Paediatric News 09/08/06 Scottish Medicines Consortium (SMC) Accepts Invanz Paediatric (ertapenem) for Restricted use in Treatment of Intra-abdominal Infections in Children and Adolescents.   Source – National Electronic Library for Medicines – The Scottish Medicines Consortium (SMC) has advised NHS Boards and Area Drug and Therapeutic Committees (ADTCs) that ertapenem sodium infusion (Invanz™) Paediatric is accepted for restricted use within NHS Scotland for the treatment of Intra-abdominal infections in children and adolescents. 02/08/06 The Health Technology Assessment Publish a Systematic Review of Cost-Effectiveness of Methylphenidate, Dexamphetamine and Atomoxetine for ADHD in Children and Adolescents   Source – Druginfozone - The Health Technology Assessment (HTA) Programme has reviewed the clinical and cost-effectiveness of oral methylphenidate, dexamphetamine and atomoxetine in children and adolescents with ADHD (including hyperkinetic disorder). 31/07/06 European Medicines Agency Finalises Guideline on Pharmacovigilance for Medicines Used in Children   Source - The European Medicines Agency (EMEA) - The EMEA has finalised a guideline on the conduct of pharmacovigilance for medicines used by the paediatric population - children from birth to 18 years of age. This is the first guideline to focus exclusively on the issues of safety of medicines in children. 24/07/06 FDA Approves Oncaspar for Newly-Diagnosed Acute Lymphoblastic Leukaemia   Source - The Food and Drug Administration (FDA) - The Food and Drug Administration (FDA) has expanded the approved use of Oncaspar to include treating children and adults with newly diagnosed acute lymphoblastic leukaemia (ALL) as part of a multiple drug chemotherapy regimen. 10/07/06 Paediatric Inhalation Products   Source – Pharmaceutical Journal July 2006; 277 – A report in the Pharmaceutical Journals highlights the meeting of academics, industrialists and regulators who met to discuss unmet needs and the regulatory framework in the rapidly developing filed of paediatric inhalation technology. 10/07/06 PJ Online Information Link for Children/Baby Issues   Source – Pharmaceutical Journal July 2006; 277 -  PJ online has a link to information on breastfeeding , still birth and cot deaths, accident prevention and a continuing professional development series on pregnancy. 04/07/06 Abbott's New Tablet Formulation Of Kaletra(R) (lopinavir/ritonavir) Approved In Europe   Source -  MediLexicon – Abbott  has announced that it has received marketing authorisation from the European Commission for the tablet formulation of Kaletra(R) (lopinavir/ritonavir), a new, more convenient version of the leading protease inhibitor (PI) prescribed worldwide for the treatment of HIV. 03/07/06 Current Problems in Pharmacovigilance   Source – Medicines and Healthcare Products Regulatory Agency (MHRA) – Current problems in pharmacovigilance May 2006 volume 31 highlights the following drugs which are unlicensed for the use in paediatrics but are known to be prescribed off-label 03/07/06 Local Reactions Associated with Preschool d/DTaP-IPV Boosters   Source – The Medicines and Healthcare Products Regulatory Agency (MHRA) – Current problems in pharmacovigilance (Vol 31 May 2006) highlight that extensive limb swelling following d/DTaP IPV boosters is common but transient. 27/06/06 Lamotrigine and Risk of Oral Cleft during Early Pregnancy   Source – GlaxoSmithKline Health Care Professional Letter – New safety information has been issued regarding the increased risk of oral clefts associated with the use of Lamictal® (lamotrigine) during early pregnancy. 26/06/06 Anzemet (dolasetron mesilate) – New Contraindication in Children and Adolescents Under 18 Years   Source – Personnel communication from Amdipharm –Anzemet (dolasetron mesilate) only licensed for adults now has the following new contraindication added to the prescribing information that Dolasetron is contraindicated for use in children and adolescents less than 18 years. 26/06/06 Oral Montelukast Treatment of Children with Acute Asthma.   Source – Druginfozone – A study published in Annals of Allergy, Asthma and Immunology 2006; 96(5): 731-735 suggests that adding oral montelukast to inhaled beta-agonist therapy may be beneficial in acute asthma in pre-school children aged (2-5 years) 09/06/06 Clofarabine (Evoltra) Approved in EC for Treatment of Acute Lymphoblastic Leukaemia in Children   Source – Druginfozone -  The European Commission (EC) has approved Clofarabine (Evoltra™) for the treatment of acute lymphoblastic leukaemia in children who have relapsed or are refractory to at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. 