Effects of FDA Advisories on the Pharmacologic Treatment of ADHD, 2004-2008
ABSTRACT OBJECTIVE: This study assessed the effect of public health advisories issued between 2005 and 2007 by the U.S. Food and Drug Administration (FDA) on treatments of attention-deficit hyperactivity disorder (ADHD) and physician prescribing practices. METHODS: Data obtained from the IMS Health National Disease and Therapeutic Index, a nationally representative audit of ambulatory physicians, were used to examine trends in office visits by children and adolescents (under age 18) during which ADHD was treated with Adderall, other psychostimulants, or atomoxetine. Segmented time series regressions were conducted to determine changes in use associated with three advisories issued between 2005 and 2007. RESULTS: In 2004, before the first FDA advisory, Adderall accounted for 36% of ADHD pharmacotherapy treatment visits. Other stimulants accounted for 46%, and atomoxetine accounted for 19%. Overall pharmacotherapy treatment rates were stable over the study period, but by 2008 the treatment visits accounted for by Adderall (that is, market share) declined to 24%, and the market share for atomoxetine declined to 8%. The market share for substitute therapies-clonidine, guanfacine, and bupropion-was stable over this period, ranging from 5% to 7%. Despite the declines in the use of Adderall and atomoxetine over the study period, results from the regression models suggest that the advisories did not have a statistically significant effect on ADHD medication prescribing. CONCLUSIONS: FDA advisories regarding potential cardiovascular and other risks of ADHD medications had little discernible incremental effect on the use of these medicines in this nationally representative ambulatory audit.
- SourceAvailable from: Tanya E Froehlich[Show abstract] [Hide abstract]
ABSTRACT: OBJECTIVE:To examine recent national trends in psychotropic use for very young children at US outpatient medical visits.METHODS:Data for 2- to 5-year-old children (N = 43 598) from the 1994-2009 National Ambulatory and National Hospital Ambulatory Medical Care Surveys were used to estimate the weighted percentage of visits with psychotropic prescriptions. Multivariable logistic regression was used to identify factors associated with psychotropic use. Time effects were examined in 4-year blocks (1994-1997, 1998-2001, 2002-2005, and 2006-2009).RESULTS:Psychotropic prescription rates were 0.98% from 1994-1997, 0.83% from 1998-2001, 1.45% from 2002-2005, and 1.00% from 2006-2009. The likelihood of preschool psychotropic use was highest in 2002-2005 (1994-1997 adjusted odds ratio [AOR] versus 2002-2005: 0.67; 1998-2001 AOR versus 2002-2005: 0.63; 2006-2009 AOR versus 2002-2005: 0.64), then diminished such that the 2006-2009 probability of use did not differ from 1994-1997 or from 1998-2001. Boys (AOR versus girls: 1.64), white children (AOR versus other race: 1.42), older children (AOR for 4 to 5 vs 2 to 3 year olds: 3.87), and those lacking private insurance (AOR versus privately insured: 2.38) were more likely than children from other groups to receive psychotropic prescriptions.CONCLUSIONS:Psychotropic prescription was notable for peak usage in 2002-2005 and sociodemographic disparities in use. Further study is needed to discern why psychotropic use in very young children stabilized in 2006-2009, as well as reasons for increased use in boys, white children, and those lacking private health insurance.PEDIATRICS 09/2013; 132(4). DOI:10.1542/peds.2013-1546 · 5.30 Impact Factor
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ABSTRACT: The Black Box Warning (BBW) is the Food and Drug Administration's highest level of drug warning. It signifies that a medication has serious (or potentially life-threatening) side effects and is prominently displayed on a medication's package insert. It literally consists of the medication warning and is surrounded by a bold black border. This article aims to review data related to BBWs on psychotropic medications currently used in clinical practice, with special attention to clinical situations and questions relevant to consultation-liaison psychiatrists. We review 3 clinical advisories or BBWs for psychotropic medications (i.e., antidepressant medication and suicidality in the pediatric population, stimulant medication and sudden death in the pediatric population, and antipsychotic medication and increased mortality in the elderly) and discuss the effect they have had on prescribing practices. We provide a table of current BBWs relevant to psychotropic medications. BBWs can have unintended and far-reaching consequences, albeit with a limited ability to target specific populations and practice patterns. Although it is critical for clinicians to be aware of these serious potential side effects and to inform patients about these warnings, medications with boxed warnings remain Food and Drug Administration-approved and may have critically important therapeutic roles.Psychosomatics 12/2013; DOI:10.1016/j.psym.2013.08.009 · 1.67 Impact Factor
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ABSTRACT: Data from the 2003 and 2007 National Survey of Children's Health (NSCH) reflect the increasing prevalence of parent-reported attention-deficit/hyperactivity disorder (ADHD) diagnosis and treatment by health care providers. This report updates these prevalence estimates for 2011 and describes temporal trends. Weighted analyses were conducted with 2011 NSCH data to estimate prevalence of parent-reported ADHD diagnosis, current ADHD, current medication treatment, ADHD severity, and mean age of diagnosis for U.S. children/adolescents aged 4 to 17 years and among demographic subgroups. A history of ADHD diagnosis (2003-2011), as well as current ADHD and medication treatment prevalence (2007-2011), were compared using prevalence ratios and 95% confidence intervals. In 2011, 11% of children/adolescents aged 4 to 17 years had ever received an ADHD diagnosis (6.4 million children). Among those with a history of ADHD diagnosis, 83% were reported as currently having ADHD (8.8%); 69% of children with current ADHD were taking medication for ADHD (6.1%, 3.5 million children). A parent-reported history of ADHD increased by 42% from 2003 to 2011. Prevalence of a history of ADHD, current ADHD, medicated ADHD, and moderate/severe ADHD increased significantly from 2007 estimates. Prevalence of medicated ADHD increased by 28% from 2007 to 2011. Approximately 2 million more U.S. children/adolescents aged 4 to 17 years had been diagnosed with ADHD in 2011, compared to 2003. More than two-thirds of those with current ADHD were taking medication for treatment in 2011. This suggests an increasing burden of ADHD on the U.S. health care system. Efforts to further understand ADHD diagnostic and treatment patterns are warranted.Journal of the American Academy of Child and Adolescent Psychiatry 01/2014; 53(1):34-46.e2. DOI:10.1016/j.jaac.2013.09.001 · 6.35 Impact Factor