The US Food and Drug Administration (FDA) says its preliminary review of reports related to suicidal thoughts or actions in patients treated with glucagon-like peptide-1 receptor agonists (GLP-1 RAs), has found no evidence linking the two.
The drugs are used to treat people with type 2 diabetes or to help those with obesity or who are overweight to shed kilos.
The agency said it has, over the past several months, conducted detailed evaluations of reports of suicidal thoughts or actions received in the FDA Adverse Event Reporting System (FAERS).
Because the information provided was often limited and because these events can be influenced by other potential factors, the FDA determined that the information in these reports did not demonstrate a clear relationship with the use of GLP-1 RAs.
Similarly, its reviews of the clinical trials, including large outcome studies and observational studies, found no association between use of GLP-1 RAs and the occurrence of suicidal thoughts or actions.
However, because of the small number of suicidal thoughts or actions observed in both people using GLP-1 RAs and in the comparative control groups, “we cannot definitively rule out that a small risk may exist; therefore, FDA is continuing to look into this issue”.
The agency said that healthcare professionals “should monitor for and advise patients using GLP-1 RAs to report new or worsening depression, suicidal thoughts, or any unusual changes in mood or behaviour”.
It recommended that the prescribing information be consulted when treating patients with these medications.
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UK reviews weight-loss drugs after ‘suicidal thoughts’