09/06/06 European Regulation on Medicines for Children   Source – The Medicines and Healthcare products Regulatory Agency (MHRA) – An agreement has been reached on a European Regulation on medicines for children. The Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health (DH) have welcomed this agreement 07/06/06 European Medicines Agency (EMEA) Adopts a Positive Opinion for the use of Prozac in Children of 8 Years and Olde r.   Source – European Medicines Agency (EMEA) - The European Medicines Agency (EMEA) has recommended to extend the indication for Prozac (fluoxetine) and associated names to include the treatment of children of 8 years of age and over who suffer from moderate to severe depression and who do not respond to psychological therapy. 22/05/06 FDA Approves Remicade (infliximab) for Children with Crohn’s Disease   Source – The Food and Drug Administration (FDA) – The FDA has approved Remicade (infliximab) to treat children with active Crohn’s disease, a chronic, inflammatory condition of the bowel that can be severely debilitating 09/05/06 Online Calculator and Chemotherapy Order Systems Reduces Medication Errors in Paediatric Infusions   Source – Druginfozone – Two studies from the John Hopkins Children’s Centre in the United States shows that computerising ordering of chemotherapy and other types of intravenous drug infusions for children greatly reduces the risk of potentially dangerous medication errors. 02/05/06 NICE Issues Guidance on Immunosuppressive Therapy for Young Kidney Transplant Patients   Source – NICE – The National Institute for Health and Clinical Excellence has issued guidance on the use of immunosuppressive therapy for renal (kidney) transplantation in children and adolescents. 11/04/06 NHS Immunisation Information has Produced a DVD Video Highlighting the Importance of Immunisation in Protecting Children from Serious Diseases   Source – Department of Health - A free DVD on child immunisation aimed at parents and health care professionals is now available to order from the NHS Immunisation Information website. 11/04/06 The United States Food and Drug Administration (FDA) Approves Methylphenidate Patch to Treat Attention Deficit Hyperactivity Disorder (ADHD) in Children.   Source – The Food and Drug Administration – The Food and Drug Administration (FDA) has approved Daytrana, the first transdermal patch, for treating Attention Deficit Hyperactivity Disorder (ADHD) in children 6 to 12 years of age 31/03/06 The United States Food and Drug Administration Agency (FDA) Approves Relenza for Preventing Influenza in Adults and Children aged 5 and Over.   Source – Druginfozone – The United States Food and Drug Agency (FDA) has approved GlaxoSmithKline Relenza (zanamivir) for preventing influenza in adults and children aged 5 and over 27/03/06 Attention Deficit Hyperactivity Disorder (ADHD) - Methylphenidate, Atomoxetine and Dexamfetamine NICE Guidance – review)   Source – NICE guidance - The latest NICE guidance to be published in March 2006 includes guidance on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) with methylphenidate, atomoxetine and dexamfetamine. 27/03/06 European Medicines Agency (EMEA) Recommends Cautious use of Protopic (tacrolimus ointment) and Elidel (pimecrolimus cream)   Source – Druginfozone – A safety review has been finalised by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Protopic (tacrolimus ointment) and Elidel (pimecrolimus cream) following reports of skin cancer and lymphoma in patients who had used these products 27/03/06 Quick Reference Guides Issued by PRODIGY in March 2006   Source – Druginfozone - Nineteen quick reference guides (QRGs) were published on the PRODIGY website for March 2006 14/03/06 Antibiotic Use in Babies Increases Risk of Asthma in Childhood?   Source - NEW YORK (Reuters Health) – A report in Chest 2006; 129:610-618 suggests that exposure to antibiotics in the first year of life may increase the risk of developing asthma later in childhood. In fact, there may even be a higher risk with each additional course of antibiotics. 