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Gepubliceerd in: Journal of Child and Family Studies 4/2014

01-05-2014 | Original Paper

A Review of Recent FDA Drug Safety Communications for Pediatric Psychotropics

Auteurs: Thomas Kubiszyn, Sarah S. Mire

Gepubliceerd in: Journal of Child and Family Studies | Uitgave 4/2014

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Abstract

To alert professionals and consumers about safety risks associated with approved drugs, the U.S. Food and Drug Administration (FDA) periodically issues Drug Safety Communications, or DSCs (previously known as advisories, warnings, and health care professional letters). This review consolidates balanced information from 22 DSCs issued over the last 15 years by the FDA for drugs with pediatric indications (for any disorder) that are used to treat pediatric emotional and behavioral disorders (ADHD drugs, antipsychotics, antidepressants, and antiepileptics/anticonvulsants). A single-source document of pediatric DSCs for these drugs was needed because none existed previously; finding DSC information on the FDA website can be challenging; and other information sources (e.g., manufacturer or advocacy websites, blogs, other media reports) may lack the objectivity or accuracy that the FDA is charged to maintain. This consolidation is intended to enable better informed risk-benefit analysis around treatment selection and drug safety monitoring. For the 22 DSCs, we summarize the safety concerns, the populations affected, and when available from the FDA, the incidence of the adverse events, precursors, and factors that may increase or mitigate the risk of these very serious (e.g., sudden death, life-threatening rash, liver failure), but typically low incidence (<1 %) adverse events (cardiometabolic complications with atypical antipsychotics and suicidality with antidepressants are more common). This review does not address the far more common, but usually less serious, side effects that also accompany these drugs. Implications of this review for research and practice are discussed.
Literatuur
go back to reference American Diabetes Association, American Psychiatric Association; American Association of Clinical Endocrinologists, North American Association for the Study of Obesity. (2004). Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care, 27, 596–601. CrossRef American Diabetes Association, American Psychiatric Association; American Association of Clinical Endocrinologists, North American Association for the Study of Obesity. (2004). Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care, 27, 596–601. CrossRef
go back to reference Bazzano, A. T., Mangione-Smith, R., Schonlau, M., Suttorp, M. J., & Brook, R. H. (2009). Off-label prescribing to children in the United States outpatient setting. Academic Pediatrics, 9, 81–88. PubMedCrossRef Bazzano, A. T., Mangione-Smith, R., Schonlau, M., Suttorp, M. J., & Brook, R. H. (2009). Off-label prescribing to children in the United States outpatient setting. Academic Pediatrics, 9, 81–88. PubMedCrossRef
go back to reference Bridge, J. A., Greenhouse, J. B., Weldon, A. H., Campo, J. V., & Kelleher, K. J. (2008). Suicide trends among youths aged 10–19 years in the United States, 1996–2005. Journal of the American Medical Association, 300, 1025–1026. PubMedCrossRef Bridge, J. A., Greenhouse, J. B., Weldon, A. H., Campo, J. V., & Kelleher, K. J. (2008). Suicide trends among youths aged 10–19 years in the United States, 1996–2005. Journal of the American Medical Association, 300, 1025–1026. PubMedCrossRef
go back to reference Cobert, B. (2012). Cobert’s manual of drug safety and pharmacovigilance (2nd ed.). Sudbury, MA: Jones and Bartlett Learning. Cobert, B. (2012). Cobert’s manual of drug safety and pharmacovigilance (2nd ed.). Sudbury, MA: Jones and Bartlett Learning.
go back to reference Comer, J. S., Olfson, M., & Mojtabi, R. (2010). National trends in child and adolescent psychotropic polypharmacy in office-based practice, 1996–2007. Journal of the American Academy of Child and Adolescent Psychiatry, 49, 1001–1010. PubMedCentralPubMedCrossRef Comer, J. S., Olfson, M., & Mojtabi, R. (2010). National trends in child and adolescent psychotropic polypharmacy in office-based practice, 1996–2007. Journal of the American Academy of Child and Adolescent Psychiatry, 49, 1001–1010. PubMedCentralPubMedCrossRef
