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WHO Pharmaceuticals Newsletter 2016 WHO Pharmaceuticals NEWSLETTER No.4 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 across No country left behind: worldwide pharmacovigilance the world. It also provides signals based on information for safer medicines, safer patients derived from Individual Case Safety Reports (ICSRs) available in the WHO Global ICSR database, VigiBase®. A brief report from the Thirteenth Meeting of the WHO The aim of the Newsletter is to Advisory Committee on Safety of Medicinal Products disseminate information on (ACSoMP) is included as a feature. the safety and efficacy 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, Contents World Health Organization, 1211 Geneva 27, Switzerland, E-mail address: [email protected] Regulatory matters This Newsletter is also available at: http://www.who.int/medicines Safety of medicines Signal Feature © World Health Organization 2016 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 Table of Contents Regulatory Matters Alpha lipoic acid ................................................................................. 5 Apixaban ........................................................................................... 5 Benzoyl peroxide ................................................................................ 5 Bisphosphonates ................................................................................ 5 Bromhexine-containing cough and cold medicines .................................. 6 Canagliflozin and dapagliflozin ............................................................. 6 Carmustine (intracerebral implant) ....................................................... 6 Diclofenac ......................................................................................... 7 Febuxostat ........................................................................................ 7 Fingolimod ......................................................................................... 7 Hydroxyzine ...................................................................................... 7 Idelalisib ........................................................................................... 8 Interferon beta-1a .............................................................................. 8 Lercanidipine ..................................................................................... 9 Levetiracetam .................................................................................... 9 Natalizumab ...................................................................................... 9 Nintedanib ....................................................................................... 10 Ombitasvir, paritaprevir and ritonavir combination ............................... 10 Oxytocin.......................................................................................... 10 Rivaroxaban, dabigatran and apixaban ................................................ 10 Sodium-glucose cotransporter-2 (SGLT2) inhibitors .............................. 11 Sofosbuvir ....................................................................................... 11 Vemurafenib .................................................................................... 11 Warfarin .......................................................................................... 12 Safety of Medicines Aspirin-containing over-the-counter antacid products ............................ 13 Canagliflozin .................................................................................... 13 Citalopram ....................................................................................... 13 Denosumab ..................................................................................... 13 Doxylamine and pyridoxine combination .............................................. 14 Etonogestrel implants (Nexplanon®) .................................................. 14 WHO Pharmaceuticals Newsletter No. 4, 2016 3 Table of Contents Loperamide ..................................................................................... 15 Marcain Spinal 0.5% Heavy® ............................................................ 15 Metformin ........................................................................................ 15 Miconazole (topical use including oral gel) ........................................... 16 Zecuity® (sumatriptan) migraine patch .............................................. 16 Signal Thiamazole and rhabdomyolysis ......................................................... 17 Feature Report from the Thirteenth Meeting of the WHO Advisory Committee on Safety of Medicinal Products (ACSoMP) ............................................... 23 WHO Pharmaceuticals Newsletter No. 4, 2016 4 Regulatory Matters Alpha lipoic acid Apixaban A total of seven cases of cutaneous symptoms with the Potential risk of low blood Risk of hepatic function use of benzoyl peroxide have sugar (hypoglycaemic disorder been reported in Japan. Of these, a causal relationship episodes) Japan. The Ministry of Health, could not be excluded in six Canada. Health Canada will Labour and Welfare (MHLW) cases. consider updating the labelling and the Pharmaceuticals and Following an investigation of standard for alpha lipoic acid Medical Devices Agency available evidence and advice to include advice on (PMDA) have announced that from experts, the MHLW/PMDA management of hypoglycaemic the package insert for concluded that revision of the episodes. This follows apixaban (Eliquis®) has been package insert was necessary. conclusions from a safety updated to include the risk of review of case reports and hepatic function disorder as a Reports on the cases of publications in the scientific clinically significant adverse erythema and swelling literature that indicate a risk of reaction. spreading to the entire face developing insulin autoimmune and neck will be added as a Apixaban is used to reduce the syndrome (IAS) with use of precaution to the package risk of ischemic stroke and alpha lipoic acid (medicinal insert. systemic embolism in people ingredient in natural health with non-valvular atrial Reference: products). fibrillation. It is also used for Revision of Precautions, Alpha lipoic acid is used as an treatment and prophylaxis of MHLW/PMDA, 5 July 2016 antioxidant to help promote relapse of venous (www.pmda.go.jp/english/) the breakdown of glucose, and thromboembolism (deep vein as a preservative in some thrombosis and pulmonary natural health products. embolism). Bisphosphonates At the time of the review, A total of 16 cases of hepatic Risk of osteonecrosis of there were no reports of function disorder with the use external auditory canal hypoglycaemic episodes of apixaban have been reported with the use of alpha reported in Japan. Of these, a Japan. The MHLW and the lipoic acid that originated from causal relationship could not PMDA have announced that the Canada. However, there were be excluded in five cases. package inserts for several published international Following an investigation of bisphosphonates (etidronate, case reports of hypoglycaemic available evidence and advice pamidronate, alendronate, episodes in individuals with from experts, the MHLW/PMDA risedronate, zoledronic acid, IAS which may have been concluded that revision of the minodronic acid and triggered by the use of oral package insert was necessary. ibandronate) have been products containing alpha
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