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Contents Regulatory Matters Safety of Medicines Prepared in collaboration with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden The aim of the Newsletter is to No. 5, 2014 disseminate information on the safety and efficacy of pharmaceutical products, The WHO Pharmaceuticals Newsletter provides you with based on communications received the latest information on the safety of medicines and from our network of "drug legal actions taken by regulatory authorities across the information officers" and other world. It also provides signals from the Uppsala sources such as specialized Monitoring Centre's SIGNAL document. bulletins and journals, as well as partners in WHO. The information In addition to the usual features, this issue includes the is produced in the form of résumés summary of discussions from the eleventh meeting of in English, full texts of which may the WHO Advisory Committee on Safety of Medicinal be obtained on request from: Products (ACSoMP). Safety and Vigilance, 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 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 Signal Feature © World Health Organization 2014 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 WHO Pharmaceuticals Newsletter No. 5, 2014 2 TABLE OF CONTENTS Regulatory Matters Bupropion ....................................................................................... 4 Diclofenac ...................................................................................... 4 Methylphenidate .............................................................................. 5 Omalizumab ................................................................................... 5 Topiramate ..................................................................................... 5 Valproate ....................................................................................... 6 Safety of Medicines Azathioprine ................................................................................... 7 Bo Ying Compound ® ....................................................................... 7 Bromocriptine ................................................................................. 7 Denosumab .................................................................................... 8 Ferumoxytol ................................................................................... 8 Measles, Mumps, Rubella, Varicella vaccine (MMRV) ........................... 8 Nitrofurantoin ................................................................................. 9 Zolpidem ........................................................................................ 9 Signal Febuxostat and Cardiac Failure ........................................................ 11 Pamidronic acid and Optic Neuritis ................................................... 18 Fingolimod and Twave Inversion...................................................... 21 Feature Eleventh Meeting of the WHO Advisory Committee on Safety of Medicinal Products (ACSoMP)...................................................................... 27 WHO Pharmaceuticals Newsletter No. 5, 2014 3 REGULATORY MATTERS Bupropion It is recommended that blood year. This information was pressure be monitored while derived from trials involving the patient is taking bupropion, long-term (more than 28 days) Serious cardiovascular especially in patients with pre- treatment with high-dose adverse events existing hypertension, and diclofenac (150 mg/day). consideration be given to To minimise risks, the lowest Australia. The Therapeutic discontinuing treatment if a effective daily dose should be Goods Administration (TGA) clinically significant increase is used for the shortest duration informs that the Product observed. Information for bupropion is necessary to control symptoms. A higher rate of hypertension being updated to provide Patients with cardiovascular has been observed when further information about the disease or other risk factors treatment with bupropion is risk of serious cardiovascular may be at greater risk. The combined with use of nicotine adverse events. TGA is undertaking a review of transdermal system products all NSAIDs with regards to Bupropion is a selective (patches). inhibitor of the neuronal their association with reuptake of catecholamines, If bupropion is used in cardiovascular risk. combination with nicotine noradrenaline and dopamine. It Reference: Medicine Safety patches, caution must be is registered for use in Update. August 2014. exercised and weekly Australia as a short-term (www.tga.gov.au) adjunctive therapy, used in monitoring of blood pressure is conjunction with counselling recommended. and abstinence, for nicotine Reference: Medicine Safety Risk of Major Heart and dependence to assist in Update. October 2014. Stroke Related Adverse smoking cessation. (www.tga.gov.au) Events The Product Information (PI) for bupropion had previously Canada. Health Canada has reviewed the safety of contained information Diclofenac regarding hypertension. diclofenac and has found that However, the TGA has diclofenac is associated with an increased risk of heart and identified postmarket Arteriothrombotic events spontaneous reports of more stroke related adverse events serious cardiovascular events, Australia. The TGA informs that is comparable to COX-2 including myocardial infarction. that the Product Information inhibitors, and that this risk To address this, the TGA is documents for prescription- should be considered when working closely with the only diclofenac have been prescribing or taking diclofenac. manufacturer to update and updated to provide further Health Canada informs that the strengthen the precautions for information about the overall benefits of diclofenac serious cardiovascular adverse increased risk of continue to outweigh the risks, events in the PI. arteriothrombotic events. when used as recommended. The updated information will Diclofenac is a non-steroidal However, in order to further advise that there have been anti-inflammatory drug reduce the risks associated reports of patients receiving (NSAID). Prescription-only with diclofenac, additional bupropion (alone and in products are available in oral information is being added to combination with nicotine and rectal forms. the prescribing information for replacement therapy) Information regarding diclofenac-containing products, experiencing severe arteriothrombotic events was which includes: hypertension requiring acute previously included in the treatment, in patients both precaution and adverse Specifying that with and without pre-existing reaction sections of the Product diclofenac at a higher dose hypertension. Information (PI). However, the (150 mg per day) is associated The updated information will updated PI includes details with an increased risk of heart also advise that there is limited from meta-analyses of and stroke related adverse clinical experience establishing individual participant data from events that is comparable to the safety of bupropion in randomised trials by the Coxib COX-2 inhibitors. patients with a recent history and traditional NSAID Trialists' Reducing the maximum of myocardial infarction or Collaboration that estimated, in daily dose for diclofenac from unstable heart disease. comparison with placebo, use 150 mg to 100 mg for all Therefore, health professionals of diclofenac caused about indications, excluding should exercise care if using three additional major vascular VOLTAREN RAPIDE which bupropion
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