go back to reference Correll, C. V., Manu, P., Olshanskiy, V., Napolitano, B., Kane, J. M., & Malhotra, A. K. (2009). Cardiometabolic risk of second-generation antipsychotic medications during first-time use in children and adolescents. Journal of the American Medical Association, 302, 1765–1773. PubMedCentralPubMedCrossRef Correll, C. V., Manu, P., Olshanskiy, V., Napolitano, B., Kane, J. M., & Malhotra, A. K. (2009). Cardiometabolic risk of second-generation antipsychotic medications during first-time use in children and adolescents. Journal of the American Medical Association, 302, 1765–1773. PubMedCentralPubMedCrossRef
go back to reference Crystal, S., Olfson, M., Huang, C., Pincus, H., & Gerhard, T. (2009). Broadened use of atypical antipsychotics: Safety, effectiveness, and policy challenges. Health Affairs (Project Hope), 28(5), w770–w781. CrossRef Crystal, S., Olfson, M., Huang, C., Pincus, H., & Gerhard, T. (2009). Broadened use of atypical antipsychotics: Safety, effectiveness, and policy challenges. Health Affairs (Project Hope), 28(5), w770–w781. CrossRef
go back to reference Food and Drug Administration Amendments Act of 2007, Public Law 110-85 . See Title IX, Section 905. Food and Drug Administration Amendments Act of 2007, Public Law 110-85 . See Title IX, Section 905.
go back to reference Gibbons, R. D., Brown, C. H., Hur, K., Marcus, S. M., Bhaumik, D. K., Erkens, J. A., et al. (2007). Early evidence on the effects of regulators’ suicidality warnings on SSRI prescriptions and suicide in children and adolescents. American Journal of Psychiatry, 164, 1356–1363. PubMedCrossRef Gibbons, R. D., Brown, C. H., Hur, K., Marcus, S. M., Bhaumik, D. K., Erkens, J. A., et al. (2007). Early evidence on the effects of regulators’ suicidality warnings on SSRI prescriptions and suicide in children and adolescents. American Journal of Psychiatry, 164, 1356–1363. PubMedCrossRef
go back to reference Katz, L. Y., Kozyrskyj, A. L., Prior, H. J., Enns, M. W., Cox, B. J., & Sareen, J. (2008). Effect of regulatory warnings on antidepressant prescription rates, use of health services and outcomes among children, adolescents and young adults. Canadian Medical Association Journal, 178(8), 1005–1011. PubMedCentralPubMedCrossRef Katz, L. Y., Kozyrskyj, A. L., Prior, H. J., Enns, M. W., Cox, B. J., & Sareen, J. (2008). Effect of regulatory warnings on antidepressant prescription rates, use of health services and outcomes among children, adolescents and young adults. Canadian Medical Association Journal, 178(8), 1005–1011. PubMedCentralPubMedCrossRef
go back to reference Kubiszyn, T., Mire, S., Dutt, S., Papathopoulos, K., & Backsheider-Burridge, A. (2012). Significant differences in pediatric psychotropic side effects: Implications for school behavior and performance. School Psychology Quarterly, 27, 4–28. PubMedCrossRef Kubiszyn, T., Mire, S., Dutt, S., Papathopoulos, K., & Backsheider-Burridge, A. (2012). Significant differences in pediatric psychotropic side effects: Implications for school behavior and performance. School Psychology Quarterly, 27, 4–28. PubMedCrossRef
go back to reference Libby, A. M., Brent, D. A., Morrato, E. H., Orton, H. D., Allen, R., & Valuck, R. J. (2007). Decline in treatment of pediatric depression after FDA advisory on risk of suicidality with SSRIs. The American Journal of Psychiatry, 164, 884–891. PubMedCrossRef Libby, A. M., Brent, D. A., Morrato, E. H., Orton, H. D., Allen, R., & Valuck, R. J. (2007). Decline in treatment of pediatric depression after FDA advisory on risk of suicidality with SSRIs. The American Journal of Psychiatry, 164, 884–891. PubMedCrossRef
go back to reference Olfson, M., Blanco, C., Liu, L., Moreno, C., & Laje, G. (2006). National trends in the outpatient treatment of children and adolescents with antipsychotic drugs. Archives of General Psychiatry, 63, 679–685. PubMedCrossRef Olfson, M., Blanco, C., Liu, L., Moreno, C., & Laje, G. (2006). National trends in the outpatient treatment of children and adolescents with antipsychotic drugs. Archives of General Psychiatry, 63, 679–685. PubMedCrossRef
go back to reference Olfson, M., Crystal, S., Huang, C., & Gerhard, T. (2010). Trends in antipsychotic drug use by very young, privately insured children. Journal of the American Academy of Child and Adolescent Psychiatry, 49, 13–23. PubMed Olfson, M., Crystal, S., Huang, C., & Gerhard, T. (2010). Trends in antipsychotic drug use by very young, privately insured children. Journal of the American Academy of Child and Adolescent Psychiatry, 49, 13–23. PubMed
