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WHO Drug Information Vol. 20, No. 4, 2006 WHO DRUG INFORMATION VOLUME 20• NUMBER 4 • 2006 PROPOSED INN LIST 9 6 INTERNATIONAL NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES WORLD HEALTH ORGANIZATION • GENEVA WHO Drug Information Vol 20, No. 4, 2006 World Health Organization WHO Drug Information Contents Medicines for Tuberculosis ICH efforts to improve processes 267 Emergence of extensively-resistant Anticounterfeiting Taskforce develops tuberculosis 239 strategy 268 Development of new drugs for tuberculosis 240 Regulatory Action and News Bevacizumab approved for lung cancer 271 Safety and Efficacy Issues Risperidone for irritability associated Teratogenicity of antiepileptic drugs 246 with autism 271 Meningococcal vaccine and Guillain New treatment for chronic hepatitis B 271 Barré syndrome 247 Influenza virus vaccine composition: Panama mystery illness traced to 2007 southern hemisphere 272 diethylene glycol 248 Sitagliptin phosphate for diabetes 272 Imatinib and cardiac dysfunction 248 Dronedarone: marketing application Online reporting of adverse reactions 249 withdrawn 273 SSRI-tricyclic antidepressant interaction 249 Repaglidine marketing authorization Telithromycin: hepatic events and extension request withdrawn 273 myasthenia gravis 250 Abetimus marketing authorization Bioglue®: chronic inflammation 250 request withdrawn 273 Beware the triple wammy! 251 Imatinab mesilate: revised indications 273 Colchicine: safe use is critical 252 Nitrofurantoin: monitor lung function Recent Publications, in long-term use 252 Proton pump inhibitors and interstitial Information and Events nephritis 253 Vigiflow Online for pharmacovigilance 275 Package insert changes 253 Scientific plant names and synonyms 275 Leflunomide and peripheral neuropathy 256 Pharmaceutical inventory control Exetimibe and depression? 256 software 276 Sirolimus: acute rejection in renal Reporting adverse reactions and transplant patients 257 continuing education 276 Safety update for oseltamivir 257 Good governance in medicines Darifenacin hydrobromide for overactive procurement 276 bladder: what advantage? 258 WHO public hearings on innovation and Tigecycline for serious infections 259 intellectual property 277 Pharmaceutical Forum: better informa- tion, access and prices 278 Rational Use of Medicines Pharmacy education symposium: multi- The role of prescribed and defined daily disciplinary practice 278 doses in pharmacoepidemiology 261 Pharmaceutical policy analysis Asthma/COPD drugs: PDDs are critical conference in 2007 279 to determining DDDs 261 Final guidance on quality systems 279 Newly-available guidance documents 280 Topics of Current Interest Development of medicines for neonates 265 Proposed International Plan for paediatric essential medicines 265 Nonproprietary Names: 200 African scientists join forces 266 New strategy to fight tropical diseases 267 List 96 281 237 World Health Organization WHO Drug Information Vol 20, No. 4, 2006 Announcement The 13th International Conference of Drug Regulatory Authorities (ICDRA) will be hosted by the Swiss Medicines Agency SWISSMEDIC in collaboration with the World Health Organization. The ICDRA will take place in Berne, Switzerland from 16 to 19 September 2008. Updated information will be provided regularly at: http://www.icdra.ch or http://www.who.int/medicines/icdra/en/index/html 238 WHO Drug Information Vol 20, No. 4, 2006 Medicines for Tuberculosis Emergence of extensively drug-resistant tuberculosis Tuberculosis (TB) is generally treated with a course of four first-line drugs. How- ever, if misused or mismanaged, resistance can develop and multidrug-resistant TB has emerged as a serious threat to the success of treatment programmes. Multidrug-resistant TB requires the use of second-line drugs that are less effec- tive, more toxic, and costlier than the first-line isoniazid- and rifampicin-based regi- mens. With 425 000 new cases of drug resistant TB globally each year, resistance to drugs is a problem that is growing at a rapid pace. Earlier this year, a WHO/US Centers for Disease Control prevention study was published documenting for the first time cases of tuberculosis that are extensively resistant to current drug treatments. Extensively drug-resistant (XDR)TB was iden- tified in all regions of the world. Results of the survey showed that during the period 2000—2004, 20% of TB isolates were multidrug-resistant and 2% were extensively drug-resistant (XDR). XDR TB could cause a future epidemic of virtually untreatable TB. Concerns about the emergence of XDR-TB have been heightened by reports and studies of high mortality rates in HIV-positive people with XDR-TB. This has led to warnings that XDR-TB could seriously threaten the progress being made in countries on TB control and the scaling up of universal