Unapproved uses of approved drugs: the physician, the package insert, and the Food and Drug Administration: subject review. American Academy of Pediatrics Committee on Drugs.

Abstract:

:Physicians who prescribe a new drug that has not been approved for a specific indication or a specific age group frequently find themselves in a quandary. Physicians who prescribe "old," time-honored drugs usually do not consult the package insert or search for US Food and Drug Administration (FDA) approval. This statement was written to clarify the legal and informational status of the package insert and the role of the FDA in approving or not approving drugs for specific indications or specific age groups. The unapproved use of approved drugs, or so-called "off-label" use, is extremely prevalent among physicians who care for children. It is important that such use of compounds be brought up to date with current FDA policies and to emphasize the responsibility of the prescribing physician in the use of these compounds.

journal_name

Pediatrics

journal_title

Pediatrics

authors

subject

Has Abstract

pub_date

1996-07-01 00:00:00

pages

143-5

issue

1

eissn

0031-4005

issn

1098-4275

journal_volume

98

pub_type

杂志文章,评审
  • Infant sleep position: pediatricians' advice to parents.

    abstract:OBJECTIVE:The American Academy of Pediatrics' (AAP) recommendation for side or supine sleep position in healthy babies has generated much controversy. We surveyed primary care physicians to determine the effect of the AAP statement on physician attitude toward infant sleep position and advice to parents. METHODS:We se...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: Hudak BB,O'Donnell J,Mazyrka N

    更新日期:1995-01-01 00:00:00

  • Sweat chloride concentrations in infants homozygous or heterozygous for F508 cystic fibrosis.

    abstract:OBJECTIVE:To determine whether an adequate volume of sweat could be obtained routinely from infants younger than 6 weeks old and to evaluate sweat chloride levels in infants with known genotype statuses, including heterozygote carriers for cystic fibrosis (CF). METHODOLOGY:Infants were evaluated using pilocarpine iont...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: Farrell PM,Koscik RE

    更新日期:1996-04-01 00:00:00

  • Antibiotic Stewardship in Pediatrics.

    abstract::Antibiotic overuse contributes to antibiotic resistance, which is a threat to public health. Antibiotic stewardship is a practice dedicated to prescribing antibiotics only when necessary and, when antibiotics are considered necessary, promoting use of the appropriate agent(s), dose, duration, and route of therapy to o...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2020-040295

    authors: Gerber JS,Jackson MA,Tamma PD,Zaoutis TE,COMMITTEE ON INFECTIOUS DISEASES, PEDIATRIC INFECTIOUS DISEASES SOCIETY.

    更新日期:2021-01-01 00:00:00

  • Skin lesions in a boy with X-linked lymphoproliferative disorder: comparison of 5 SH2D1A deletion cases.

    abstract::SH2D1A gene defects are the cause of X-linked lymphoproliferative disorder (XLP-1), a rare condition characterized by severe immune dysregulation. We present a patient lacking the typical symptoms of XLP-1, but experiencing a severe unusual skin condition encompassing features of dermatosclerosis and vesiculobullous s...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2011-0870

    authors: Mejstríková E,Janda A,Hrusák O,Bucková H,Vlcková M,Hancárová M,Freiberger T,Ravcuková B,Vesely K,Fajkusová L,Kopecková L,Sumerauer D,Kabícková E,Sedivá A,Stary J,Sedlácek Z

    更新日期:2012-02-01 00:00:00

  • Nebulized hypertonic saline without adjunctive bronchodilators for children with bronchiolitis.

    abstract:OBJECTIVE:The goal was to determine an adverse event rate for nebulized hypertonic saline solution administered without adjunctive bronchodilators for infants with bronchiolitis. METHODS:This was a retrospective cohort study of the use of nebulized 3% saline for children<2 years of age who were hospitalized with the p...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2009-3105

    authors: Ralston S,Hill V,Martinez M

    更新日期:2010-09-01 00:00:00

  • Evidence from proton magnetic resonance spectroscopy for a metabolic cascade of neuronal damage in shaken baby syndrome.

    abstract:OBJECTIVE:The purpose of this study was to use proton magnetic resonance spectroscopy (MRS) as a metabolic assay to describe biochemical changes during the evolution of neuronal injury in infants after shaken baby syndrome (SBS), that explain the disparity between apparent physical injury and the neurological deficit a...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.99.1.4

    authors: Haseler LJ,Arcinue E,Danielsen ER,Bluml S,Ross BD

    更新日期:1997-01-01 00:00:00

  • Pediatric cardiac surgery: the effect of hospital and surgeon volume on in-hospital mortality.

