Postmarketing surveillance of suicidal adverse events with pediatric use of antidepressants

Journal of Child and Adolescent Psychopharmacology

Volumn 16, Issue 1-2, 2006, Pages 33-36

  Mosholder, Andrew D ^a   Pamer, Carol A ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMFEBUTAMONE; ANTIDEPRESSANT AGENT; CITALOPRAM; ESCITALOPRAM; FLUOXETINE; FLUVOXAMINE; MIRTAZAPINE; NEFAZODONE; PAROXETINE; SEROTONIN UPTAKE INHIBITOR; SERTRALINE; VENLAFAXINE;

ADOLESCENT; ARTICLE; CHILD; CONSUMER; DATA ANALYSIS; DEPRESSION; DRUG USE; HEALTH CARE PERSONNEL; HUMAN; INFORMATION PROCESSING; POSTMARKETING SURVEILLANCE; SUICIDAL BEHAVIOR; SUICIDAL IDEATION;

ADOLESCENT; ADVERSE DRUG REACTION REPORTING SYSTEMS; ANTIDEPRESSIVE AGENTS; CHILD; HUMANS; MENTAL DISORDERS; PRODUCT SURVEILLANCE, POSTMARKETING; SUICIDE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33645815078     PISSN: 10445463     EISSN: None     Source Type: Journal    
DOI: 10.1089/cap.2006.16.33     Document Type: Article

References (8)

1. Ahmad SR: Adverse drug event monitoring at the Food and Drug Administration: Your report can make a difference. J Gen Intern Med 18:57-60; 2003.
2. Committee on Safety of Medicines: Selective serotonin reuptake inhibitors (SSRIs): Overview of regulatory status and CSM advice relating to major depressive disorder (MDD) in children and adolescents, including a summary of available safety and efficacy data. December 10, 2003. Online document at: medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages/ ssrioverview%5F101203.htm
3. Hartnell NR, Wilson JP, Patel NC, Crismon ML: Adverse event reporting with selective serotonin reuptake inhibitors. Ann Pharmacother 37:1387-1391, 2003.
4. King RA, Riddle MA, Chappell PB, Hardin MT, Anderson GM, Lombroso P, Scahill L: Emergence of self-destructive phenomena in children and adolescents during fluoxetine treatment. J Am Acad Child Adolesc Psychiatry 30:179-186, 1991.
5. Mosholder A: Office of Drug Safety data resources for the study of suicidal events associated with pediatric use of antidepressants. February 2, 2004. Online document at: www.fda.gov/ohrms/dockets/ac/04/slides/ 4006S1_06_Mosholder_files/frame.htm
6. Safer DJ, Zito JM, Gardner JF: Pemoline hepatotoxicity and postmarketing surveillance. J Am Acad Chud Adolesc Psychiatry 40:622-629, 2001.
7. Tiecher MH, Glod C, Cole JO: Emergence of intense suicidal preoccupation during fluoxetine treatment. Am J Psychiatry 147:207-210, 1990.
8. Weber JCP: Epidemiology of adverse reactions to nonsteroidal anti-inflammatory drugs. In: Advances in Inflammation Research, volume 6. Edited by Rainsford KD, Velo GP. New York, Raven Press, 1984, pp 1-7.