Antidepressant Prescriptions in Children Decrease Nearly 10 Percent after Black-Box Warnings; i3 Research Presents Findings at NCDEU.BASKING RIDGE, N.J. -- The number of pediatric patients prescribed an antidepressant decreased 9.8 percent after the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. issued black-box warnings in October 2004, according to a study being presented today by i3 Research at the National Institute of Mental Health's New Clinical Drug Evaluation Unit (NCDEU) annual meeting in Boca Raton. The study showed the number of patients receiving a selective serotonin reuptake inhibitor selective serotonin reuptake inhibitor n. SSRI. Selective serotonin reuptake inhibitor (SSRI) A class of antidepressants that work by blocking the reabsorption of serotonin in the brain, raising the levels of (SSRI SSRI selective serotonin reuptake inhibitor. SSRI n. Selective serotonin reuptake inhibitor; a class of drugs that inhibit the reuptake of serotonin in the central nervous system, used to treat depression and other ) or a serotonin-norepinephrine reuptake inhibitor serotonin-norepinephrine reuptake inhibitor Clinical pharmacology Any of a class of antidepressants–eg, venlafaxine, that block the reuptake of serotonin and norepinephrine (SNRI) decreased 11.9 percent. The FDA issued the black-box warning after a safety review indicated an increased risk of suicide among pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. antidepressant users. In order to determine the impact of this warning on antidepressant prescribing trends in the pediatric patient population, i3 Research examined de-identified health care claims data from a large U.S. health plan from one year before and for one year after the black-box warnings were issued. Of the 3.8 million eligible patients in the database, more than 62,000 patients ages 17 and younger were prescribed an antidepressant prior to the warning, mainly for a major depressive disorder Major depressive disorder A mood disorder characterized by profound feelings of sadness or despair. Mentioned in: Conduct Disorder major depressive disorder , while more than 56,000 were prescribed one after the warning. About half were ages 15 to 17, with a similar distribution of males and females overall. The greatest percentage decrease (14.5%) occurred in patients younger than 9 years. Poster Presentation 12-2 pm: A Review of Antidepressant Prescribing Practices in a Large, National, Managed Care Database of Pediatric Patients Prior to and After Black-Box Warnings About i3 i3, a global Ingenix company, provides integrated scientific strategies and solutions throughout the pharmaceutical product lifecycle. It is composed of i3 Research, a therapeutically specialized contract research organization; i3 Drug Safety, engaged in pharmacovigilence and epidemiology; i3 Statprobe, a leader in comprehensive data services; i3 Pharma Resourcing, a world-class staffing partner; i3 Innovus (formerly i3 Magnifi), delivering the science and solutions to achieve marketplace success; and, i3 DLN, providing continuing medical education continuing medical education See CME. . i3 helps companies gain sharper insights that lead to better patient care. For more information, visit www.i3global.com |
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