The FDA warning on antidepressants and suicidality - Why the controversy?

New England Journal of Medicine

Volumn 371, Issue 18, 2014, Pages 1668-1671

  Stone, Marc B ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDEPRESSANT AGENT;

ADOLESCENT HEALTH; ADVERSE OUTCOME; AWARENESS; BOXED WARNING; CHILD HEALTH; DEPRESSION; DISEASE ASSOCIATION; DRUG INDICATION; DRUG INFORMATION; DRUG INTOXICATION; DRUG LABELING; DRUG MARKETING; DRUG USE; FOOD AND DRUG ADMINISTRATION; GEOGRAPHIC DISTRIBUTION; HUMAN; INCIDENCE; PRESCRIPTION; PREVALENCE; PUBLICATION; REVIEW; RISK REDUCTION; SOCIOECONOMICS; SUICIDE; SUICIDE ATTEMPT; TIME SERIES ANALYSIS; TREND STUDY; UNITED STATES; ADOLESCENT; ARTICLE; CHILD; DRUG UTILIZATION; GOVERNMENT REGULATION; INTOXICATION; LEGAL ASPECT; PSYCHOLOGICAL ASPECT; RISK FACTOR;

ADOLESCENT; ANTIDEPRESSIVE AGENTS; CHILD; DEPRESSIVE DISORDER; DRUG LABELING; DRUG UTILIZATION; GOVERNMENT REGULATION; HUMANS; POISONING; RISK FACTORS; SUICIDE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84908429011     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1411138     Document Type: Article

References (5)

1. Gibbons RD, Brown CH, Hur K, et al. Early evidence on the effects of regulators' suicidality warnings on SSRI prescriptions and suicide in children and adolescents. Am J Psychiatry 2007;164: 1356-63.
2. Valuck RJ, Libby AM, Orton HD, Morrato EH, Allen R, Baldessarini RJ. Spillover effects on treatment of adult depression in primary care after FDA advisory on risk of pediatric suicidality with SSRIs. Am J Psychiatry 2007; 164: 1198-205.
3. Libby AM, Orton HD, Valuck RJ. Persisting decline in depression treatment after FDA warnings. Arch Gen Psychiatry 2009; 66: 633-9.
4. Lu CY, Zhang F, Lakoma MD, et al. Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: Quasi-experimental study. BMJ 2014;348: G3596.
5. Schumock GT, Gibbons RD, Lee TA, Joo MJ, Valuck RJ, Stayner LT. Relationship between leukotriene-modifying agent prescriptions dispensed and rate of suicide deaths by county in the US. Drug Healthc Patient Saf 2011;3: 47-52.