Why the FDA Issued a Black Box Warning Against the Use of Antidepressants in Children and Adolescents In 2004
Depression is a disorder that leads to serious problems in behavior thinking, and moods either at home or with peers. However, the disease is treatable mainly among children and adolescents using antidepressant medication. Following the increased concerns by the united states food and drug administration that the use of the antidepressants medications may increase the risk of suicidal behavior and thought among the children and adolescents treated with the antidepressant drug, the FDA administration decided to issue a black box against the antidepressant drug (Friedman, 2014). The black box warning which is considered to be the most severe type of warning in the prescription drug labeling
What Did The Evidence For This Warning Consist Of?
The evidence that lead to the food and drug administration issuing a black box warning against the drug is the result obtained from a research that found out that the rate of suicidal behavior or thinking among the children and adolescents was at approximately 4% among the patients that received the antidepressant medication compared to the 2% that receive the placebo medication (Friedman, 2014). The finding also found out that the increased risks of suicidal behavior were mainly among the adolescents and children under the antidepressant medication.
Criticism Of Both The Methodology Of Studies And Risks Inherent With Untreated Depression
The method used by the food and drug administration to initiate the black box is considered to raised concerns or debates. The debate was because of other researchers claiming that it is extremely difficult to tell whether the antidepressant medications increase the risk of suicide among the children and adolescents. This is because most of the controlled trials tend to be too small to identify the rare events such as suicide among the huge number of participants (Stone, 2014). The trials also tend to eliminate those patients who are considered to be at high risk of suicide. Therefore, these views by other researchers brought about huge contradiction against the food and drug administration to black box the use of antidepressants among the children.
Which Antidepressant Is FDA Approved For Children?
The fluoxetine is considered the only approved medication for treatment of depression mainly among the children aged above eight years. Despite fluoxetine being helpful in the treatment of childhood depression, it also leads to huge improvement of the overall depression. On the other hand, the drug is considered to enhance the risk of suicidal thought and behavior among a certain portion of adolescent (Stone, 2014). In most cases, the families and doctors tend to weigh the benefits and risks of the drugs before the treatment of each patient.
What Are Other Commonly Used Off-Label Medications For Depression?
Off-label, medication refers to the use of other potentially effective treatment that has not been approved by the respective regulatory agencies such as the United States food and drug administration to treat depression (Cheung et al.2008). the off-label medication used in depression treatment include some of the SSRI medications and SSRI related antidepressants that for example the venlafaxine which has not been approved for use by the food and drug administration but the doctors use it to treat the depressed the children and adolescents in an off-label basis.
Besides Pharmacological Interventions, What Evidence-Based Interventions Are Used For The Treatment Of Depression In Children And Adolescents?
There are various evidence-based interventions that are used for the treatment of depression for both the children and adolescents. Some of these interventions include, first, screening which is also referred to as psychotherapy. Screening helps to determine the level of severity of the depression, the severity of the disease and to check whether the patient should receive the antidepressant prescription. An example of psychotherapy includes cognitive behavior therapy (Weisz et al. 2006). Secondly, assessment to confirm the diagnosis. Frequent evaluation after positive screening should be initiated among adolescents or children to help determine the presence of depression and other environmental stressors.
Thirdly, brief supportive counseling. Thus, the type of counseling is recommended for the children and the adolescents experiencing mild depression symptoms. The counseling is made up of eight sessions of supportive therapy. Fourth, treatment, the level of severity tends to be the key determinant of whether to initiate treatment to the patient experiencing depression (Birmaher et al. 2007). Prescription of the antidepressant is made when the level of depression is severe. In most cases the evidence-based intervention tends to be more effective as compared to the pharmacological interventions, this is because the evidence-based interventions are considered to be more detailed and involve a series of steps that are aimed at tackling the disease as compared to the pharmacological intervention that involves just giving prescriptions with no follow-up.
References
Birmaher, B., Brent, D., & AACAP Work Group on Quality Issues. (2007). Practice parameter for the assessment and treatment of children and adolescents with depressive disorders. Journal of the American Academy of Child & Adolescent Psychiatry, 46(11), 1503-1526.
Cheung, A., Sacks, D., Dewa, C. S., Pong, J., & Levitt, A. (2008). Pediatric prescribing practices and the FDA black-box warning on antidepressants. Journal of Developmental & Behavioral Pediatrics, 29(3), 213-215.
Friedman, R. A. (2014). Antidepressants' black-box warning-10 years later. New England Journal of Medicine, 371(18), 1666-1668.
Weisz, J. R., McCarty, C. A., & Valeri, S. M. (2006). Effects of psychotherapy for depression in children and adolescents: a meta-analysis. Psychological Bulletin, 132(1), 132.
Stone, M. B. (2014). The FDA warning on antidepressants and suicidality-why the controversy?. New England Journal of Medicine, 371(18), 1668-1671.
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