10/03/06 Pamidronate Benefits Limited in Children with Osteogenesis Imperfecta   Source –Medscape – An article published in The Journal of Clinical Endocrinology and Metabolism 2006; 91:511-516 reports that in children with osteogenesis imperfect, the value of pamidronate therapy appears to be restricted to the first few years of treatment 10/03/06 Final Appraisal Determination: Immunosuppressive Therapy for Renal Transplantation in Children and Adolescents   Source – National Institute for Health and Clinical Excellence (NICE) - The Appraisal Committee has prepared a Final Appraisal Determination (FAD) on Immunosuppressive therapy for renal transplantation in children and adolescents and submitted it to the Institute 07/03/06 Caution Advised for use of Konakion MM Paediatric for Intramuscular use in Neonates   Source – Druginfozone - According to an article in MIMS (March 2006), Konakion MM paediatric is now licensed for use intramuscularly (following discontinuation of Konakion Neonatal) for the treatment of vitamin K deficiency bleeding in healthy neonates of 36 weeks gestation or older 04/03/06 Childhood Obesity a Target for the Profession   Source – Pharmaceutical Journal 4/3/06 -  The Government's ability to fulfil its public service agreement (PSA) “to halt the increase in obesity among children under the age of 11 by 2010” has been called into question in a joint report published in March 2006 by the Audit Commission, the Healthcare Commission and the National Audit Office 04/03/06 Scottish Intrathecal Injection Guidance Published   Source – Pharmaceutical Journal 4/3/06 - Guidance on the safe handling of intrathecal and intraventricular injections in Scotland has been produced by the Scottish Executive Health Department. 28/02/06 Effects of the Committee on Safety of Medicines (CSM) Advice on Antidepressant Prescribing to Children and Adolescents   Source – Druginfozone - Research published in Drug Safety 2005; 28 (12): 1151-1157 reports that the rising prevalence of antidepressant prescribing for children and adolescents in primary care was significantly reversed following Committee on Safety of Medicines (CSM) advice on antidepressant prescribing for children and adolescents, issued in 2003. 28/02/06 Rotarix : First Vaccine Against Rotavirus Available in Europe   Source – Medscape - The European Commission has granted approval of RotarixTM in the European Union (EU), allowing active vaccination of infants from the age of 6 weeks, against the highly contagious rotavirus. RotarixTM will be the first vaccine available to children in Europe for the prevention of gastroenteritis caused by rotavirus 28/02/06 ‘Drug Doses’ Frank Shann 13th Edition 2005   Source – Correspondence from Frank Shann Feb 06 -The author has identified 7 errors in the reference text ‘Drug Doses’ Frank Shann 13th Edition 2005 21/02/06 Special Products Website   Source – Correspondence from Special Products Limited Feb 2006 – Special Products Limited have a new website. 16/02/06 Strattera (atomoxetine) - Conclusion of Risk: Benefit Review   Source Letter MHRA 16/2/06 - A letter from Professor G Duff, Chairman, Commission on Human Medicines dated 16/2/06, issues new advice to prescribers regarding the potential risk of seizure with Strattera and reports QT interval prolongation 14/02/06 Oral Protein Energy Supplements for Cystic Fibrosis Found to be of No Benefit   Source – Druginfozone - A multicentre randomised controlled trial published in BMJ February 2006 (published early online) has found that giving moderately malnourished children with cystic fibrosis (CF) long-term oral protein energy supplements does not seem to have any benefits. 14/02/06 Planned Changes to the Routine Childhood Immunisation Programme   Source –Department of Health Vaccine Update 120 Feb 2006 – This vaccine update 120 letter provides advance notice of the Department of Health’s plans to introduce important changes to the childhood immunisation programme that will start later this year (2006). 07/02/06 Tamiflu Gains Approval in Europe for Prevention of Influenza in Children Aged 1 to 12 Years   Source – Pharma-lexicon - Roche announced that its anti-influenza medicine Tamiflu (oseltamivir) has received approval from the European authorities for the prophylaxis of influenza in children aged one to 12 years 07/02/06 EMEA Approves IV Keppra (levetiracetam)   Source – Druginfozone - The European Medicines Agency (EMEA) has issued a positive opinion to approve marketing authorisation of Keppra® (levetiracetam) Concentrate (100 mg/mL) as an intravenous administration and for use as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults and children of four years of age and older with epilepsy. 