go back to reference Panagiotopoulos, C., Ronsley, R., Elbe, D., Davidson, J., & Smith, D. H. (2010). First do no harm: Promoting an evidence-based approach to atypical antipsychotic use in children and adolescents. Journal of the Canadian Academy of Child and Adolescent Psychiatry, 19, 124–137. PubMedCentralPubMed Panagiotopoulos, C., Ronsley, R., Elbe, D., Davidson, J., & Smith, D. H. (2010). First do no harm: Promoting an evidence-based approach to atypical antipsychotic use in children and adolescents. Journal of the Canadian Academy of Child and Adolescent Psychiatry, 19, 124–137. PubMedCentralPubMed
go back to reference Ray, W. A., Chung, C. P., Murray, K. T., Hall, K., & Stein, C. M. (2009). Atypical antipsychotic drugs and the risk of sudden cardiac death. New England Journal of Medicine, 360, 225–235. PubMedCentralPubMedCrossRef Ray, W. A., Chung, C. P., Murray, K. T., Hall, K., & Stein, C. M. (2009). Atypical antipsychotic drugs and the risk of sudden cardiac death. New England Journal of Medicine, 360, 225–235. PubMedCentralPubMedCrossRef
go back to reference Rudd, M. D., Cordero, L., & Bryan, C. J. (2009). What every psychologist should know about the Food and Drug Administration’s Black Box Warning label for antidepressants. Professional Psychology; Research and Practice, 40, 321–326. CrossRef Rudd, M. D., Cordero, L., & Bryan, C. J. (2009). What every psychologist should know about the Food and Drug Administration’s Black Box Warning label for antidepressants. Professional Psychology; Research and Practice, 40, 321–326. CrossRef
go back to reference Sammons, M. T. (2009). Writing a wrong: Factors influencing the overprescription of antidepressants to youth. Professional Psychology: Research and Practice, 40, 327–329. CrossRef Sammons, M. T. (2009). Writing a wrong: Factors influencing the overprescription of antidepressants to youth. Professional Psychology: Research and Practice, 40, 327–329. CrossRef
go back to reference Seida, J. C., Schouten, J. R., Boylan, K., Newton, K. S., Mousavi, S. S., Beaith, A., et al. (2012). Antipsychotics for children and young adults: A comparative effectiveness review. Pediatrics, 129, 2011–2058. CrossRef Seida, J. C., Schouten, J. R., Boylan, K., Newton, K. S., Mousavi, S. S., Beaith, A., et al. (2012). Antipsychotics for children and young adults: A comparative effectiveness review. Pediatrics, 129, 2011–2058. CrossRef
go back to reference Sikich, L., Hamer, R. M., Bashford, R. A., Sheitman, B. B., & Lieberman, J. A. (2004). A pilot study of risperidone, olanzapine, and haloperidol in psychotic youth: A double-blind, randomized, 8-week trial. Neuropsychopharmacology, 29, 133–145. PubMedCrossRef Sikich, L., Hamer, R. M., Bashford, R. A., Sheitman, B. B., & Lieberman, J. A. (2004). A pilot study of risperidone, olanzapine, and haloperidol in psychotic youth: A double-blind, randomized, 8-week trial. Neuropsychopharmacology, 29, 133–145. PubMedCrossRef
go back to reference Vitiello, B., Zuvekas, S. H., & Norquist, G. S. (2006). National estimates of antidepressant medication use among U. S. children. Journal of the American Academy of Child and Adolescent Psychiatry, 45, 271–279. PubMedCrossRef Vitiello, B., Zuvekas, S. H., & Norquist, G. S. (2006). National estimates of antidepressant medication use among U. S. children. Journal of the American Academy of Child and Adolescent Psychiatry, 45, 271–279. PubMedCrossRef
go back to reference Wilens, T. E., Prince, J. B., Spencer, T. J., & Biederman, J. (2006). Stimulants and sudden death: What’s a physician to do? Pediatrics, 118, 1215–1219. PubMedCrossRef Wilens, T. E., Prince, J. B., Spencer, T. J., & Biederman, J. (2006). Stimulants and sudden death: What’s a physician to do? Pediatrics, 118, 1215–1219. PubMedCrossRef
Metagegevens
Titel
A Review of Recent FDA Drug Safety Communications for Pediatric Psychotropics
Auteurs
Thomas Kubiszyn
Sarah S. Mire
Publicatiedatum
01-05-2014
Uitgeverij
Springer US
Gepubliceerd in
Journal of Child and Family Studies / Uitgave 4/2014
Print ISSN: 1062-1024
Elektronisch ISSN: 1573-2843
DOI
https://doi.org/10.1007/s10826-012-9706-x

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