Changes in US antidepressant and antipsychotic prescription patterns during a period of FDA actions

Pamer, Carol; Hammad, Tarek A.; Wu, Yue; Kaplan, Sigal; Rochester, G. D.; Governale, Laura; Mosholder, Andrew D.

doi:10.1002/pds.1886

Cited by 40 publications

(33 citation statements)

References 14 publications

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“…The interval between the initial warning (June 2003) and the formal black box warning (October 2004) was marked by media coverage on the risk of suicidality associated with pediatric antidepressant use (41). Consistent with prior research that describes decreases in antidepressant prescribing beginning before the 2004 warning (6, 7, 11, 14, 15), we observed a change in prescribing practices during this time. The change was most pronounced in children 13–17 years, where the proportion of patients initiating on low dose was stable during period 1 and then doubled after the paroxetine warning.…”

Section: Discussionsupporting

confidence: 89%

“…For example, following a 2005 black-box warning regarding the risk of atypical antipsychotic use among elderly patients with dementia, modest decreases in use were also seen among those without dementia (43). Comparatively, substantial decreases in antidepressant prescribing among children related to FDA communications (6, 7, 10, 14, 15, 18, 44, 45) were accompanied by modest decreases among adults (6, 14). …”

Section: Discussionmentioning

confidence: 95%

“…Following the black-box warning, antidepressant use overall decreased in youth,(6–16) paroxetine use decreased,(7, 11, 14) and fluoxetine use increased (11, 15). Other studies have documented shifted care from generalists to psychiatric specialists,(6, 8, 17) and a decrease in new pediatric depression diagnoses (9, 10).…”

Section: Introductionmentioning

confidence: 99%

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Dosing of Selective Serotonin Reuptake Inhibitors Among Children and Adults Before and After the FDA Black-Box Warning

Bushnell¹,

Stürmer²,

Swanson³

et al. 2016

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Objective Prior research evaluated various effects of the antidepressant black-box warning on the risk of suicidality in children, but the dosing of antidepressants has not been considered. This study estimated, relative to the FDA warnings, whether the initial antidepressant dose prescribed decreased and the proportion augmenting dose on the second fill increased. Method The study utilized the LifeLink Health Plan Claims Database. The study cohort consisted of commercially insured children (5–17 years), young adults (18–24 years), and adults (25–64 years) initiating an SSRI (citalopram, fluoxetine, paroxetine, or sertraline) from 1/1/2000 to 12/31/2009. Dose-per-day was determined by days supply, strength, and quantity dispensed. Initiation on low dose, defined based on guidelines, and dose augmentations (dose increase >1mg/day) on the second prescription were considered across time periods related to the antidepressant warnings. Results Of 51,948 children who initiated an SSRI, 15% initiated on low dose in the period before the 2004 black-box warning and 31% in the period after the warning (a 16 percentage-point change); there was a smaller percentage-point change in young adults (6%) and adults (3%). The overall increase in dose augmentations in children and young adults was driven by the increase in patients initiating on a low dose. Conclusions As guidelines recommend children initiate antidepressant treatment on low dose, findings that an increased proportion of commercially insured children initiated an SSRI on low dose after the 2004 black-box warning suggest prescribing practices surrounding SSRI dosing improved in children following the warning but dosing practices still fall short of guidelines.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 95%

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Dosing of Selective Serotonin Reuptake Inhibitors Among Children and Adults Before and After the FDA Black-Box Warning

Bushnell¹,

Stürmer²,

Swanson³

et al. 2016

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“…23 Our data do not reflect pediatric utilization in settings other than outpatient, such as inpatient or clinic settings, where seriously ill children are often treated. Data on OTC medications, herbals, and supplements, or on mail order prescriptions, were not included in this analysis.…”

