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recently approved medications for children and adolescents

Ritu Goel, Ji Su Hong, Robert L Findling, Na Young Ji
To date, no medication is proven to be effective in treating core symptoms of autism spectrum disorder (ASD). Psychotropic medications are widely used to target emotional and behavioural symptoms in ASD. This article reviewed evidence for pharmacotherapy, novel therapeutic agents, and Complementary and Alternative Medicine (CAM) in children and adolescents with ASD. Currently, only risperidone and aripiprazole have been approved by the US Food and Drug Administration (FDA) for treatment of irritability associated with ASD in children and adolescents...
April 25, 2018: International Review of Psychiatry
Geoffrey Rulong, Thomas Dye, Narong Simakajornboon
Restless legs syndrome (RLS) and periodic limb movement disorder (PLMD) are under-recognized sleep disorders in children and adolescents. Several recent epidemiological studies have shown that RLS and PLMD are common in the pediatric population, and if left untreated, may lead to cardiovascular and neurocognitive consequences. Therefore, early diagnosis and intervention may help preventing long-term consequences. The management of RLS and PLMD in children involves both non-pharmacologic and pharmacologic approaches...
February 2018: Paediatric Drugs
Hengameh H Raissy, H William Kelly
Evidence is emerging on the use of long-acting muscarinic antagonists (LAMAs) in the management of asthma. Tiotropium bromide (Spiriva® Respimat® ) is the only LAMA approved in children and adolescents. As the use of tiotropium becomes more common in clinical practice, it is necessary to review the existing data to identify patients who may benefit from the addition of this medication to their daily asthma regimen. This review discusses recent evidence on the safety and efficacy of tiotropium bromide in the management of asthma in children and adolescents...
December 2017: Paediatric Drugs
Małgorzata Steczkowska, Barbara Skowronek-Bała, Teresa Bawół
Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system. The disease usually affects young people, although it may also occur in early childhood. As well as the availability of diagnostic methods rises also the possibility of disease-modifying treatment increases. With constant development of diagnostic methods also the possibility of disease-modifying treatment (DMT) increases. Since 2012 in Poland a therapeutic program of the National Health Fund gives the possibility of using first-line therapy treatment in children/adolescents with multiple sclerosis (over 12 years of age), and since June 2015 using the interferon beta in children of 7 years old and body mass below 30 kg has been approved...
2016: Przegla̧d Lekarski
A S Kelly, C K Fox, K D Rudser, A C Gross, J R Ryder
Despite the increasing number of medications recently approved to treat obesity among adults, few agents have been formally evaluated in children or adolescents for this indication. Moreover, there is a paucity of guidance in the literature addressing best practices with regard to pediatric obesity pharmacotherapy clinical trial design, and only general recommendations have been offered by regulatory agencies on this topic. The purposes of this article are to (1) offer a background of the current state of the field of pediatric obesity medicine, (2) provide a brief review of the literature summarizing pediatric obesity pharmacotherapy clinical trials, and (3) highlight and discuss some of the unique aspects that should be considered when designing and conducting high-quality clinical trials evaluating the safety and efficacy of obesity medications in children and adolescents...
July 2016: International Journal of Obesity: Journal of the International Association for the Study of Obesity
A Häge, T Banaschewski, R W Dittmann
Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder - which may persist into adolescence and adulthood. Psychostimulants and atomoxetine (ATX) are frequently prescribed to treat ADHD in Germany. Lisdexamfetamine dimesylate (LDX) is the most recently approved ADHD medication in Germany and other European countries. Data used to support the European registration of LDX is summarised from three phase-3/3b studies in children and adolescents with ADHD. Short-term efficacy (study SPD489 - 325), maintenance of efficacy (study SPD489 - 326) and efficacy in patients who had previously responded inadequately to methylphenidate (MPH) treatment (study SPD489 - 317) were demonstrated...
December 2015: Fortschritte der Neurologie-Psychiatrie
Aaron S Kelly
Obesity is a complex and retractable disease for which effective and durable treatments are elusive. Successful treatment of severe obesity with lifestyle modification therapy alone is highly unlikely, particularly for adolescents. Pharmacotherapy, if appropriately prescribed, can be an effective tool to use in conjunction with lifestyle modification therapy to achieve better weight loss outcomes. Only a few obesity medications have been evaluated in children and adolescents with results suggesting modest efficacy...
