United States of America - The Food and Drug Administration (FDA) has cautioned health care professionals and patients about the need to closely monitor adults and children treated for depression following reports suggesting an increased risk of suicidal thoughts and actions in children given antidepressants.
FDA has initiated a full review and it is not yet clear whether antidepressants contribute to the emergence of suicidal thinking and behaviour. In the meantime, the agency is advising clinicians, patients, families and caregivers of adults and children that they should closely monitor all patients being placed on therapy with these drugs for worsening depression and suicidal thinking, which can occur during the early period of treatment.
The agency is also advising that these patients be observed for certain behaviours that are known to be associated with these drugs, such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania, and that physicians be particularly vigilant in patients who may have bipolar disorder.
The manufacturers of ten drugs will include stronger cautions and warnings about the need to monitor patients for the worsening of depression and the emergence of suicidal ideation, regardless of the cause of such worsening. The drugs under review include bupropion, citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, escitalopram and venlafaxine.
The only drug that has received approval for use in children with major depressive disorder is fluoxetine (Prozac®). Several of these drugs are approved for the treatment of obsessive-compulsive disorder in paediatric patients, i.e., sertraline (Zoloft®), fluoxetine (Prozac®), and fluvoxamine (Luvox®). Fluvoxamine is not approved as an antidepressant in the United States.
Reference: FDA Talk paper, T04-08. 22 March 2004.