    abstract:OBJECTIVE:To examine the relationship between annual provider (hospital and surgeon) volume of pediatric cardiac surgery and in-hospital mortality. DESIGN:Population-based retrospective cohort study using a clinical database. SETTING:The 16 acute care hospitals in New York with certificate of need approval to perform...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.101.6.963

    authors: Hannan EL,Racz M,Kavey RE,Quaegebeur JM,Williams R

    更新日期:1998-06-01 00:00:00

  • Evaluation of airway complications in high-risk preterm infants: application of flexible fiberoptic airway endoscopy.

    abstract:OBJECTIVES:We sought to determine factors that would predict the development of subglottic stenosis (SGS) and tracheomalacia (TM) in preterm infants. The utility of a semiquantitative measurement of airway dimensions was assessed in relation to signs of airway complications. We also sought to determine from a high-risk...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: Downing GJ,Kilbride HW

    更新日期:1995-04-01 00:00:00

  • Acquired immunodeficiency syndrome transmission: changes in knowledge and behaviors among teenagers, Massachusetts statewide surveys, 1986 to 1988.

    abstract::Despite substantial progress, adolescents remain at high risk for human immunodeficiency virus (HIV) infection. Two independent random digit dial statewide Massachusetts surveys of 16- to 19-year-old persons conducted August through September 1986 and 1988 revealed that the proportion of teenagers who had discussed ac...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: Hingson R,Strunin L,Berlin B

    更新日期:1990-01-01 00:00:00

  • Influenza burden for children with asthma.

    abstract:OBJECTIVE:The goal was to estimate the influenza disease burden among children with asthma and among healthy children by using active, laboratory-confirmed, population-based surveillance. METHODS:Children 6 to 59 months of age residing in 3 US counties who were hospitalized with acute respiratory illnesses or fever we...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2007-1053

    authors: Miller EK,Griffin MR,Edwards KM,Weinberg GA,Szilagyi PG,Staat MA,Iwane MK,Zhu Y,Hall CB,Fairbrother G,Seither R,Erdman D,Lu P,Poehling KA,New Vaccine Surveillance Network.

    更新日期:2008-01-01 00:00:00

  • Factors Associated With HIV Testing in Teenage Men Who Have Sex With Men.

    abstract:BACKGROUND:Adolescent men who have sex with men (AMSM) have a high rate of HIV diagnoses. An estimated 14.5% of HIV infections in the United States are undiagnosed; but among 13- to 24-year-olds, the rate is 51.4%. We describe HIV testing rates and identifies salient individual, family, school, and health care influenc...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2019-2322

    authors: Mustanski B,Moskowitz DA,Moran KO,Rendina HJ,Newcomb ME,Macapagal K

    更新日期:2020-03-01 00:00:00

  • Improving early literacy promotion: a quality-improvement project for Reach Out and Read.

    abstract:BACKGROUND:The Reach Out and Read (ROR) program promotes early literacy as part of pediatric primary care through the distribution of children's books and anticipatory guidance during early childhood. OBJECTIVES:To improve the rates of age-appropriate book-giving during well-child care and the delivery of ROR-recommen...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2010-2290

    authors: Khandekar AA,Augustyn M,Sanders L,Zuckerman B

    更新日期:2011-04-01 00:00:00

  • Growth of hyperkinetic children taking methylphenidate, dextroamphetamine, or imipramine/desipramine.

    abstract::One hundred children with the hyperkinetic syndrome or minimal brain dysfunction syndrome were treated with medication: 60 with methylphenidate (Ritalin), 24 with dextroamphetamine (Dexedrine), and 16 with either imipramine or desipramine. The duration of treatment was for a minimum of two years, and averaged five yea...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: Gross MD

    更新日期:1976-09-01 00:00:00

  • Bladder retention of urine as a result of continuous intravenous infusion of fentanyl: 2 case reports.

    abstract::Sedation has been commonly used in the neonate to decrease the stress and pain from the noxious stimuli and invasive procedures in the neonatal intensive care unit, as well as to facilitate synchrony between ventilator and spontaneous breaths. Fentanyl, an opioid analgesic, is frequently used in the neonatal intensive...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.108.4.1012

    authors: Das UG,Sasidharan P

    更新日期:2001-10-01 00:00:00

  • Outbreak of Mycoplasma pneumoniae-Associated Stevens-Johnson Syndrome.

