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Pharmnewsletter6 11.Pdf prepared in collaboration with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden The aim of the Newsletter is to No. 6, 2011 disseminate information on the safety and efficacy of pharmaceutical products, based on communications received The WHO Pharmaceuticals Newsletter provides you with from our network of "drug the latest information on the safety of medicines and information officers" and other legal actions taken by regulatory authorities across the sources such as specialized world. Recent events and topics of concern are bulletins and journals, as well as addressed in the Feature section. This issue includes a partners in WHO. The information brief summary of a training course on the active is produced in the form of résumés monitoring of the safety of antiretroviral medicines. in English, full texts of which may be obtained on request from: Quality Assurance and Safety: Medicines, EMP-HSS, World Health Organization, 1211 Geneva 27, Switzerland, E-mail address: [email protected] This Newsletter is also available on our Internet website: http://www.who.int/medicine s Further information on adverse reactions may be obtained from the WHO Collaborating Centre for International Drug Monitoring Box 1051 751 40 Uppsala Tel: +46-18-65.60.60 Fax: +46-18-65.60.80 E-mail: [email protected] Internet: http://www.who-umc.org Contents Regulatory matters Safety of medicines Feature © World Health Organization 2011 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for non-commercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e- mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Printed by the WHO Document Production Services, Geneva, Switzerland TABLE OF CONTENTS Regulatory Matters Atomoxetine................................................................................... 4 Buflomedil-containing medicines ....................................................... 4 Dasatinib ....................................................................................... 5 Drotrecogin alfa (activated).............................................................. 5 Drospirenone-containing combined oral contraceptives ........................ 5 Fenofibric acid ................................................................................ 6 Fluoroquinolone .............................................................................. 6 Lenalidomide .................................................................................. 7 Modafinil ........................................................................................ 7 Pioglitazone.................................................................................... 8 Rosiglitazone .................................................................................. 8 Safety of medicines Angiotensin II receptor antagonists ................................................... 9 Buccal midazolam ........................................................................... 9 Citalopram ..................................................................................... 9 Linezolid ...................................................................................... 10 Methylene Blue ............................................................................. 10 Pholcodine.................................................................................... 11 Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine............................................................................. 11 Feature A training course on Cohort Event Monitoring of medicines used in HIV treatment programmes ........................................................ 12 WHO Pharmaceuticals Newsletter No. 6, 2011 • 3 REGULATORY MATTERS atomoxetine is started, after EMA advised patients using Atomoxetine the dose is increased, and buflomedil-containing periodically during treatment medicines to make an to detect possible clinically appointment with their doctor Association with important increases, at a convenient time to discuss increased blood pressure particularly during the first few their ongoing treatment. and heart rate months of therapy. The CHMP considered all Canada. Eli Lilly Canada Inc. (See WHO Pharmaceuticals available data on the benefits in collaboration with Health Newsletter No. 2, 2006 for new and risks of buflomedil, Canada informed of important recommended warnings in UK). including the benefit-risk information from clinical assessment carried out by Reference: studies regarding the risk of France, data from clinical increased blood pressure and Advisories, Warnings and studies, post-marketing heart rate with the use of Recalls, Health Canada, surveillance and published atomoxetine (Strattera®). The 21 October 2011 literature, as well as from monograph has recently been (www.hc-sc.gc.ca ). poison control centres in the revised to include these new EU. safety findings. Atomoxetine is a selective norepinephrine Following review of these data reuptake inhibitor indicated for Buflomedil- the Committee concluded that: • there was a risk of serious treatment of Attention- containing Deficit/Hyperactivity Disorder neurological and cardiac side (ADHD) in children and adults. medicines effects in patients taking buflomedil under normal conditions of use and that risk Recommendations are: Suspension of all • Atomoxetine is minimization measures such as buflomedil-containing contraindicated in patients with changes to the packaging of symptomatic cardiovascular medicines recommended the medicine, diseases, moderate to severe recommendations on adjusting hypertension or severe Europe. The European the dose for patients with cardiovascular disorders whose Medicines Agency (EMA)’s kidney problems and condition would be expected to Committee for Medicinal restrictions on the medicines’ deteriorate if they experienced Products for Human Use use in certain patients had not increases in blood pressure or (CHMP) concluded a review of been able to reduce these risks in heart rate that could be the safety and efficacy of to an acceptable level; clinically important; buflomedil, stating that the • due to the narrow • Atomoxetine should be risks of these medicines, therapeutic index (i.e. the used with caution in patients particularly the risks of severe small difference between whose underlying medical cardiological and neurological buflomedil’s therapeutic dose conditions could be worsened adverse reactions, are greater and its toxic dose) there was a by increases in blood pressure than their limited benefits in significant risk of adverse or heart rate, such as patients the treatment of patients with events, particularly in elderly with hypertension, tachycardia, chronic peripheral arterial patients and in patients with or cardiovascular or occlusive disease (PAOD). The certain conditions such as cerebrovascular disease; Committee therefore kidney problems, which are • Atomoxetine should be recommended that the common in PAOD; used with caution in patients marketing authorisations of all • data in support of the with congenital or acquired buflomedil-containing benefit of the medicine for long QT syndrome or a family medicines be suspended in all patients were limited and of history of QT prolongation; European Union (EU) Member poor quality. • patients should be States where they are screened for pre-existing or currently authorized. The Committee was therefore underlying cardiovascular or of the opinion that the benefits cerebrovascular conditions The EMA advised that doctors of buflomedil-containing before initiation of treatment should stop using buflomedil medicines do no longer with atomoxetine and and consider alternative outweigh their risks, and monitored during the course of treatment options, including recommended that marketing treatment; managing underlying health of these medicines should be • it is recommended that problems which can increase suspended throughout the EU. heart rate and blood pressure the risk of PAOD, such as be measured in all patients diabetes, high blood
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