Advertisement
Advances in Pediatrics

Advances in Pediatric Pharmacology, Therapeutics, and Toxicology

      In September 2005, the American Academy of Pediatrics (AAP) celebrated its 75th anniversary. As part of the celebration of this milestone, the AAP recognized the 10 greatest advancements in child health over that time, to which the group contributed [

      American Academy of Pediatrics. Available at: http://www.aap.org/advocacy/releases/feb0575.htm. Accessed December 4, 2006.

      ]. One of these was the advocacy that led to the 1998 Final Rule, which required that new drugs be studied in children if they provided a significant therapeutic benefit over existing therapies, if the absence of pediatric labeling posed a risk to children, or if the new therapy provided a treatment where no others existed [
      Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients—FDA. Final rule.
      ]. This advocacy also led to the Pediatric Research Equity Act (PREA) of 2003 and The Best Pharmaceuticals for Children Act (BPCA) that was passed by the US Congress in 2002 [
      • Starke P.R.
      • Weaver J.
      • Chowdhury B.A.
      Boxed warning added to promethazine labeling for pediatric use.
      ], a law that provides incentives for industry to conduct trials with children for drugs already approved for adults or those in development.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Advances in Pediatrics
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

      1. American Academy of Pediatrics. Available at: http://www.aap.org/advocacy/releases/feb0575.htm. Accessed December 4, 2006.

      2. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients—FDA. Final rule.
        Fed Regist. 1998; 63: 66631-66672
        • Starke P.R.
        • Weaver J.
        • Chowdhury B.A.
        Boxed warning added to promethazine labeling for pediatric use.
        N Engl J Med. 2005; 352: 2653
        • Wilson J.T.
        An update on the therapeutic orphan.
        Pediatrics. 1999; 104: 585-590
      3. US Food and Drug Administration. Approved active moieties to which FDA has granted pediatric exclusivity for pediatric studies under Section 505A of the Federal Food, Drug, and Cosmetic Act. Available at: http://www.fda.gov/cder/pediatric/exgrant.htm. Accessed December 4, 2006.

        • DeAngelis C.D.
        • Drazen J.M.
        • Frizelle F.A.
        • et al.
        Clinical trial registration: a statement from the International Committee of Medical Journal Editors.
        JAMA. 2004; 292: 1363-1364
        • Allotey P.
        • Reidpath D.D.
        • Elisha D.
        Social medication and the control of children: a qualitative study of over-the-counter medication among Australian children.
        Pediatrics. 2004; 114: e378-e383
        • Sarrell E.M.
        • Wielunsky E.
        • Cohen H.A.
        Antipyretic treatment in young children with fever: acetaminophen, ibuprofen, or both alternating in a randomized, double-blind study.
        Arch Pediatr Adolesc Med. 2006; 160: 197-202
        • Erlewyn-Lajeunesse M.D.
        • Coppens K.
        • Hunt L.P.
        • et al.
        Randomised controlled trial of combined paracetamol and ibuprofen for fever.
        Arch Dis Child. 2006; 91: 414-416
      4. Acetaminophen toxicity in children.
        Pediatrics. 2001; 108: 1020-1024
        • Walson P.D.
        • Jones J.
        • Chesney R.
        • et al.
        Antipyretic efficacy and tolerability of a single intravenous dose of the acetaminophen prodrug propacetamol in children: a randomized, double-blind, placebo-controlled trial.
        Clin Ther. 2006; 28: 762-769
      5. Use of codeine- and dextromethorphan-containing cough remedies in children. American Academy of Pediatrics. Committee on Drugs.
        Pediatrics. 1997; 99: 918-920
        • Paul I.M.
        • Yoder K.E.
        • Crowell K.R.
        • et al.
        Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents.
        Pediatrics. 2004; 114: e85-e90
        • Chang A.B.
        • Glomb W.B.
        Guidelines for evaluating chronic cough in pediatrics: ACCP evidence-based clinical practice guidelines.
        Chest. 2006; 129: 260S-283S
      6. US Food and Drug Administration. Available at: http://www.fda.gov/ohrms/dockets/98fr/E6–8982.pdf. Accessed December 5, 2006.

      7. US Food and Drug Administration. Novartis Consumer Health conducts nationwide voluntary recall of Triaminic Vapor Patch product in U.S. Available at: http://www.fda.gov/oc/po/firmrecalls/Novartis6_06.html. Accessed December 5, 2006.