    abstract:BACKGROUND:Stevens-Johnson syndrome (SJS) is an uncommon, sporadic disease and outbreaks are rare. In November 2013, an outbreak of SJS was identified at Children's Hospital Colorado. METHODS:Outbreak cases were children aged 5-21 with a discharge diagnosis of SJS admitted from September 1 to November 30, 2013. Medica...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2015-0278

    authors: Olson D,Watkins LK,Demirjian A,Lin X,Robinson CC,Pretty K,Benitez AJ,Winchell JM,Diaz MH,Miller LA,Foo TA,Mason MD,Lauper UL,Kupfer O,Kennedy J,Glodé MP,Kutty PK,Dominguez SR

    更新日期:2015-08-01 00:00:00

  • Less aggressive treatment of neonatal jaundice and reports of kernicterus: lessons about practice guidelines.

    abstract::The publication of guidelines calling for less aggressive treatment of jaundice in newborns has been followed by a reappearance of case reports of kernicterus. These case reports illustrate important issues for writers and consumers of practice guidelines. One issue is the particular salience of identified patients wi...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: Newman TB,Maisels MJ

    更新日期:2000-01-01 00:00:00

  • Prenatal di(2-ethylhexyl)phthalate exposure and length of gestation among an inner-city cohort.

    abstract:OBJECTIVE:Our objective was to assess the relationship between di(2-ethylhexyl)phthalate (DEHP) exposure during pregnancy and gestational age at delivery among 311 African American or Dominican women from New York City. METHODS:Forty-eight-hour personal air and/or spot urine samples were collected during the third tri...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2009-0325

    authors: Whyatt RM,Adibi JJ,Calafat AM,Camann DE,Rauh V,Bhat HK,Perera FP,Andrews H,Just AC,Hoepner L,Tang D,Hauser R

    更新日期:2009-12-01 00:00:00

  • Intentional poisoning of children--an overlooked category of child abuse: report of seven cases and review of the literature.

    abstract::Seven instances of child abuse due to poisoning are reported; two of the children died. Forty-one cases of this form of poisoning are found in the literature. Of the total of 48 children, eight (17%) died as a result of the incident; and one was mentally retarded. The seven different agents described here are alcohol,...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: Dine MS,McGovern ME

    更新日期:1982-07-01 00:00:00

  • Recommendations for Prevention and Control of Influenza in Children, 2016-2017.

    abstract::The purpose of this statement is to update recommendations for the routine use of seasonal influenza vaccine and antiviral medications for the prevention and treatment of influenza in children. The AAP recommends annual seasonal influenza immunization for everyone 6 months and older, including children and adolescents...

    journal_title:Pediatrics

    pub_type: 杂志文章,实务指引

    doi:10.1542/peds.2016-2527

    authors: COMMITTEE ON INFECTIOUS DISEASES.

    更新日期:2016-10-01 00:00:00

  • Ketonic diet in the management of pyruvate dehydrogenase deficiency.

    abstract::Two brothers, aged 11 years 6 months and 2 years 3 months, with psychomotor and growth retardation, episodes of weakness, ataxia, ophthalmoplegia, and elevated levels of blood pyruvate were shown to have a deficiency in the pyruvate dehydrogenase complex (PDH). When they ate a diet high enough in fats to cause ketonem...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: Falk RE,Cederbaum SD,Blass JP,Gibson GE,Kark RA,Carrel RE

    更新日期:1976-11-01 00:00:00

  • The epidemiology of Staphylococcus aureus in a newborn nursery from 1970 through 1976.

    abstract::Results of seven years of epidemiologic surveillance for Staphylococcus aureus in a newborn nursery are presented as a follow-up of a study from this same institution published in 1969. Surveillance of the previous study included years 1961 through 1968. A continued rise in S. aureus colonization rates among newborns ...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: Hargiss C,Larson E

    更新日期:1978-03-01 00:00:00

  • Involving Youth With a Chronic Illness in Decision-making: Highlighting the Role of Providers.