2016: Endocrine Development
Michael Huss, Wai Chen, Andrea G Ludolph
Children/adolescents with attention-deficit/hyperactivity disorder (ADHD) may have a poor or inadequate response to psychostimulants or be unable to tolerate their side-effects; furthermore, stimulants may be inappropriate because of co-existing conditions. Only one non-stimulant ADHD pharmacotherapy, the noradrenaline transporter inhibitor atomoxetine, is currently approved for use in Europe. We review recent advances in understanding of the pathophysiology of ADHD with a focus on the roles of catecholamine receptors in context of the α2A-adrenergic receptor agonist guanfacine extended release (GXR), a new non-stimulant treatment option in Europe...
January 2016: Clinical Drug Investigation
Melissa L Miller, Chanin C Wright, Barry Browne
As demonstrated by the 2011 publication of the National Heart, Lung, and Blood Institute Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents, the information available regarding the treatment of pediatric lipid disorders has greatly expanded. HMG-CoA reductase inhibitor, or statin, therapy is now considered a first-line pharmacologic intervention for pediatric patients with severe dyslipidemias failing treatment with diet and exercise alone. Despite their ability to effectively reduce cholesterol levels, bile acid sequestrants continue to pose challenges for pediatric patients because of their unpalatability and are typically used as adjunctive therapy or for patients not able to tolerate statins...
September 2015: Journal of Clinical Lipidology
William E Berger, Eli O Meltzer
BACKGROUND: Intranasal sprays are recommended as targeted therapy for allergic rhinitis (AR) by providing direct delivery of medication to the nasal mucosa, reducing the potential for systemic adverse effects, decreasing burden of disease, and improving quality of life. OBJECTIVE: To review currently available intranasal sprays indicated for maintenance therapy of AR in the United States: intranasal antihistamines (INAH); intranasal corticosteroids (INCS); and MP-AzeFlu, a single formulation nasal spray of the INAH, azelastine hydrochloride, and the INCS, fluticasone propionate...
July 2015: American Journal of Rhinology & Allergy
W E Berger, E O Meltzer
BACKGROUND: Intranasal sprays are recommended as targeted therapy for allergic rhinitis (AR) by providing direct delivery of medication to the nasal mucosa, reducing the potential for systemic adverse effects, decreasing burden of disease, and improving quality of life. OBJECTIVE: To review currently available intranasal sprays indicated for maintenance therapy of AR in the United States: intranasal antihistamines (INAH); intranasal corticosteroids (INCS); and MP-AzeFlu, a single formulation nasal spray of the INAH, azelastine hydrochloride, and the INCS, fluticasone propionate...
June 22, 2015: American Journal of Rhinology & Allergy
Jose Martinez-Raga, Carlos Knecht, Raquel de Alvaro
The α2-adrenergic receptor agonist guanfacine, in its extended-release formulation (GXR), is the most recent nonstimulant medication approved in several countries for the treatment of attention-deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive pharmacotherapy to stimulants in children and adolescents. The present paper aims to review comprehensively and critically the pharmacodynamic and pharmacokinetic characteristics and the published evidence on the efficacy and safety profile of GXR in the treatment of ADHD...
2015: Neuropsychiatric Disease and Treatment
Christine Schmäl, Katja Becker, Ruth Berg, Michael Brünger, Gerd Lehmkuhl, Klaus-Ulrich Oehler, Thorsten Ruppert, Claus Staudter, Götz-Erik Trott, Ralf W Dittmann
Although the use of psychotropic medications in child and adolescent psychiatry in Germany is on the increase, most compounds are in fact prescribed "off-label" because of a lack of regulatory approval in these age groups. In 2007, the European Parliament introduced Regulation 1901/2006 concerning medicinal products in pediatric populations, with a subsequent amendment in the form of Regulation 1902/2006. The main aim of this legislation was to encourage research and clinical trials in children and adolescents, and thus promote the availability of medications with marketing authorization for these age groups...