        • Bjornson C.L.
        • Klassen T.P.
        • Williamson J.
        • et al.
        A randomized trial of a single dose of oral dexamethasone for mild croup.
        N Engl J Med. 2004; 351: 1306-1313
        • Scolnik D.
        • Coates A.L.
        • Stephens D.
        • et al.
        Controlled delivery of high vs low humidity vs mist therapy for croup in emergency departments: a randomized controlled trial.
        JAMA. 2006; 295: 1274-1280
        • Olympia R.P.
        • Khine H.
        • Avner J.R.
        Effectiveness of oral dexamethasone in the treatment of moderate- to-severe pharyngitis in children.
        Arch Pediatr Adolesc Med. 2005; 159: 278-282
        • Linder J.A.
        • Bates D.W.
        • Lee G.M.
        • et al.
        Antibiotic treatment of children with sore throat.
        JAMA. 2005; 294: 2315-2322
      8. US Food and Drug Administration. Promethazine Hydrochloride. Available at: http://www.fda.gov/cder/drug/InfoSheets/HCP/promethazineHCP.pdf. Accessed December 5, 2006.

        • Freedman S.B.
        • Adler M.
        • Seshadri R.
        • et al.
        Oral ondansetron for gastroenteritis in a pediatric emergency department.
        N Engl J Med. 2006; 354: 1698-1705
        • Casey J.R.
        • Pichichero M.E.
        Meta-analysis of short course antibiotic treatment for group a streptococcal tonsillopharyngitis.
        Pediatr Infect Dis J. 2005; 24: 909-917
        • Blumer J.L.
        • Reed M.D.
        • Kaplan E.L.
        • et al.
        Explaining the poor bacteriologic eradication rate of single-dose ceftriaxone in group a streptococcal tonsillopharyngitis: a reverse engineering solution using pharmacodynamic modeling.
        Pediatrics. 2005; 116: 927-932
        • Arguedas A.
        • Emparanza P.
        • Schwartz R.H.
        • et al.
        A randomized, multicenter, double-blind, double dummy trial of single dose azithromycin versus high-dose amoxicillin for treatment of uncomplicated acute otitis media.
        Pediatr Infect Dis J. 2005; 24: 153-161
        • Hoberman A.
        • Dagan R.
        • Leibovitz E.
        • et al.
        Large dosage amoxicillin/clavulanate compared with azithromycin for the treatment of bacterial acute otitis media in children.
        Pediatr Infect Dis J. 2005; 24: 525-532
        • Rosenfeld R.M.
        • Singer M.
        • Wasserman J.M.
        • et al.
        Systematic review of topical antimicrobial therapy for acute otitis externa.
        Otolaryngol Head Neck Surg. 2006; 134: S24-S48
        • Rosenfeld R.M.
        • Brown L.
        • Cannon C.R.
        • et al.
        Clinical practice guideline: acute otitis externa.
        Otolaryngol Head Neck Surg. 2006; 134: S4-S23
        • Addo-Yobo E.
        • Chisaka N.
        • Hassan M.
        • et al.
        Oral amoxicillin versus injectable penicillin for severe pneumonia in children aged 3 to 59 months: a randomised multicentre equivalency study.
        Lancet. 2004; 364: 1141-1148
        • Garin E.H.
        • Olavarria F.
        • Garcia Nieto V.
        • et al.
        Clinical significance of primary vesicoureteral reflux and urinary antibiotic prophylaxis after acute pyelonephritis: a multicenter, randomized, controlled study.
        Pediatrics. 2006; 117: 626-632
        • Saha D.
        • Khan W.A.
        • Karim M.M.
        • et al.
        Single-dose ciprofloxacin versus 12-dose erythromycin for childhood cholera: a randomised controlled trial.
        Lancet. 2005; 366: 1085-1093
        • Fleece D.
        • Gaughan J.P.
        • Aronoff S.C.
        Griseofulvin versus terbinafine in the treatment of tinea capitis: a meta-analysis of randomized, clinical trials.
        Pediatrics. 2004; 114: 1312-1315
        • Abdel-Rahman S.M.
        • Herron J.
        • Fallon-Friedlander S.
        • et al.
        Pharmacokinetics of terbinafine in young children treated for tinea capitis.
        Pediatr Infect Dis J. 2005; 24: 886-891
        • Gonzalez-Peralta R.P.
        • Kelly D.A.
        • Haber B.
        • et al.
        Interferon alfa-2b in combination with ribavirin for the treatment of chronic hepatitis C in children: efficacy, safety, and pharmacokinetics.
        Hepatology. 2005; 42: 1010-1018
        • Guilbert T.W.
        • Morgan W.J.
        • Zeiger R.S.
        • et al.
        Long-term inhaled corticosteroids in preschool children at high risk for asthma.
        N Engl J Med. 2006; 354: 1985-1997
        • Bisgaard H.
        • Hermansen M.N.
        • Loland L.
        • et al.
        Intermittent inhaled corticosteroids in infants with episodic wheezing.
        N Engl J Med. 2006; 354: 1998-2005
        • Szefler S.J.
        • Phillips B.R.
        • Martinez F.D.
        • et al.
        Characterization of within-subject responses to fluticasone and montelukast in childhood asthma.
        J Allergy Clin Immunol. 2005; 115: 233-242
        • Zeiger R.S.
        • Szefler S.J.
        • Phillips B.R.
        • et al.
        Response profiles to fluticasone and montelukast in mild-to-moderate persistent childhood asthma.
        J Allergy Clin Immunol. 2006; 117: 45-52
        • Ostrom N.K.
        • Decotiis B.A.
        • Lincourt W.R.
        • et al.
        Comparative efficacy and safety of low-dose fluticasone propionate and montelukast in children with persistent asthma.
        J Pediatr. 2005; 147: 213-220
        • Garcia Garcia M.L.
        • Wahn U.
        • Gilles L.
        • et al.
        Montelukast, compared with fluticasone, for control of asthma among 6- to 14-year-old patients with mild asthma: the MOSAIC study.
        Pediatrics. 2005; 116: 360-369
      9. US Food and Drug Administration. FDA public health advisory. Available at: http://www.fda.gov/cder/drug/advisory/LABA.htm. Accessed December 11, 2006.