23/01/06 Early Signs of Meningococcal Disease in Children and Adolescents   Source – Pharmaceutical Journal (14/1/06 volume 276) - A new study published online on 11 January 2006 in The Lancet identifies early warning signs for meningococcal sepsis in children and adolescents 20/01/06 Thornton & Ross Launch Hedrin 4% Lotion (dimethicone) for Head Lice   Source – Druginfozone - Thornton & Ross has launched Hedrin, a cutaneous solution containing 4% dimeticone w/w, for the eradication of head lice infestations in adults and children over 6 months. 23/12/05 FDA Approves Tamiflu for Prevention of Influenza in Children Under Age 12   Source – Food and Drug Administration (FDA) - The U.S. Food & Drug Administration (FDA) approved the use of Tamiflu (oseltamivir phosphate) for prevention (prophylaxis) of seasonal influenza ("flu") in children 1 to 12 years of age who had close contact with an infected individual. This is the first drug approved for prevention of both influenza A and B in pediatric patients 06/12/05 Flavours for Dispensed Medicines to be Marketed in the United Kingdom   Source - Pharmaceutical Journal - FLAVORx, a US company that markets flavourings for dispensed medicines, is to try to expand its business into the United Kingdom (UK). 30/11/05 US FDA Approves Oxcarbazepine (Trileptal) as Adjunctive Therapy for Epilepsy in Children Over 2 Years   Source – Druginfozone - Novartis Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has approved oxcarbazepine (Trileptal) tablets and oral suspension as adjunctive therapy in the treatment of partial seizures in children as young as two-years old with epilepsy 23/11/05 Health Protection Agency and OPi Pharmaceuticals Launch Drug to Help Children Fight Leukaemia   Source – Medical News Today - A life-saving drug which offers potential benefit to children with leukaemia who have become allergic to front line therapies is to be produced by the Health Protection Agency in partnership with OPi Pharmaceuticals. 23/11/05 New Guidelines Set to Improve Identification, Diagnosis and Treatment of Obsessive-Compulsive Disorder in Children and Adults   Source - The National Institute for Health and Clinical Excellence (NICE) - NICE and the National Collaborating Centre for Mental Health have launched a clinical guideline on the identification, treatment and management of obsessive-compulsive disorder (OCD) and body dysmorphic disorder (BDD) in children and adults. 18/11/05 FDA Approves First Oral Drug for Chronic Iron Overload   Source - The U.S. Food and Drug Administration (FDA) – The FDA has approved Exjade (deferasirox), an oral iron chelator developed to treat chronic iron overload due to multiple blood transfusions. 18/11/05 FDA Approves Intravenous Route for Oncaspar   Source – Medscape Medical News - The FDA has approved an intravenous route of administration for pegaspargase injection (Oncaspar, made by Enzon Pharmaceuticals, Inc.). The pediatric product was previously approved for delivery via intramuscular injection, which is often painful to patients. 18/11/05 Tamiflu Pediatric Adverse Events: Questions and Answers   Source – U. S. Food and Drug Administration – The United States Food and Drug Administration (FDA) has published questions and answers to Tamiful pediatric adverse events on its website. 08/11/05 A New Antibiotic Drug Delivery System for Children   Source – Pharmaceutical Journal (5/11/05) - A new antibiotic drug delivery system designed to improve compliance and dosing accuracy when administering drugs to children has been launched by Grünenthal 02/11/05 SIGN and British Thoracic Society Issue Updated Guideline on the Management of Asthma   Source – Druginfozone – The Scottish Intercollegiate Guidelines Network (SIGN), together with The British Thoracic Society has published the updated British guideline on the management of asthma (No. 63). 01/11/05 Positive Clinical Trial Results for Keppra® as Adjunctive Therapy in the Treatment of Primary Generalised Tonic-Clonic Seizures   Source – Medi-lexicon - UCB announced positive clinical trial results from a study eval