The U cheer and Drug Administratio...

The U cheer and Drug Administration (FDA) has issued a Public Health Advisory that provides further cautions to physicians, their patients, and families and caregivers of patients about the ne to closely monitor adults and children with depression, especially at the beginning of pharmacotherapy, or when the doses of antidepressants are changed with an increase or decrease in the dose. The Public Health Advisory containing novel label warnings and cautions is available online at: http://www.fda. gov/cder/drug/antidepressants/ default.htm.

The FDA has been closely reviewing the comes of antidepressant studies in children since June 2003 after an initial report in succession studies with paroxetine (Paxil), and posterior reports on studies of other remedys appeared to suggest an increased risk of suicidal cogitations and actions in the children given antidepressants. There were no suicides reported in any of the trials. onward close examination of the initial reports, it was unclear whether certain behaviors reported in these studies delineateed actual suicide attempts, or other self-injurious behavior that was not suicide-related.

The FDA has initiated a replete review of these reported behaviors by way of experts in such evaluation. However, it is not over and above clear whether antidepressants contribute to the emerging see the verb of suicidal thinking and behavior. The agency is advising physicians, patients, families, and caregivers of adults and children that they should closely monitor all patients being placed upon therapy with these drugs for worsening depression and suicidal thinking, which can arise during the early period of treatment. The agency also is advising that these patients be observ for certain behaviors that are known to be associated with these physics such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness) hypomania, and mania, and that physicians be particularly vigilant of patients who may have bipolar disorder.

The medicines under review include bupropion (Wellbutrin), citalopram (Celexa), fluoxetine (Prozac), fluvoxamine (Luvox) mirtazapine (Remeron) nefazodone (Serzone) paroxetine (Paxil), sertraline (Zoloft) escitalopram (Lexapro), and venlafaxine (Effexor). The merely drug that has received approval for use in children with major depressive disorder is fluoxetine. Several of these put drugs intos are approved for the treatment of obsessive-compulsive disorder in pediatric patients (i.e., sertraline, fluoxetine, and fluvoxamine). Fluvoxamine is not approved as an antidepressant in the United States.

COPYRIGHT 2004 American Academy of Family Physicians

COPYRIGHT 2004 Gale Group