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WHO Drug Information Vol WHO Drug Information Vol. 16, No. 1, 2002 World Health Organization WHO Drug Information Contents Vaccines and Biomedicines Hua Fo: unknown substance 26 Sibutramine safety review 26 International reference materials for Cyproterone with ethinylestradiol: risk of Creutzfeldt-Jakob disease 3 venous thromboembolism 27 WHO position on rabies vaccine 4 Alfa interferons: labelling change 27 Nefazodone: rare cases of liver failure 28 Safety Information Acarbose, zafirlukast and vincristine: WHO international drug monitoring: revised precautions 28 cerivastatin and gemfibrozil 8 Clozapine and myocarditis 28 International Conference on Harmonization Methotrexate: interactions 29 (ICH): pharmacovigilance activities 11 Stavudine: neuromuscular weakness 29 The COX-2 inhibitors 12 Recommended influenza virus vaccine Amiodarone and pulmonary toxicity 14 composition 29 Alendronate: link with pancreatitis? 14 Sodium phosphate oral solution: electrolyte Endocrinotoxicity induced by Coriandrum balance disturbance 30 sativa: a case report 15 Haemolysis after consumption of Viola tricolor 15 Lipodystrophy syndrome under-reported 16 Quality Assurance Issues WHO pilot pre-qualification project for pharmaceutical products: evaluation Current Topics of product files 31 Progress in pharmacogenetics and Access to HIV drugs and diagnostics 31 pharmacogenomics 17 List of pre-qualified products — 20 March 2002 32 Internet sales and reimbursement by insurance companies 20 Nevirapine: comments on HIVNET 012 from Recent Publications and Sources the manufacturer 21 Review of HIVNET 012 21 of Information Mother-to-child transmission of HIV: WHO WHO guidelines on stability testing 35 statement 22 WHO Model Formulary now available 35 Direct to consumer advertising 36 The information gap: new resource for Regulatory and Safety Action developing countries 36 Enoxaparin sodium injection: new safety warnings 23 Proposed International Ziprasidone hydrochloride: labelling 37 clarifications 23 Nonproprietary Names: List 86 Kava kava products and potential liver injury 24 Kava kava: investigations into liver injury 24 Rofecoxib interaction with warfarin 25 Recommended International Zolpidem and neurological reactions 25 81 Paroxetine: withdrawal symptoms 26 Nonproprietary Names: List 47 1 WHO Drug Information Vol. 16, No. 1, 2002 WHO Drug Information is now available at: http://www.who.int/druginformation 2 WHO Drug Information Vol. 16, No. 1, 2002 Vaccines and Biomedicines International reference materials Variant Creutzfeldt-Jakob Disease The number of human subjects incubating vCJD for Creutzfeldt-Jakob disease remains unknown and concern about the potential infectivity of their blood is affecting public health Transmissible spongiform encephalopathies (TSEs) policy on supply of blood products in several coun- include bovine spongiform encephalopathy (BSE) in tries. As is the case for CJD, there has been no cattle, scrapie in sheep, and Creutzfeldt-Jakob evidence of transmission of vCJD by blood or blood disease (CJD) in humans. TSEs are characterized components or plasma-derived products. vCJD is by spongiform degeneration of the brain and the however a new emerging disease and the risk is transformation of the normal form of a ubiquitous unknown. protein termed prion protein, PrPc, into an abnormal sc sc isoform, PrP . PrP is the only marker of the Although novel antibodies and new applications of disease. existing technologies have been developed as Concern has been generated following the appear- promising approaches for diagnostic procedures for ance of a variant Creutzfeldt-Jakob (vCJD) disease vCJD, they are at a relatively early stage of devel- in the United Kingdom linked to bovine spongiform opment. Pre-mortem clinical diagnosis of vCJD by encephalopathy (BSE) and action has been taken magnetic resonance imaging (MRI) seems to be to reduce channels of transmission. Cases of vCJD reliable. However, diagnosis during the asympto- have now reached 130 internationally — raising the matic incubation period is not yet possible and a profile of this class of disease as a risk to human reliable diagnostic method based on easily accessi- health. ble samples, such as serum, is indispensable. There is also a need for independent comparison of Sporadic, familial and iatrogenic the various laboratory approaches to diagnosis. Creutzfeldt-Jakob disease The accurate diagnosis of CJD is currently based WHO International Reference Materials on postmortem histopathological examination of the The availability of reliable diagnostic procedures brain or immunohistopathology, which adds an would allow the detection of asymptomatic subjects extra level of certainty when appropriate antibodies during the long periods of incubation of CJD and and techniques