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Who Pharmaceuticals Newsletter WHO PHARMACEUTICALS NEWSLETTER prepared in collaboration with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden The aim of this Newsletter is to No. 4, 2005 disseminate information on the safety and efficacy of pharmaceutical products, based on information received from our network of “drug information officers” and other sources such as specialized bulletins News & Issues and journals, as well as partners in WHO. The information is produced This issue comes to you close on the heels of the recently in the form of résumés in English, concluded Annual meeting of national pharmacovigilance full texts of which may be obtained centres here in Geneva. Over forty countries were on request from: represented, with the WHO venue providing the perfect opportunity to promote pharmacovigilance within several Quality Assurance and Safety: Medicines, PSM–HTP public health programmes: of interest were the interactions World Health Organization, with HIV /AIDS, malaria, helminths and the tuberculosis 1211 Geneva 27, Switzerland programmes. Working group exercises on these topics and E-mail address: [email protected] the sessions on vaccines, patient safety, and classification systems highlighted the future trends and issues in This newsletter is also available on our Internet website: pharmacovigilance. The guest lecture 'Patient safety: a http://www.who.int/medicines global challenge' by Sir Liam Donaldson, Chief Medical Officer, United Kingdom and Chair of the World Alliance for Further information on adverse Patient Safety, was significant in highlighting the common reactions may be obtained from the concerns across professions in promoting patient care. It is WHO Collaborating Centre for International Drug Monitoring, clear that future efforts will have to build on collaborations, Stora Torget 3, given the widening scope and expanding role of 753 20 Uppsala, Sweden pharmacovigilance. We take the opportunity to thank all the Tel: 46-18-65.60.60 participants for their enthusiasm and active participation Fax: 46-18-65.60.80 while summarizing the recommendations from three of the E-mail: [email protected] working group exercises. Internet:http://www.who-umc.org _________________________ Contents Regulatory matters Safety of medicines Feature © World Health Organization 2005 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 2476; fax: +41 22 791 4857; email: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; email: [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 WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either express 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. This publication contains the collective views of an international group of experts and does not necessarily represent the decisions or the stated policy of the World Health Organization. TABLE OF CONTENTS Regulatory Matters Amfetamine -- Reintroduced with revised prescribing and patient information ............................... 1 Atomoxetine -- Risk of suicidal thoughts......................................................................... 1 Bacitracin, Fusafungine, Gramicidin, Tyrothricin -- Locally administered products withdrawn ...... 2 Cetuximab -- Recommendations for electrolyte monitoring..................................................... 2 Duloxetine -- Reports of adverse hepatic effects ................................................................ 2 Fentanyl transdermal system -- Labels updated for safe and appropriate use............................ 2 Hexavac -- Suspended due to concerns about long-term effects against hepatitis B.......................... 3 Medroxyprogesterone -- Loss of bone marrow density ....................................................... 3 Meloxicam -- Juvenile rheumatoid arthritis indication: label updated .......................................... 3 Nabumetone -- Stronger labelling for renal effects.............................................................. 4 Non-selective NSAIDs -- No changes to current prescribing practice........................................ 4 Paroxetine -- Potential risk in pregnancy .......................................................................... 4 Thioridazine -- Sale discontinued in Canada ..................................................................... 5 Safety of Medicines Anti-TNF alpha products -- New measures to prevent activation of latent tuberculosis ................... 6 Beta-2 agonists -- Increased risks of asthma-related deaths................................................... 6 Cabergoline -- Use linked to gambling............................................................................ 6 Codeine & hydrocodeine -- Akathisia with long-term use .................................................... 6 Ezetimibe -- Reports of muscle pain............................................................................... 7 Hydromorphone -- Co-ingestion with alcohol harmful.......................................................... 7 Ibuprofen -- Reports of Stevens-Johnson syndrome............................................................. 7 Isotretinoin -- Strengthened risk management programme .................................................... 8 Trastuzumab -- Addition to chemotherapy increases toxicity .................................................. 8 Vinca alkaloids -- Intrathecal administration reported........................................................... 8 Feature Twenty-eighth Annual Meeting of Representatives of the National Centres participating in the WHO Programme for International Drug Monitoring: Observations from Working Group Exercises...........10 REGULATORY MATTERS recommended doses of the advise patients of the risks agent. See WHO associated with atomoxetine Amfetamine Pharmaceuticals Newsletter (Strattera) and precautions that Reintroduced with No. 2, 2005). can be taken, should be revised prescribing and distributed to patients when patient information Reference: atomoxetine (Strattera) is Dear Health-care Professional' dispensed. The increased risk of Canada. Health Canada is letter from Shire Biochem Inc., suicidal thinking in children was allowing Shire BioChem Inc.'s 31 August 2005 identified in a combined mixed-salts amfetamine (http://www.hc-sc.gc.ca). analysis of 12 short-term (6-18 preparation containing neutral weeks) placebo-controlled trials sulfate salts of dextro- (11 in ADHD and 1 in enuresis). amfetamine and amfetamine Atomoxetine The analysis showed a greater (Adderall XR) back on the Risk of suicidal risk of suicidal thinking during Canadian market following a thoughts the first few months of recommendation from the treatment in those receiving independent New Drug UK, USA. Atomoxetine atomoxetine (Strattera) Committee, who reviewed the (Strattera), is a drug approved compared to placebo-treated suspension of the sale of the for the treatment of Attention patients. The FDA has drug. Health Canada says that, Deficit Hyperactivity (ADHD) in recommended the following for in accordance with the paediatric and adult patients. inclusion in the boxed warning: Committee's recommendations, The UK Medicines and it will allow the product Healthcare products Regulatory • Atomoxetine (Strattera) (Adderall XR) to be Agency (MHRA) has issued a increases the risk of suicidal reintroduced after steps have Press Release with updated thinking in children and been taken, including the warnings on the risk of suicidal adolescents with ADHD. revision of the product's thoughts with atomoxetine prescribing and patient (Strattera). According to the • Anyone considering the use information to reinforce the Press Release Lilly, the of atomoxetine (Strattera) in safe use of the drug and to manufacturer of atomoxetine a child or adolescent for highlight the safety concerns (Strattera) in the UK, has ADHD must balance the associated with its use submitted data that do identify increased risk of suicidal (including the risk of sudden an increased risk of suicidal thinking with the clinical cardiac death in paediatrics). thoughts in children receiving need for the drug. Shire BioChem Inc. has been the drug. The MHRA is planning recommended to issue a `Dear to look into the health risks and • Patients who are
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