The US Food and Drug Administration (FDA) has asked manufacturers to include a warning statement recommending close observation for worsening depression or the emergence of suicidality of adult and paediatric patients treated with the following antidepressants: fluoxetine (Prozac®); sertraline (Zoloft®); paroxetine (Paxil®); fluvoxamine (Luvox®); citalopram (Celexa®); escitalopram (Lexapro®); bupropion (Wellbutrin®); venlafaxine (Effexor®); nefazodone (Serzone®); and mirtazapine (Remeron®).

Warning Information

• Health care providers should carefully monitor patients receiving antidepressants for possible worsening of depression or suicidality, especially at the beginning of therapy or when the dose either increases or decreases.

• Heath care providers should carefully evaluate patients in whom depression persistently worsens, or emergent suicidality is severe, abrupt in onset, or was not part of the presenting symptoms, to determine what intervention, including discontinuing or modifying the current drug therapy, is indicated.

• There is concern that patients who experience symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania may be at increased risk for worsening depression or suicidality. Therefore, therapy should be evaluated and medications may need to be discontinued when symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

• If a decision is made to discontinue treatment, certain of these medications should be tapered rather than stopped abruptly.

• Patients should be adequately screened to determine if they are at risk for bipolar disorder before initiating antidepressant treatment.

Among antidepressants, only fluoxetine is approved for the treatment of paediatric major depressive disorder. Fluoxetine, sertraline, and fluvoxamine are approved for paediatric obsessive compulsive disorder. None of these drugs is approved as monotherapy for use in treating bipolar depression, either in adults or children.

Reference: FDA Public Health Advisory, 22 March 2004.