        • McIntyre J.
        • Robertson S.
        • Norris E.
        • et al.
        Safety and efficacy of buccal midazolam versus rectal diazepam for emergency treatment of seizures in children: a randomised controlled trial.
        Lancet. 2005; 366: 205-210
        • Ahmad S.
        • Ellis J.C.
        • Kamwendo H.
        • et al.
        Efficacy and safety of intranasal lorazepam versus intramuscular paraldehyde for protracted convulsions in children: an open randomised trial.
        Lancet. 2006; 367: 1591-1597
        • Lewis D.
        • Ashwal S.
        • Hershey A.
        • et al.
        Practice parameter: pharmacological treatment of migraine headache in children and adolescents: report of the American Academy of Neurology Quality Standards Subcommittee and the Practice Committee of the Child Neurology Society.
        Neurology. 2004; 63: 2215-2224
      10. US Food and Drug Administration. FDA takes action on Plan B statement. Available at: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01251.html. Accessed December 14, 2006.

        • Kurtzberg J.
        • Ernst T.J.
        • Keating M.J.
        • et al.
        Phase I study of 506U78 administered on a consecutive 5-day schedule in children and adults with refractory hematologic malignancies.
        J Clin Oncol. 2005; 23: 3396-3403
        • Lipshultz S.E.
        • Rifai N.
        • Dalton V.M.
        • et al.
        The effect of dexrazoxane on myocardial injury in doxorubicin-treated children with acute lymphoblastic leukemia.
        N Engl J Med. 2004; 351: 145-153
        • Flynn J.T.
        • Newburger J.W.
        • Daniels S.R.
        • et al.
        A randomized, placebo-controlled trial of amlodipine in children with hypertension.
        J Pediatr. 2004; 145: 353-359
        • Egami K.
        • Muta H.
        • Ishii M.
        • et al.
        Prediction of resistance to intravenous immunoglobulin treatment in patients with Kawasaki disease.
        J Pediatr. 2006; 149: 237-240
        • Tsai M.H.
        • Huang Y.C.
        • Yen M.H.
        • et al.
        Clinical responses of patients with Kawasaki disease to different brands of intravenous immunoglobulin.
        J Pediatr. 2006; 148: 38-43
        • Burns J.C.
        • Mason W.H.
        • Hauger S.B.
        • et al.
        Infliximab treatment for refractory Kawasaki syndrome.
        J Pediatr. 2005; 146: 662-667
        • Wooditch A.C.
        • Aronoff S.C.
        Effect of initial corticosteroid therapy on coronary artery aneurysm formation in Kawasaki disease: a meta-analysis of 862 children.
        Pediatrics. 2005; 116: 989-995
      11. US Food and Drug Administration. FDA public health advisory. Available at: http://www.fda.gov/cder/drug/advisory/elidel_protopic.htm. Accessed December 14, 2006.

