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WHO Pharmaceuticals Newsletter No. 2, 2018 • 3 Table of Contents 2018 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: worldwide pharmacovigilance the world. It also provides signals based on information for safer medicines, safer patients derived from the WHO global database of individual case safety reports, VigiBase. This newsletter includes a feature article titled PV The aim of the Newsletter is to disseminate regulatory strengthening in Armenia and Kyrgyzstan using smart information on the safety of safety surveillance approach; identifying gaps. pharmaceutical products, based on communications received from our network of national pharmacovigilance centres and other sources such as specialized bulletins and journals, as well as partners in WHO. 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 © World Health Organization 2018 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. 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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. Printed in Switzerland Table of Contents Regulatory Matters Antihistamines (first generation, oral sedating) ........................................ 5 Clarithromycin ..................................................................................... 5 Clopidogrel and selexipag interaction ...................................................... 5 Daclizumab beta .................................................................................. 5 Dipeptidylpeptidase-4 inhibitors ............................................................. 6 Efavirenz............................................................................................. 6 Flupirtine ............................................................................................ 6 Gadolinium-containing contrast agents ................................................... 7 Hydroxyethyl-starch solution ................................................................. 7 Iohexol, Iomeprol ................................................................................ 7 Kampo medicines containing Gardenia fruit ............................................. 8 Miconazole and warfarin interaction ........................................................ 8 Mycophenolate mofetil, mycophenolic acid .............................................. 8 Radium-223 dichloride .......................................................................... 8 Retinoids ............................................................................................. 9 Sterile talc .......................................................................................... 9 Tolvaptan ............................................................................................ 9 Safety of medicines Artemisia annua extract in grape seed oil .............................................. 10 Aspirin in chloroform .......................................................................... 10 Clozapine .......................................................................................... 10 Dabigatran ........................................................................................ 10 Direct-acting antivirals (DAAs) ............................................................. 11 Eribulin ............................................................................................. 11 Idarucizumab .................................................................................... 11 Ruxolitinib ......................................................................................... 11 Sodium-glucose Cotransporter-2 (SGLT2) inhibitors ............................... 12 Suvorexant ....................................................................................... 12 Ulipristal acetate ................................................................................ 12 WHO Pharmaceuticals Newsletter No. 2, 2018 • 3 Table of Contents Signal Artemether/Lumefantrine and Stevens-Johnson syndrome: a recommendation for continued vigilance in malaria-endemic areas ........... 14 Quetiapine and valproic acid interactions: signal strengthening ................ 19 Feature Enhancing Pharmacovigilance in Low and Middle Income Countries using Smart Safety Surveillance ................................................................... 26 WHO Pharmaceuticals Newsletter No. 2, 2018 • 4 Regulatory Matters Antihistamines (first Clarithromycin Selexipag is indicated for pulmonary arterial generation, oral Potential risk of heart hypertension. Clopidogrel is sedating) problems or death in indicated for suppression of recurrent ischemic patients with heart disease Potential for fatal cerebrovascular disorder. respiratory depression in USA . The US Food and Drug Clopidogrel is a potent CYP2C8 children under two years of Administration (FDA) has inhibitor and there is a age added a new warning about an possibility of an onset of increased risk of death in adverse drug reactions and/or Australia . The Therapeutic patients with heart disease to symptom exacerbation arising Goods Administration (TGA) the drug labels for from an increase in blood will work with manufacturers to clarithromycin (Baxin®). In concentrations of selexipag and strengthen warnings in the addition, the FDA has added its active metabolite. MHLW product information (PI) and the results of a clinical trial that and PMDA have conducted an consumer medicine information indicate this increased risk to investigation and have (CMI) for first generation oral clarithromycin drug labels. concluded that the revision of antihistamines, to emphasize Clarithromycin is used to treat the package inserts of both that they should not be used in a variety of infections and is products should include children under two years of age not approved to treat heart language regarding the risks due to the potential risk disease. associated with co- respiratory depression. In administration of clopidogrel. addition, TGA will be seeking to The FDA’s recommendation is Reference: include a mandatory warning based on a review of the Revision of Precautions, statement on labels of over- results of a 10-year follow-up MHLW/PMDA,
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