Section: Approximatelymentioning

confidence: 99%

Trends of Outpatient Prescription Drug Utilization in US Children, 2002–2010

et al. 2012

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OBJECTIVE: To describe trends in outpatient prescription drug utilization in US children and the changes in major areas of pediatric therapeutic use for the years 2002 through 2010. METHODS: Large prescription databases (the IMS Vector One: National and Total Patient Tracker) were used to examine national drug utilization patterns for the US pediatric population (ages 0–17 years) from 2002 through 2010. RESULTS: In 2010, a total of 263.6 million prescriptions were dispensed to the US pediatric population, 7% lower than in 2002, while prescriptions dispensed to the adult population increased 22% during the same time. Analysis of pediatric drug utilization trends for the top 12 therapeutic areas in 2010 compared with 2002 showed decreases in systemic antibiotics (–14%), allergies (–61%), pain (–14%), depression (–5%), and cough/cold without expectorant (–42%) prescriptions, whereas asthma (14%), attention-deficit/hyperactivity disorder (46%), and contraceptive (93%) prescriptions increased. In 2010, amoxicillin was the most frequently dispensed prescription in infants (aged 0–23 months) and children (aged 2–11 years). Methylphenidate was the top prescription dispensed to adolescents (aged 12–17 years). Off-label use was identified, particularly for lansoprazole; ∼358 000 prescriptions were dispensed in 2010 for infants <1 year old. CONCLUSIONS: Changes in the patterns of pediatric drug utilization were observed from 2002 to 2010. Changes include a decrease in antibiotic use and an increase in attention-deficit/hyperactivity disorder medication use during the examined time. This article provides an overview of pediatric outpatient drug utilization, which could set the stage for further in-depth analyses.

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“…13,15 These increases have been mirrored by a dramatic rise in the use of neuropsychiatric drugs in children. [16][17][18] Antipsychotic use increased from 8.6 per 1000 children to 39.4 per 1000 children from 1995 to 2002, for example, and antidepressant use increased from 9.4 per 1000 to 21.3 per 1000 children between 1994 and 2003. [19][20][21] The lack of clinical evidence to support the use of these agents in children has resulted in a number of controversies, including concerns over increased suicidality among adolescents treated with selective serotonin reuptake inhibitors and of antipsychotic side effects in young children.…”

Section: Discussionmentioning

confidence: 99%

Analysis of Pediatric Clinical Drug Trials for Neuropsychiatric Conditions

2013

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BACKGROUND AND OBJECTIVE: Neuropsychiatric conditions represent a large and increasing disease burden in children. A number of drugs are available for the treatment of these conditions, but most drugs have not been adequately tested in children, and off-label drug use remains widespread. We sought to define and quantify recent and ongoing clinical research on the use of neuropsychiatric drugs in children. METHODS: Drug trials registered in ClinicalTrials.gov between 2006 and 2011 and studying neuropsychiatric conditions were selected and classified based on the drug’s Food and Drug Administration (FDA) approval status in children. We measured the proportion of trials seeking to expand the use of a drug to pediatric patients and the proportion of available drugs studied in children. RESULTS: Only 10% of neuropsychiatric trials focused on children. Of 303 drugs studied in both pediatric and adult populations, 90% lacked FDA approval in children and 97% were not approved in children for the indication studied. However, only 19% of all neuropsychiatric drugs were under study in pediatric populations, with as few as 8% of either antidepressant or antipsychotic drugs. Overall, 76% of pediatric drug trials examined a drug previously unapproved in children and 26% explored the use of a drug for a new indication. CONCLUSIONS: Despite the rising prevalence of neuropsychiatric disease and the paucity of FDA-approved pediatric drugs, only a small proportion of trials focus on pediatric populations and these trials cover only a fraction of available drugs. This deficiency is most pronounced for depression and schizophrenia.

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Changes in US antidepressant and antipsychotic prescription patterns during a period of FDA actions

Cited by 40 publications

References 14 publications

Dosing of Selective Serotonin Reuptake Inhibitors Among Children and Adults Before and After the FDA Black-Box Warning

Dosing of Selective Serotonin Reuptake Inhibitors Among Children and Adults Before and After the FDA Black-Box Warning

Trends of Outpatient Prescription Drug Utilization in US Children, 2002–2010

Analysis of Pediatric Clinical Drug Trials for Neuropsychiatric Conditions

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