November 2014: Zeitschrift Für Kinder- und Jugendpsychiatrie und Psychotherapie
Frederick G Freitag, Derrick Shumate
There are only a handful of drugs that have been submitted for and received an indication for the preventative treatment of migraine by the US Food and Drug Administration, as well as international governmental regulatory agencies. However, there are a wide variety of agents that are used for this indication with different levels of evidence for efficacy and tolerability. Several guidelines have been published in recent years examining the evidence-based medicine of migraine preventative therapy and these provide guidance especially for the primary care clinician, but also for neurologists whose primary focus is not headache medicine...
October 2014: CNS Drugs
Martin A Katzman, Tia Sternat
Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioural disorder with onset during childhood. It affects a child's development, both at home and at school, and impacts on social, emotional and cognitive functioning, in both the home and the school environment. Untreated ADHD is very often associated with poor academic achievement, low occupational status, increased risk of substance abuse and delinquency. Current practice guidelines recommend a multimodal approach in the treatment of ADHD, which includes educational, behavioural and mental health interventions, and pharmacological management...
November 2014: CNS Drugs
J Peuskens, L Pani, J Detraux, M De Hert
Since the 1970s, clinicians have increasingly become more familiar with hyperprolactinemia (HPRL) as a common adverse effect of antipsychotic medication, which remains the cornerstone of pharmacological treatment for patients with schizophrenia. Although treatment with second-generation antipsychotics (SGAs) as a group is, compared with use of the first-generation antipsychotics, associated with lower prolactin (PRL) plasma levels, the detailed effects on plasma PRL levels for each of these compounds in reports often remain incomplete or inaccurate...
May 2014: CNS Drugs
N S Roskell, J Setyawan, E A Zimovetz, P Hodgkins
OBJECTIVE: Systematically review and synthesize the clinical evidence of treatments for attention deficit hyperactivity disorder (ADHD) by indirectly comparing established treatments in the UK with a drug recently approved in Europe (lisdexamfetamine [LDX]). RESEARCH DESIGN AND METHODS: HASH(0x4604a78) POPULATION: children and adolescents. SETTING: Europe. Comparators: methylphenidate (MPH), atomoxetine (ATX), and dexamphetamine (DEX)...
August 2014: Current Medical Research and Opinion
Xue Ming, Martha Mulvey, Sharanya Mohanty, Viraj Patel
Clonidine has been used off-label in children and adolescents with attention deficit and hyperactivity disorders (ADHD) with or without comorbidities. Clonidine extended-release was recently approved by the US Food and Drug Administration for ADHD in children. This review evaluates the efficacy and safety of clonidine extended-release and clonidine in children and adolescents with ADHD. A search of the Medline database and clinical trials register from 1996-2011 yielded ten clinical trials for critical evaluation of efficacy and safety...
2011: Adolescent Health, Medicine and Therapeutics
Zsófia Mészner
The real disease burden due to Streptococcus pneumoniae infections are underrecognised worldwide both by the lay public and by the medical community in general. In infants and children pneumococcal otitis media is the most common reason for antimicrobial treatment, while the far less frequent, though potentially life threatening pneumococcal pleuropneumonia, sepsis and pneumococcal meningitis are high risk conditions even if the causative pneumococcus is not multiresistant. Asplenic patients, patients with chronic underlying conditions, and/or those receiving immunosuppressive therapy are at risk of serious pneumococcal disease regardless of age...
February 16, 2014: Orvosi Hetilap
Vanja Sikirica, Robert L Findling, James Signorovitch, M Haim Erder, Ryan Dammerman, Paul Hodgkins, Mei Lu, Jipan Xie, Eric Q Wu
BACKGROUND: No head-to-head clinical trials have been published comparing guanfacine extended release (GXR) and atomoxetine (ATX): two nonstimulants approved for the treatment of attention-deficit/hyperactivity disorder (ADHD). However, other study designs or methods could be used to indirectly compare these two medications. Matching-adjusted indirect comparison (MAIC) is a recent methodology that utilizes individual patient data (IPD) from clinical trials for one treatment and published aggregate data from another treatment to estimate the relative efficacy of both, providing rapid, reliable comparative efficacy results...
November 2013: CNS Drugs
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