No. 3, 2008 NEWS & ISSUES This issue has been delayed considerably on account of some of our support staff leaving the unit, and due to teething difficulties with an all new global resource management system in WHO. But things are slowly getting back on track and we apologize for the inconvenience to our readers. Some of the information in this issue may be a bit old but we thought it would be useful to record them nevertheless, as a way of archiving the information for your future reference. Thank you for your continuing interest. Contents Regulatory matters Safety of medicines Features © World Health Organization 2008 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 Conventional antipsychotics...................................................................................... 1 Becaplermin ........................................................................................................... 1 Epoetins ................................................................................................................ 1 Etanercept ............................................................................................................. 1 Etoricoxib .............................................................................................................. 2 Fluoroquinolones..................................................................................................... 2 Label changes for use in pregnancy ........................................................................... 2 Moxifloxacin ........................................................................................................... 2 Norfloxacin............................................................................................................. 3 Pegvisomant-somatostatin analogues ........................................................................ 3 Perflutren injectable suspension ................................................................................ 3 Rotavirus gastroenteritis vaccine ............................................................................... 4 ADR reporting in Finland .......................................................................................... 4 Safety of Medicines Abacavir and abacavir-containing medications............................................................. 5 Abacavir and abacavir-containing medications............................................................. 5 BCG vaccine........................................................................................................... 5 Clozapine............................................................................................................... 5 Fluorescein ............................................................................................................ 6 Fluticasone propionate............................................................................................. 6 Nitrofurantoin......................................................................................................... 6 Pioglitazone ........................................................................................................... 7 Rimonabant ........................................................................................................... 7 Risperidone, pipamperone ........................................................................................ 7 Salbutamol ............................................................................................................ 8 Statins .................................................................................................................. 8 Strontium ranelate .................................................................................................. 8 TNF antagonists...................................................................................................... 8 Varencicline ........................................................................................................... 9 Risk evaluation and mitigation studies (REMS) ............................................................ 9 FDA Sentinel Initiative ............................................................................................. 9 Feature Review of Oseltamivir Reports in Vigibase is reassuring but vigilance for hepatic and skin disorders recommended......................................................................................... 10 REGULATORY MATTERS mortality in patients who have venous thromboembolism and Conventional used three or more tubes of the shorter overall survival in product. Becaplermin is mainly cancer patients who received antipsychotics used to heal wounds in patients epoetins compared to patients Boxed warnings on with diabetes. This action who did not receive them. fatalities in elderly follows the Agency's review of patients safety data from a retrospective Reference: study showing a five-fold EMEA Press Release, increased risk of cancer 26 June 2008 USA. The United States Food mortality in patients exposed to (www.emea.europa.eu). and Drug Administration (US three or more tubes of FDA) is requiring manufacturers becaplermin (see WHO of conventional antipsychotics Pharmaceuticals Newsletter to add Boxed Warnings about Etanercept No. 2, 2008). The US FDA the increased risk of death in cautions health-care Label to indicate risk of elderly patients treated for professionals to carefully weigh infections in children dementia-related psychosis. the risks and benefits of The FDA based this requirement treating patients with USA. The US FDA's on recent studies together with becaplermin. Dermatologic and Ophthalmic earlier evidence for atypical Drugs Advisory Committee is antipsychotics, that both recommending that labelling for atypical and conventional Reports in WHO ICSR database: Amgen's etanercept (Enbrel) antipsychotics have an include warnings that use of the increased risk of death in Total 58 reports, 2004 – 2008 agent in paediatric patients elderly patients with dementia- all from USA: may lead to moderate to severe related psychosis. infections and can result in Melanoma malignant 1 death. Manufacturers of antipsychotics Adenocarcinoma NOS 1 are being asked to update Pulmonary carcinoma 1 The committee recommended labelling so that all drugs have Skin hypertrophy 55 the following labelling changes: the same warnings. • Under the 'Adverse Reference: Reactions in Patients with The FDA advises health-care Becaplermin Information, Juvenile Idiopathic professionals that: US FDA, 6 June 2008 Arthritis' section, the • antipsychotics are not (www.fda.gov). wording should be approved for treatment of changed to reflect that dementia-related use of etanercept therapy psychosis in the paediatric • physicians who prescribe population may lead to antipsychotics to elderly Epoetins moderate to severe patients with dementia- Warning for use in cancer infections and can result related psychosis should patients in serious outcomes, discuss the increased including death and mortality risk with their Europe. European Medicines hospitalisation. patients, patients' families Agency (EMEA) has • In the same section, the and caregivers. recommended updating the list of serious adverse product information for epoetin- events reported in the Reference: containing medicines with a postmarketing period Media Release, FDA, new warning for their use in should be updated to 16 June 2008 (www.fda.gov). cancer patients stating that include macrophage blood transfusion should be the activation syndrome, preferred method of correcting malignancies, diabetes anaemia in patients suffering mellitus and systemic Becaplermin cancer. lupus erythematosus. Boxed warning added Epoetin-containing medicines Reference: about increased cancer are indicated in patients with Media