      12. US Food and Drug Administration. Isotretinoin (marketed as Accutane) capsule information. Available at: http://www.fda.gov/cder/drug/infopage/accutane/default.htm. Accessed December 15, 2006.

        • Speiser P.W.
        • Rudolf M.C.
        • Anhalt H.
        • et al.
        Childhood obesity.
        J Clin Endocrinol Metab. 2005; 90: 1871-1887
        • Godoy-Matos A.
        • Carraro L.
        • Vieira A.
        • et al.
        Treatment of obese adolescents with sibutramine: a randomized, double-blind, controlled study.
        J Clin Endocrinol Metab. 2005; 90: 1460-1465
        • Garcia-Morales L.M.
        • Berber A.
        • Macias-Lara C.C.
        • et al.
        Use of sibutramine in obese Mexican adolescents: a 6-month, randomized, double-blind, placebo-controlled, parallel-group trial.
        Clin Ther. 2006; 28: 770-782
        • Chanoine J.P.
        • Hampl S.
        • Jensen C.
        • et al.
        Effect of orlistat on weight and body composition in obese adolescents: a randomized controlled trial.
        JAMA. 2005; 293: 2873-2883
        • Ibanez L.
        • de Zegher F.
        Low-dose combination of flutamide, metformin, and an oral contraceptive for nonobese, young women with polycystic ovary syndrome.
        Hum Reprod. 2003; 18: 57-60
        • Mechcatie E.
        FDA OKs single-rod implantable contraceptive.
        Pediatr News. 2006; 8: 42-43
      13. US Food and Drug Administration. Statement on Adderall. Available at: http://www.fda.gov/bbs/topics/news/2005/NEW01262.html. Accessed December 15, 2006.

        • Bonny A.E.
        • Ziegler J.
        • Harvey R.
        • et al.
        Weight gain in obese and nonobese adolescent girls initiating depot medroxyprogesterone, oral contraceptive pills, or no hormonal contraceptive method.
        Arch Pediatr Adolesc Med. 2006; 160: 40-45
        • Scholes D.
        • LaCroix A.Z.
        • Ichikawa L.E.
        • et al.
        Change in bone mineral density among adolescent women using and discontinuing depot medroxyprogesterone acetate contraception.
        Arch Pediatr Adolesc Med. 2005; 159: 139-144
        • Harper C.C.
        • Rocca C.H.
        • Darney P.D.
        • et al.
        Tolerability of levonorgestrel emergency contraception in adolescents.
        Am J Obstet Gynecol. 2004; 191: 1158-1163
      14. Emergency contraception.
        Pediatrics. 2005; 116: 1026-1035
        • Raine T.R.
        • Harper C.C.
        • Rocca C.H.
        • et al.
        Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial.
        JAMA. 2005; 293: 54-62
        • Harper C.C.
        • Cheong M.
        • Rocca C.H.
        • et al.
        The effect of increased access to emergency contraception among young adolescents.
        Obstet Gynecol. 2005; 106: 483-491
        • Brown R.T.
        • Amler R.W.
        • Freeman W.S.
        • et al.
        Treatment of attention-deficit/hyperactivity disorder: overview of the evidence.
        Pediatrics. 2005; 115: e749-e757
        • Wolraich M.L.
        • Wibbelsman C.J.
        • Brown T.E.
        • et al.
        Attention-deficit/hyperactivity disorder among adolescents: a review of the diagnosis, treatment, and clinical implications.
        Pediatrics. 2005; 115: 1734-1746
      15. Health Canada. Health Canada suspends the market authorization of ADDERALL XR, a drug prescribed for attention deficit hyperactivity disorder (ADHD) in children. Available at: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2005/2005_01_e.html. Accessed December 19, 2006.

      16. US Food and Drug Administration. Public health advisory for Adderall and Adderall XR. Available at: http://www.fda.gov/cder/drug/advisory/adderall.htm. Accessed December 19, 2006.