    abstract::Decision-making is important in the context of pediatric chronic illness because children and families need to make decisions about burdensome and complex treatments on a regular basis, and children must eventually learn how to make such decisions independently. Research related to children's decision-making in medica...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2018-0516D

    authors: Miller VA

    更新日期:2018-11-01 00:00:00

  • Body Composition in Adolescents During Treatment With Selective Serotonin Reuptake Inhibitors.

    abstract:OBJECTIVES:To examine the independent contribution of major depressive disorder (MDD), generalized anxiety disorder (GAD), and selective serotonin reuptake inhibitors (SSRIs) to changes in body composition in older adolescents. METHODS:Medically healthy 15- to 20-year-olds who were unmedicated or within 1 month of sta...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2016-3943

    authors: Calarge CA,Mills JA,Janz KF,Burns TL,Coryell WH,Zemel BS

    更新日期:2017-07-01 00:00:00

  • Girls with fragile X syndrome: physical and neurocognitive status and outcome.

    abstract::The fragile X syndrome, a common X-linked form of mental retardation and autism, affects females as well as males. Previous work has shown that approximately 35% of heterozygotes (women who carry the fragile X gene) demonstrate cognitive impairment. Thirty-two girls, 18 years or younger, who demonstrate the fragile X ...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: Hagerman RJ,Jackson C,Amiri K,Silverman AC,O'Connor R,Sobesky W

    更新日期:1992-03-01 00:00:00

  • Bone scintigraphy in the evaluation of children with obscure skeletal pain.

    abstract::A retrospective analysis of bone scans of 381 children with unexplained skeletal pain was made. Of these, findings are reported on 358 for whom there were sufficient clinical data. The bone scan results suggested trauma as the cause of pain in 43 patients, inflammatory disease in 73 patients, and neoplasia in ten pati...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:

    authors: ter Meulen DC,Majd M

    更新日期:1987-04-01 00:00:00

  • Evaluation of community-based health projects: the healthy tomorrows experience.

    abstract:OBJECTIVES:To address the "millennial morbidities," pediatricians must partner with community-based organizations to develop interventions. Little is known about the capacity of the resulting programs for program evaluation or the importance of evaluation in project success and sustainability. The objective of this stu...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2006-3273

    authors: Ruch-Ross H,Keller D,Miller N,Bassewitz J,Melinkovich P

    更新日期:2008-09-01 00:00:00

  • Cognitive function and behavior of children with adenotonsillar hypertrophy suspected of having obstructive sleep-disordered breathing.

    abstract:OBJECTIVE:The purpose of this study was to determine whether risks of impaired cognitive function could be predicted for children or groups of children with adenotonsillar hypertrophy who were suspected of having obstructive sleep-disordered breathing, from historical and polysomnographic variables used separately or i...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2006-0173

    authors: Suratt PM,Peruggia M,D'Andrea L,Diamond R,Barth JT,Nikova M,Perriello VA Jr,Johnson ML

    更新日期:2006-09-01 00:00:00

  • Cigarette Tax Increase and Infant Mortality.

    abstract:BACKGROUND AND OBJECTIVE:Maternal smoking increases the risk for preterm birth, low birth weight, and sudden infant death syndrome, which are all causes of infant mortality. Our objective was to evaluate if changes in cigarette taxes and prices over time in the United States were associated with a decrease in infant mo...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2015-2901

    authors: Patrick SW,Warner KE,Pordes E,Davis MM

    更新日期:2016-01-01 00:00:00

  • Improving the quality of discharge communication with an educational intervention.

    abstract:BACKGROUND:Communication between hospital providers and primary care physicians at the time of hospital discharge is necessary for optimal patient care and safety. Content of the inpatient discharge summary (DS) is not uniformly addressed by residency programs. OBJECTIVE:To improve DSs quality through a brief educatio...

    journal_title:Pediatrics

    pub_type: 杂志文章

    doi:10.1542/peds.2010-0884

    authors: Key-Solle M,Paulk E,Bradford K,Skinner AC,Lewis MC,Shomaker K

    更新日期:2010-10-01 00:00:00

  • Research ethics in the MySpace era.

    abstract::Social networking web sites are popular among adolescents and may represent a new venue for conducting adolescent health research. Conducting research by using social networking web sites raises several concerns, including the social value of this research, fair subject selection, confidentiality, privacy, and informe...

    journal_title:Pediatrics

    pub_type: 杂志文章,评审

    doi:10.1542/peds.2007-3015

    authors: Moreno MA,Fost NC,Christakis DA

    更新日期:2008-01-01 00:00:00