a link between Glucagon-Like Peptide-1 receptor agonists (GLP-1) and suicidal or self-injurious thoughts and behaviors.
The assessment comes following reports of suicidal thoughts or actions. The FDA also conducted a review of GLP-1 RAs.
The FDA released an update stating that its preliminary review did not show definitive evidence that the drugs cause suicidal thoughts or actions.
GLP-1 receptor agonists, including dulaglutide, exenatide, liraglutide, lixisenatide, and semaglutide, are commonly prescribed for treating type 2 diabetes and, under specific conditions, for managing weight in obese or overweight adults.
The review was initiated in July 2023, prompted by reports of suicidal ideation among users of liraglutide and semaglutide medications.
In November 2023, the committee requested additional data from the marketing authorization holders for these medications, including Novo Nordisk A/S’s (NYSE:NVO) Ozempic, Rybelsus, Wegovy, Saxenda, Victoza, and Xultophy; AstraZeneca Plc’s (NASDAQ:AZN) Byetta and Bydureon; Sanofi SA’s (NASDAQ:SNY) Lyxumia, and Suliqua; and Eli Lilly And Co’s (NYSE:LLY) Trulicity.
Furthermore, the committee scrutinized the outcomes of a recent study based on a vast electronic health records database.
This study, which investigated the incidence of suicidal ideation in overweight patients with type 2 diabetes receiving semaglutide or other non-GLP-1 receptor agonist medications, found no direct link between semaglutide usage and suicidal thoughts.
The EMA conducted a study using electronic health records to investigate the risk of suicide and self-injury in people with type 2 diabetes using GLP-1 receptor agonists.
They found no evidence establishing a direct link between these medications and the mentioned risks.
Following a review of various data sources, including non-clinical studies, clinical trials, and post-marketing surveillance data, the PRAC concluded that no revision to the product information is necessary.
The PRAC determined that no changes to the product information are needed. The medication companies will continue monitoring these events and updating their safety reports accordingly.
Additionally, the PRAC approved a communication plan to inform healthcare professionals about differences between current and proposed formulations of Rybelsus, an oral semaglutide medication for poorly controlled type 2 diabetes.
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