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2020 WHO Pharmaceuticals No.2 NEWSLETTER The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicines WHO Vision for Medicines Safety and legal actions taken by regulatory authorities around No country left behind: the world. It also provides signals based on information worldwide pharmacovigilance for safer medicines, safer patients derived from the WHO global database of individual case safety reports, VigiBase. This edition of the Newsletter also includes the The aim of the Newsletter is nd to disseminate regulatory recommendations from the 42 Annual Meeting of information on the safety of Representatives of National Pharmacovigilance pharmaceutical products, Centres participating in the WHO Programme for based on communications received from our network of International Drug Monitoring. Given the current national pharmacovigilance centres interest over the use of chloroquine and and other sources such as hydroxychloroquine in COVID-19, we have also specialized bulletins and journals, as well as partners in WHO. included a summary of case safety reports in Vigibase for these products. The information is produced in the form of résumés in English, full texts of which may be obtained on request from: Safety and Vigilance: Medicines, EMP-HIS, World Health Organization, 1211 Geneva 27, Switzerland, Contents E -mail address: [email protected] This Newsletter is also available at: Regulatory matters http://www.who.int/medicines Safety of medicines Signal Feature ISBN 978-92-4-000568-6 (electronic version) ISBN 978-92-4-000569-3 (print version) © World Health Organization 2020 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. WHO Pharmaceuticals Newsletter No.2, 2020. Geneva: World Health Organization; 2020. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. 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 WHO 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 and dashed 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 WHO 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 WHO 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 WHO be liable for damages arising from its use. Table of Contents Regulatory Matters Acitretin ................................................................................................................ 5 Alemtuzumab ........................................................................................................ 5 Allopurinol ............................................................................................................. 5 Aminolevulinic acid ............................................................................................... 5 Arsenic trioxide ..................................................................................................... 6 Cyproterone .......................................................................................................... 6 Direct-acting antivirals (DAAs)............................................................................... 6 Fluoroquinolone .................................................................................................... 7 Fluorouracil, capecitabine, tegafur......................................................................... 7 Fosravuconazole ................................................................................................... 7 Ingenol mebutate (gel) .......................................................................................... 7 Lorcaserin ............................................................................................................. 8 Montelukast .......................................................................................................... 8 Rotigotine ............................................................................................................. 8 Ulipristal acetate ................................................................................................... 9 Safety of medicines Clozapine ............................................................................................................ 10 Ferric carboxymaltose ......................................................................................... 10 Ifosfamide (solution) ............................................................................................ 10 Mecasermin ........................................................................................................ 10 Nitrofurantoin ...................................................................................................... 11 Ondansetron ....................................................................................................... 11 Information Note Chloroquine and hydroxychloroquine in COVID-19 .............................................. 12 Signal Agomelatine and Increased Blood Pressure ........................................................ 14 Midostaurin – photosensitivity reaction ................................................................ 19 Tramadol and hyperacusis .................................................................................. 24 Feature Recommendations from the 42nd Annual Meeting of Representatives of the WHO Pharmaceuticals Newsletter No. 2, 2020 • 3 Table of Contents National Pharmacovigilance Centres Participating in the WHO Programme for International Drug Monitoring .............................................................................. 32 WHO Pharmaceuticals Newsletter No. 2, 2020 • 4 Regulatory Matters Acitretin The review concluded that hypertension accompanied by serious cardiovascular hyperuricemia. reactions can rarely occur Changes to pregnancy Although no cases involving within one to three days of prevention requirements aseptic meningitis have been treatment. However reported in patients taking unpredictable and potentially New Zealand. Acitretin is allopurinol in Japan during the fatal immune-mediated used to treat several skin previous three years, reactions can occur within conditions including psoriasis. considering that cases were months and up to at least four Acitretin is teratogenic and is reported overseas the MHLW years post-treatment. This contraindicated in women of and PMDA have determined included Epstein-Barr virus childbearing potential unless all that the revision was reactivation. of the conditions of the necessary. Pregnancy Prevention Alemtuzumab should only be Reference: Programme are met. used as a single disease- Revision of Precautions, modifying therapy in adults Medsafe has announced that MHLW/PMDA, 25 February with specific conditions. the period during which 2020 (www.pmda.go.jp/english/) effective contraception must be Alemtuzumab is used has increased from two to contraindicated in patients with severe active infection until three years after the end of treatment with acitretin complete resolution, those with (Novatretin®). a history of stroke and a history of angina. Aminolevulinic
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