access to HIV treatment and prevention. New anti-TB drug regimens and better diagnostic tests are urgently needed for effective detection and treatment of drug-resistant TB. Using standard drugs to treat XDR-TB without knowing whether there is drug resistance could effectively condemn a patient to death. The emergence of XDR TB, coupled with increased use of second-line drugs, suggests that urgent measures are needed to establish population-based surveillance for resistance and to plan public health responses. WHO Global Task Force of XDR-TB will not be possible without on XDR-TB launched close coordination between all those At its first meeting in October 2006, a concerned and, in particular, with HIV WHO Global Task Force outlined a series programmes. The Task Force also of measures that countries must imple- provided recommendations on: ment to effectively combat XDR-TB. The Task Force has acted to establish teams • Drug-resistant TB surveillance methods that can respond to requests for technical and laboratory capacity measures. assistance and be deployed at short notice to risk areas worldwide. • Implementing infection control meas- ures to protect patients, health care Along with a call for countries to strength- workers and visitors (particularly those en TB control, it was agreed that control who are HIV infected). 239 Medicines for Tuberculosis WHO Drug Information Vol 20, No. 4, 2006 • Access to second-line anti-TB and 6. Accelerate and widen implementation antiretroviral drugs for countries; com- of recommended infection control meas- munication and information-sharing ures in health care settings and other risk strategies related to XDR-TB preven- areas in order to reduce the ongoing tion, control, and treatment including co- transmission of drug-resistant TB, espe- management with antiretroviral therapy. cially among those who are HIV positive. • Research and development of new TB The laboratory definition of XDR-TB was drugs, vaccines and diagnostic tests. confirmed as: resistance to at least rifampicin and isoniazid from among the • Management of XDR-TB suspects in first line anti-TB drugs in addition to high and low HIV prevalence settings. resistance to any fluoroquinolone, and to at least one of three injectable second- • Accelerating access to rapid tests for line anti-TB drugs used in TB treatment rifampicin resistance, to improve case (capreomycin, kanamycin, and amikacin). detection of all patients suspected of multidrug-resistant TB (MDR-TB) so Future meetings are also planned on that they can be given treatment that is XDR-TB, including development of as effective as possible. Rapid diagno- urgently needed new diagnostics, drugs sis is potentially life saving to those who and vaccines, and implications of antiret- are HIV positive. roviral therapy for HIV patients. Task Force members contine to coordi- References nate with national and international 1. World Health Organization. Press Release. partners involved in TB and HIV preven- 17 October 2006 http://www.who.int/ tion, care and treatment to take the mediacentre/news/notes/2006/np29 recommendations forward. They have 2. Addressing the threat of tuberculosis. also developed a plan to identify re- Weekly Epidemiological Record, 2006;81:386 sources required to implement outcomes and accelerate the overall emergency 3. Emergence of Mycobacterium tuberculosis response. The Task Force also recom- with extensive resistance to second-line mends that national TB Programme drugs. Mortality and Morbidity Weekly Report, priorities should focus on: 2006, 55(11);301–305 1. Adherance to WHO Guidelines for Programmatic Management of Drug Development of new drugs Resistant TB. for tuberculosis 2. Improve MDR-TB management condi- An analysis of the current drug pipeline tions. for tuberculosis drugs has been published in a recent report by Médecins sans 3. Enable access to all MDR-TB second- Frontières (MSF)* in support of its Cam- line drugs, under proper conditions. paign for Access to Essential Medicines. The analysis shows that greater invest- 4. Ensure all patients with HIV are ad- ment is required to respond to extensively equately treated for TB and started on drug-resistant (XDR) TB emergence and appropriate antiretroviral therapy. * The complete report “Development of new 5. Infection control and protection of drugs for TB chemotherapy” is available at http:/ health care workers with emphasis on /www.accessmed-msf.org/documents/ high HIV prevalence settings. TBPipeline.pdf 240 WHO Drug Information Vol 20, No. 4, 2006 Medicines for Tuberculosis newer drugs will need to be available to trant nature of persistent infections pose patients as soon as possible, with accel- additional challenges to treatment with erated development of those already in currently available anti-TB
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