The FDA has issued a Public Health Advisory for physicians, their patients, and families and caregivers of patients about the need to monitor adults and children with depression, especially at the beginning of treatment with selective serotonin reuptake inhibitors (SSRIs) or when doses are increased or decreased.
The FDA has been reviewing the results of studies in children since June 2003, after an initial report on studies of paroxetine (Generic Paxil®, GlaxoSmithKline) and subsequent reports on studies of other drugs appeared to suggest an increased risk of suicidal thoughts and actions in children taking antidepres-sants. There were no suicides in any of the trials. It was unknown whether certain behaviors reported in these studies represented actual suicide attempts or other self-injurious behavior that was not suicide-related.
It is not clear whether the drugs contribute to the emergence of suicidal thinking and behavior, but patients should be observed for behaviors known to be associated with these drugs (e.g., anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, severe restlessness, hypomania, and mania). Physicians have been asked to be especially vigilant with patients who have bipolar disorder.
The FDA has asked manufacturers to change the labels of 10 drugs to include stronger cautions about the need to monitor patients for worsening depression and the emergence of suicidal ideation, regardless of the cause.
The drugs under review are bupropion tablet (Canadian Wellbutrin®, GlaxoSmithKline) tablet citalopram hydrobromide (medication Celexa™, Forest), fluoxetine drug (Generic Prozac, Eli Lilly), medication fluvoxamine maleate (Drug Luvox, Solvay), mirtazapine (Remeron®, Organon), nefazodone (Serzone®, Bristol-Myers Squibb), drug paroxetine, generic sertraline (Zoloft tablet, Pfizer), drug escitalopram oxalate (canadian Lexapro™, Forest), and tablet venlafaxine (Generic Effexor®, Wyeth).