EMA probe finds no causal link between semaglutide and suicidal thoughts, self-harm

The Eu­ro­pean Med­i­cines Agency found no link be­tween semaglu­tide use and sui­ci­dal thoughts or ac­tions, con­clud­ing a month­s­long probe that fol­lowed an in­quiry by the FDA that led to a sim­i­lar con­clu­sion last year.

The EMA’s Phar­ma­covig­i­lance Risk As­sess­ment Com­mit­tee (PRAC) be­gan look­ing last Ju­ly in­to re­ports of pa­tients tak­ing GLP-1s ex­pe­ri­enc­ing sui­ci­dal thoughts. Af­ter ex­am­in­ing sev­er­al stud­ies based on pa­tient health records, the group con­clud­ed that there was no need for the man­u­fac­tur­ers to take ac­tion on their safe­ty la­bel­ing.

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