The US FDA has revised its draft guidance on suicide risk in trials with updated terminology and expanded assessment criteria and has called for drug industry feedback.
Assessing suicides that occur during clinical trials has always been a part of research, but the process has become increasingly important in recent years after a number of meta-analyses linked higher suicides rates to certain patient groups and certain medications, notably antidepressants and antiepileptics.
The concern is that because the assessment of suicide risk is not usually the main focus of research, the occurrence of drug related suicides – or treatment-emergent suicidal ideation and behaviour to use the Food and Drug Administration’s (FDA) terminology – may have increased without being noticed.
To that end the FDA introduced its “Suicidality: Prospective Assessment of Occurrence in Clinical Trials” in September 2010 and – last week – the agency issued its latest revision of the document .
Key changes include the replacement of the term of suicidality with the phrase suicidal ideation and behavior and an expanded set of Columbia Classification Algorithm for Suicide Assessment (C-CASA) categories, along with definitions and explanations.
The FDA also stresses that current research suggests suicide assessments should be part of all trials of antidepressants and antiepileptic drugs, they should also be considered for other psychiatric disorders.
“There are no data to support the view that patients with nondepressed psychiatric disorders have any lesser vulnerability to treatment-induced suicidal ideation and behavior than patients with overt depression.
“On the contrary, based on limited exploratory analyses of the trials using antidepressants in adults, including many trials in psychiatric patients with disorders other than depression, there is some evidence that the relative risk may actually be greater in nondepressed psychiatric patients.”