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WHO Pharmaceuticals 2021 WHO Pharmaceuticals No.3 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. The aim of the Newsletter is to disseminate regulatory information on the safety of 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 WHO Pharmaceuticals Newsletter No. 3, 2021 ISBN 978-92-4-003128-9 (electronic version) ISBN 978-92-4-003129-6 (print version) © World Health Organization 2021 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 (http://www.wipo.int/amc/en/mediation/rules/). Suggested citation. WHO Pharmaceuticals Newsletter No. 3, 2021. Geneva: World Health Organization; 2021. 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 Atezolizumab ........................................................................................................ 4 Cetuximab (genetic recombination) ....................................................................... 4 COVID-19 vaccine NRVV Ad (ChAdOx1 nCoV-19) ................................................ 4 COVID-19 vaccine NRVV Ad26 (JNJ 78436735) ................................................... 4 Durvalumab (genetic recombination) ..................................................................... 5 Iopamidol .............................................................................................................. 5 Levothyroxine (tablet) ............................................................................................ 5 Nivolumab ............................................................................................................. 5 Obeticholic acid ..................................................................................................... 6 Polyethylene glycol (PEG) laxatives and starch-based thickeners ......................... 6 Pomalidomide, thalidomide ................................................................................... 6 Ritodrine and Magnesium sulfate (co-administration) ............................................ 7 Shosaikotokakikyosekko ....................................................................................... 7 Tozinameran ......................................................................................................... 7 Vascular endothelial growth factor (VEGF) inhibitors (systemic use) ..................... 7 Safety of medicines Amitriptyline .......................................................................................................... 9 Bendamustine ....................................................................................................... 9 Clonidine ............................................................................................................... 9 Clopidogrel ............................................................................................................ 9 Donepezil ............................................................................................................ 10 Fluoroquinolones ................................................................................................ 10 Indapamide ......................................................................................................... 10 Lamotrigine ......................................................................................................... 11 Nivolumab ........................................................................................................... 11 Theophylline ....................................................................................................... 11 Tozinameran, COVID-19 vaccine mRNA (mRNA 1273) ....................................... 11 Signal Levetiracetam and Hypokalaemia ........................................................................ 12 Remdesivir and pancreatic toxicity ...................................................................... 16 Tocilizumab and Pancreatitis ............................................................................... 22 WHO Pharmaceuticals Newsletter No. 3, 2021 3 Regulatory Matters Atezolizumab reported in patients treated (www.ema.europa.eu) with cetuximab in Japan in the (See also WHO Pharmaceuticals Newsletter Risk of severe cutaneous past three years, including No.2, 2021: Possible link to very rare cases adverse reactions (SCAR) three cases for which a causal of unusual blood clots with low blood relationship between the drug platelet counts in Europe) and event was assessed to be Malaysia. The National Pharmaceutical Regulatory reasonably possible. No patient Agency (NPRA) has announced mortalities have been reported. WHO, Global Advisory Committee on Vaccine Safety that the product information The MHLW and the PMDA (GACVS) review of latest for atezolizumab (Tecentriq®) concluded that the revision of evidence of rare adverse blood has been updated to include the package insert was coagulation events with the risk of severe cutaneous necessary. adverse reactions (SCAR). AstraZeneca COVID-19 Vaccine Reference: (Vaxzevria and Covishield), 16 Atezolizumab is indicated to Revision of Precautions, April 2021. treat non-small cell lung MHLW/PMDA, 30 March 2021 (https://www.who.int/news/item/16- cancer, small cell lung cancer (www.pmda.go.jp/english/) 04-2021-global-advisory-committee- and triple-negative breast on-vaccine-safety-(gacvs)-review- cancer. SCARs include acute of-latest-evidence-of-rare-adverse- generalized exanthematous blood-coagulation-events-with- pustulosis (AGEP), Stevens- astrazeneca-covid-19-vaccine- Johnson syndrome (JSJ), toxic COVID-19 vaccine (vaxzevria-and-covishield)) epidermal necrolysis (TEN) and drug rash with eosinophilia and NRVV Ad (ChAdOx1 systemic symptoms (DRESS). nCoV-19) Based on analysis from the COVID-19 vaccine company’s global safety data Risk of thrombosis with 99 cases of SCARs
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