        • Findling R.L.
        • Biederman J.
        • Wilens T.E.
        • et al.
        Short- and long-term cardiovascular effects of mixed amphetamine salts extended release in children.
        J Pediatr. 2005; 147: 348-354
      17. US Food and Drug Administration. FDA issues public health advisory on Strattera (Atomoxetine) for attention deficit disorder. Available at: http://www.fda.gov/bbs/topics/news/2005/new01237.html. Accessed December 19, 2006.

        • March J.
        • Silva S.
        • Petrycki S.
        • et al.
        Fluoxetine, cognitive–behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial.
        JAMA. 2004; 292: 807-820
      18. US Food and Drug Administration. Labeling change request letter for antidepressant medications. Available at: http://www.fda.gov/cder/drug/antidepressants/SSRIlabelChange.htm. Accessed December 21, 2006.

        • Leslie L.K.
        • Newman T.B.
        • Chesney P.J.
        • et al.
        The Food and Drug Administration's deliberations on antidepressant use in pediatric patients.
        Pediatrics. 2005; 116: 195-204
        • Simon G.E.
        • Savarino J.
        • Operskalski B.
        • et al.
        Suicide risk during antidepressant treatment.
        Am J Psychiatry. 2006; 163: 41-47
        • Hammad T.A.
        • Laughren T.
        • Racoosin J.
        Suicidality in pediatric patients treated with antidepressant drugs.
        Arch Gen Psychiatry. 2006; 63: 332-339
        • Rappaport N.
        • Bostic J.Q.
        • Prince J.B.
        • et al.
        Treating pediatric depression in primary care: coping with the patient's blue mood and the FDA's black box.
        J Pediatr. 2006; 148: 567-568
        • Shea S.
        • Turgay A.
        • Carroll A.
        • et al.
        Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders.
        Pediatrics. 2004; 114: e634-e641
        • Troost P.W.
        • Lahuis B.E.
        • Steenhuis M.P.
        • et al.
        Long-term effects of risperidone in children with autism spectrum disorders: a placebo discontinuation study.
        J Am Acad Child Adolesc Psychiatry. 2005; 44: 1137-1144
        • Giacoia G.P.
        • Mattison D.R.
        Newborns and drug studies: the NICHD/FDA newborn drug development initiative.
        Clin Ther. 2005; 27: 796-813
        • Giacoia G.P.
        • Birenbaum D.L.
        • Sachs H.C.
        • et al.
        The newborn drug development initiative.
        Pediatrics. 2006; 117: S1-S8
        • Clark R.H.
        • Bloom B.T.
        • Spitzer A.R.
        • et al.
        Reported medication use in the neonatal intensive care unit: data from a large national data set.
        Pediatrics. 2006; 117: 1979-1987
        • Schmidt B.
        • Roberts R.S.
        • Davis P.
        • et al.
        Caffeine therapy for apnea of prematurity.
        N Engl J Med. 2006; 354: 2112-2121
        • Watterberg K.L.
        • Gerdes J.S.
        • Cole C.H.
        • et al.
        Prophylaxis of early adrenal insufficiency to prevent bronchopulmonary dysplasia: a multicenter trial.
        Pediatrics. 2004; 114: 1649-1657
        • Ng P.C.
        • Lee C.H.
        • Bnur F.L.
        • et al.
        A double-blind, randomized, controlled study of a stress dose of hydrocortisone for rescue treatment of refractory hypotension in preterm infants.
        Pediatrics. 2006; 117: 367-375
        • Finer N.N.
        • Powers R.J.
        • Ou C.H.
        • et al.
        Prospective evaluation of postnatal steroid administration: a 1-year experience from the California Perinatal Quality Care Collaborative.
        Pediatrics. 2006; 117: 704-713
        • Colombo D.F.
        • Lew J.L.
        • Pedersen C.A.
        • et al.
        Optimal timing of ampicillin administration to pregnant women for establishing bactericidal levels in the prophylaxis of group B Streptococcus.
        Am J Obstet Gynecol. 2006; 194: 466-470
        • Clark R.H.
        • Bloom B.T.
        • Spitzer A.R.
        • et al.
        Empiric use of ampicillin and cefotaxime, compared with ampicillin and gentamicin, for neonates at risk for sepsis is associated with an increased risk of neonatal death.
        Pediatrics. 2006; 117: 67-74
        • Bertini G.
        • Perugi S.
        • Dani C.
        • et al.
