FDA determines GLP-1s not linked to suicidal thoughts or actions in preliminary review

The FDA found that the use of GLP-1s to treat di­a­betes and obe­si­ty do not cause sui­ci­dal thoughts or ac­tions in a pre­lim­i­nary re­view of clin­i­cal tri­als and safe­ty da­ta re­port­ed to the agency.

The FDA has spent the past sev­er­al months eval­u­at­ing re­ports of sui­ci­dal thoughts and ac­tions re­port­ed via the agency’s ad­verse event re­port­ing sys­tem and de­ter­mined that the re­ports did not in­di­cate a clear con­nec­tion to the drugs, un­der­scor­ing that the da­ta pro­vid­ed are lim­it­ed and can be in­flu­enced by oth­er fac­tors. Sim­i­lar­ly, the agency’s re­view of clin­i­cal tri­als of GLP-1s did not find a link be­tween the drugs and sui­ci­dal thoughts and ac­tions.

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