are used. Pre-mortem diagnosis vCJD. Panels of reference materials of various remains problematic and is limited to detection kinds need to be built up to compare the effective- through clinical features or electroencephalo- ness of new in vitro and in vivo assay systems sc graphic (EEG) findings. No validated preclinical using animal models and relate detection of PrP diagnostic tests are currently available for the and infectivity. Comparability of levels of detection detection of PrPsc. of TSE agents by different methods will only be possible through the availability of these prepara- Bovine spongiform encephalopathy tions. Decisions concerning the safety of pharma- Methods for the accurate diagnosis of pre-or post- ceuticals and blood products can then be taken mortem BSE which may be applied on a large scale based on scientific findings and would considerably to the examination of animals either at or prior to strengthen precautionary measures implemented slaughter, would have major epidemiological impli- by medicines regulatory authorities. cations in minimising the risk of infection to other animals or to humans through food or biological The need to develop a panel of international refer- materials used in the production of medicinal prod- ence materials for the diagnosis and study of ucts. ELISA and Western Blot testing of brain transmissible spongiform encephalopathies (TSEs) tissues can already be used to detect some pre- for validation of CJD and vCJD diagnostic proce- clinical cases postmortem. No ante-mortem diag- dures and for the comparison of methods was first nostic methods suitable for testing live asympto- discussed during a WHO Consultation held in 1999. matic animals during the incubation period of BSE A WHO Working Group on International Reference are available. Materials for Diagnosis and Study of TSEs was 3 Vaccines and Biomedicines WHO Drug Information Vol. 16, No. 1, 2002 established to identify needs and priorities for the will benefit public health internationally, and WHO production of international reference materials and will offer these materials as calibrants to laborato- development of a WHO repository. The develop- ries seeking to optimize a variety of in vitro and in ment of human brain-derived materials as candi- vivo diagnostic procedures for TSEs. date biological reference materials to compare the sensitivity of assays for CJD and vCJD is now Development of brain derived materials from cattle under way. Four human brain-derived with bovine spongiform encephalopathy (BSE) and homogenates have been prepared from: from sheep with both BSE and scrapie infections will also be addressed in collaboration with the • uninfected brain; Organisation International des Epizooties (OIE). • sporadic CJD brain type 1 (sp1CJD); References • sporadic CJD brain type 2 (sp2CJD); and • variant CJD brain (vCJD). 1. Information on the WHO Working Group on Interna- tional Reference Materials for Diagnosis and Study of Thirteen international laboratories will characterize TSEs: http://www.who.int/biologicals these materials and work on in vitro assays of PrPsc content. The brain samples which have been 2. World Health Organization. Report of a WHO Consulta- provided for analysis cover all PrPsc types de- tion on Medicinal and other Products in Relation to Human scribed. These samples have also been distributed and Animal Transmissible Spongiform Encephalopathies. to twelve laboratories to perform Western immuno- Geneva, Switzerland, 24–26 March 1997. blot tests according to agreed protocols. Informa- 3. World Health Organization. Report on a WHO Consul- tion from these activities will be fundamental in tation on Diagnostic Procedures for Transmissible Spongi- confirming their suitability for development as form Encephalopathies (TSEs): Need for Reference International Reference Materials. A WHO directed Reagents and Reference Panels. Geneva, Switzerland, study of the Terminology of Human PrPsc types and 22–23 March 1999. subtypes is also being carried out to resolve the current disparity in the literature on the existence of 4. World Health Organization. Report on a Working Group distinct human PrPsc types associated with sporadic on International Reference Materials for Diagnosis and or acquired CJD. Study of Transmissible Spongiform Encephalopathies (TSEs). Geneva, Switzerland, 21–22 September 1999. Results from the in vitro studies were analysed at a 5. World Health Organization. Report on International meeting of the WHO Working Group on Interna- Reference Materials for Diagnosis and Study of Transmis- tional Reference Materials for Diagnosis and Study sible Spongiform Encephalopathies (TSEs). Geneva, of TSEs in April 2002. Results from laboratories Switzerland, 25–26 May 2000. using different modifications
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