        Fluconazole prophylaxis prevents invasive fungal infection in high-risk, very low birth weight infants.
        J Pediatr. 2005; 147: 162-165
        • Anand K.J.
        • Aranda J.V.
        • Berde C.B.
        • et al.
        Summary proceedings from the neonatal pain-control group.
        Pediatrics. 2006; 117: S9-S22
        • Aranda J.V.
        • Carlo W.
        • Hummel P.
        • et al.
        Analgesia and sedation during mechanical ventilation in neonates.
        Clin Ther. 2005; 27: 877-899
        • Bhandari V.
        • Bergqvist L.L.
        • Kronsberg S.S.
        • et al.
        Morphine administration and short-term pulmonary outcomes among ventilated preterm infants.
        Pediatrics. 2005; 116: 352-359
        • Anand K.J.
        • Johnston C.C.
        • Oberlander T.F.
        • et al.
        Analgesia and local anesthesia during invasive procedures in the neonate.
        Clin Ther. 2005; 27: 844-876
        • Carbajal R.
        • Lenclen R.
        • Jugie M.
        • et al.
        Morphine does not provide adequate analgesia for acute procedural pain among preterm neonates.
        Pediatrics. 2005; 115: 1494-1500
        • Taddio A.
        • Lee C.
        • Yip A.
        • et al.
        Intravenous morphine and topical tetracaine for treatment of pain in [corrected] neonates undergoing central line placement.
        JAMA. 2006; 295: 793-800
        • Guillet R.
        • Stoll B.J.
        • Cotten C.M.
        • et al.
        Association of H2-blocker therapy and higher incidence of necrotizing enterocolitis in very low birth weight infants.
        Pediatrics. 2006; 117: e137-e142
        • Sanz E.J.
        • De-las-Cuevas C.
        • Kiuru A.
        • et al.
        Selective serotonin reuptake inhibitors in pregnant women and neonatal withdrawal syndrome: a database analysis.
        Lancet. 2005; 365: 482-487
        • Levinson-Castiel R.
        • Merlob P.
        • Linder N.
        • et al.
        Neonatal abstinence syndrome after in utero exposure to selective serotonin reuptake inhibitors in term infants.
        Arch Pediatr Adolesc Med. 2006; 160: 173-176
        • Moses-Kolko E.L.
        • Bogen D.
        • Perel J.
        • et al.
        Neonatal signs after late in utero exposure to serotonin reuptake inhibitors: literature review and implications for clinical applications.
        JAMA. 2005; 293: 2372-2383
        • Oberlander T.F.
        • Grunau R.E.
        • Fitzgerald C.
        • et al.
        Pain reactivity in 2-month-old infants after prenatal and postnatal serotonin reuptake inhibitor medication exposure.
        Pediatrics. 2005; 115: 411-425
        • Chambers C.D.
        • Hernandez-Diaz S.
        • Van Marter L.J.
        • et al.
        Selective serotonin-reuptake inhibitors and risk of persistent pulmonary hypertension of the newborn.
        N Engl J Med. 2006; 354: 579-587
        • Cooper W.O.
        • Hernandez-Diaz S.
        • Arbogast P.G.
        • et al.
        Major congenital malformations after first-trimester exposure to ACE inhibitors.
        N Engl J Med. 2006; 354: 2443-2451
        • Carmichael S.L.
        • Shaw G.M.
        • Laurent C.
        • et al.
        Maternal progestin intake and risk of hypospadias.
        Arch Pediatr Adolesc Med. 2005; 159: 957-962
        • Nitsun M.
        • Szokol J.W.
        • Saleh H.J.
        • et al.
        Pharmacokinetics of midazolam, propofol, and fentanyl transfer to human breast milk.
        Clin Pharmacol Ther. 2006; 79: 549-557
        • Hong L.
        • Levy S.M.
        • Warren J.J.
        • et al.
        Association of amoxicillin use during early childhood with developmental tooth enamel defects.
        Arch Pediatr Adolesc Med. 2005; 159: 943-948
        • Dart R.C.
        • Erdman A.R.
        • Olson K.R.
        • et al.
        Acetaminophen poisoning: an evidence-based consensus guideline for out-of-hospital management.
        Clin Toxicol (Phila). 2006; 44: 1-18
        • Sinha Y.
        • Cranswick N.E.
        Clonidine poisoning in children: a recent experience.
        J Paediatr Child Health. 2004; 40: 678-680
        • Spiller H.A.
        • Klein-Schwartz W.
        • Colvin J.M.
        • et al.
        Toxic clonidine ingestion in children.
        J Pediatr. 2005; 146: 263-266