2015 WHO Pharmaceuticals NEWSLETTER No.6 Prepared in collaboration with the WHO Collaborating Centre for International Drug Monitoring, Uppsala Sweden The WHO Pharmaceuticals Newsletter provides you The aim of the Newsletter is to with the latest information on the safety of medicines disseminate information on the and legal actions taken by regulatory authorities across safety and efficacy of pharmaceutical products, based on the world. It also includes write-ups on ‘Signals’ from communications received from our Individual Case Safety Reports (ICSRs) available in the network of "drug information WHO Global ICSR database, VigiBase®. officers" and other sources such as specialised bulletins and journals, This newsletter includes three feature articles as well as partners in WHO. describing: the 38th meeting of the WHO International Working Group for Drug Statistics Methodology; Pre- The information is produced in the conference Workshop on WHO ATC/DDD Methodology form of résumés in English, full and Drug Utilization Research; and the 38th Annual texts of which may be obtained on Meeting of Representatives of the National request from: Pharmacovigilance Centres participating in the WHO Safety and Vigilance, Programme for International Drug Monitoring. EMP-HIS, 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/medicines Further information on adverse Contents reactions may be obtained from the WHO Collaborating Centre for International Drug Monitoring Box 1051 Regulatory matters 751 40 Uppsala Tel: +46-18-65.60.60 Safety of medicines Fax: +46-18-65.60.80 E-mail: [email protected] Signal Internet: http://www.who-umc.org Feature © World Health Organization 2015 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]). 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Printed by the WHO Document Production Services, Geneva, Switzerland Table of Contents Regulatory Matters Aripiprazole ....................................................................................... 5 Asunaprevir and daclatasvir ................................................................. 5 Azithromycin ...................................................................................... 5 Ceftriaxone ........................................................................................ 6 Clopidogrel ........................................................................................ 6 Codeine ............................................................................................. 6 Dipeptidyl peptidase-4 (DPP-4) Inhibitors .............................................. 7 Dutasteride ........................................................................................ 7 Galantamine ...................................................................................... 7 Hepatitis C treatments (Viekira Pak® and Technivie®) ........................... 7 Iodine-containing contrast agents for medical imaging ............................ 8 Magnesium oxide ............................................................................... 8 Mirabegron ........................................................................................ 8 Roxithromycin .................................................................................... 9 Sodium glucose co-transporter 2 (SGLT2) inhibitors ............................... 9 Strontium ........................................................................................ 10 Testosterone .................................................................................... 10 Ustekinumab ................................................................................... 11 Vemurafenib .................................................................................... 11 Safety of medicines Crizotinib ......................................................................................... 12 Entacapone...................................................................................... 12 Infliximab ........................................................................................ 12 Newer rotavirus vaccines (Rotarix® and RotaTeq®) ............................. 13 Sodium glucose co-transporter 2 (SGLT2) inhibitors ............................. 13 Sodium polystyrene sulfonate ............................................................ 14 Tramadol ......................................................................................... 14 Vemurafenib .................................................................................... 14 WHO Pharmaceuticals Newsletter No. 6, 2015 3 Table of Contents Signal Atomoxetine and neutropenia in paediatric patients .............................. 16 Deferasirox and pancreatitis in paediatric patients ................................ 20 Desloratadine and aggressive reaction ................................................ 25 Feature The 38th meeting of the WHO International Working Group for Drug Statistics Methodology, Oslo, 22–23 October 2015 ............................... 32 Pre-conference Workshop on WHO ATC/DDD Methodology and Drug Utilization Research, New Delhi, India, 2-3 November 2015. .................. 33 The 38th Annual Meeting of Representatives of the National Pharmacovigilance Centres participating in the WHO Programme for International Drug Monitoring ............................................................ 34 WHO Pharmaceuticals Newsletter No. 6, 2015 4 Regulatory Matters Aripiprazole information involving Reference: aripiprazole to investigate Revision of Precautions, Risk of certain impulse potential harms. MHLW/PMDA, 20 October 2015 (www.pmda.go.jp/english/) control behaviours Reference: Summary Safety Review, Canada. Health Canada has Health Canada, 2 November updated the Canadian 2015 (www.hc-sc.gc.ca) prescribing information for Azithromycin aripiprazole (Abilify®) to include a warning statement of Risk of drug reaction risk of pathological gambling Asunaprevir and with eosinophilia and and uncontrollable sexual systemic symptoms behaviours (hypersexuality). daclatasvir (DRESS) Aripiprazole is an oral medication and is used to Risk of interstitial Singapore. The Health treat: pneumonia Sciences Authority (HSA) has manic-depressive illness informed health-care (bipolar I disorder) in adults Japan. The Ministry of Health, professionals of the risk of and adolescents of 13 years Labour and Welfare (MHLW) eosinophilia and systemic and older. This condition is and the Pharmaceuticals and symptoms (DRESS) associated characterised by periods of Medical Devices Agency with the use of azithromycin. elevated moods (mania) (PMDA) have announced the Azithromycin (Zithromax®) is and depression; revision of the package insert a macrolide antibiotic (azalide schizophrenia in adults and for asunaprevir (Sunvepra®) subclass) used to treat upper adolescents of 15 years and and daclatasvir (Daklinza®) to and lower respiratory tract older; include risk of interstitial infections and other infections depression in adults when pneumonia. sensitive to azithromycin. used in combination with Asunaprevir and daclatasvir other drugs. are co-administered for In April 2014, Health Canada updated package inserts (PI) Health Canada conducted a treatment of serogroup 1 of azithromycin-containing safety review following the (genotype 1) chronic hepatitis products to include information European Medicines Agency C or compensated cirrhosis on DRESS. This was based on (EMA)’s warning (product label type C. a report of DRESS suspected update) of the risk of The MHLW/PMDA stated that to be associated with pathological gambling and the cases of interstitial pneumonia azithromycin in Canada, and a inclusion of hypersexuality as have been reported in patients review of published literature. an adverse effect. treated with asunaprevir and To date, the HSA has not At the time of the review, daclatasvir in Japan.