WHO DRUG INFORMATION VOLUME 7 • NUMBER 4 • 1993 PROPOSED INN LIST 70 INTERNATIONAL NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES WORLD HEALTH ORGANIZATION • GENEVA WHO DRUG INFORMATION WHO Drug Information provides an overview of topics relating to drug development and regulation that are of current relevance and importance, and includes the lists of proposed and recommended International Nonproprietary Names for Pharmaceutical Substances (INN). Its contents reflect, but do not present, WHO policies and activities and they embrace socioeconomic as well as technical matters. The objective is to bring issues that are of primary concern to drug regulators and pharmaceutical manufacturers to the attention of a wide audience of health professionals and policy-makers concerned with the rational use of drugs. In effect, the journal seeks to relate regulatory activity to therapeutic practice. It also aims to provide an open forum for debate. Invited contributions will portray a variety of viewpoints on matters of general policy with the aim of stimulating discussion not only in these columns but wherever relevant decisions on this subject have to be taken. WHO Drug Information is published 4 times a year and can be ordered from: Distribution and Sales, World Health Organization, 1211 Geneva 27, Switzerland. Annual subscription: Sw. fr. 60.— Airmail rate: Sw.fr. 72.— Price per copy: Sw.fr. 20.— © World Health Organization 1993 Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention. For rights of reproduction or translation, in part or in toto, application should be made to: Chief, Office of Publications, World Health Organization, 1211 Geneva 27, Switzerland. The World Health Organization welcomes such applications. 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 Secretariat 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. Authors alone are responsible for views expressed in signed contributions. The mention of specific companies or of certain manufacturer's products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature which are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. ISSN 1010-9609 World Health Organization, Geneva WHO Drug Information Volume 7, 1993: Index A E ACE inhibitors & digoxin, (4) 169 Essential drugs, (4) 190 Acetylsalicylic acid, (4) 185 Estrogens, topical, (4) 175 Aconite alkaloids, (2) 51 Advertising, European Community, (1) 29 F journals, (3) 115 Aerosol drug delivery, (4) 180 Fees, USA, (4) 189 AIDS update, (4) 163 Folic acid and spina bifida, (3) 106 Ampicillin, (1) 38, (4) 172 Food supplements, (1) 25 Antiarrhythmic agents, (3) 116 Antidepressants and suicide, (1) 18 G Antihyperlipidaemic agents, (3) 123 Gamma-hydroxybutyric acid, (1) 25 Antimicrobial susceptibility testing, Gene therapy, (4) 161 guidelines, (2) 68 Glucocorticoids, inhaled, (4) 170 Antimicrobials, streptococci, (2) 60 Group B streptococcal disease, (2) 64 Antiretroviral drugs, recommendations, (3) 124 Gums, water-soluble, (4) 187 Applications, computerized, (1) 29 Artemisinin, malaria, (3) 111 H Artesunate/mefloquine, (1) 7 Haemophilus influenzae vaccine, (1) 9 Atovaquone, Pneumocystis pneumonia, (3) 123 Halofantrine, data sheet, (2) 67 malaria, (2) 49 B Helicobacter pylori, multidrug therapy, (2) 57 Beclometasone dipropionate, (4) 171 Hepatitis A, vaccine, (3) 132 Benzodiazepines, (1) 23 Hepatitis B immune globulin, (3) 131 Beta-blockers, depression, (1) 14 vaccine, (3) 130 Biotechnology, (1) 29 Hepatitis, viral, (3) 128 products, ADRs, (2) 64 HIV, vaccines, (4) 163 Bismuth subsalicylate, (3) 127 drug-induced cutaneous reactions, (2) 54 Blood products, (4) 185 Hospital-acquired infections, susceptibility, (2) 70 Bovine brain gangliosides, (3) 124 Human immunoglobulin, (3) 132 Budesonide, (4) 171 Hypnotics, short-acting, (3) 125 C I Cefalosporins, sickle-cell disease, (3) 121 ICDRA, (3) 97 Ciprofloxacin, (1) 40 Identification codes, tablets and capsules, (3) 126 Clavulanic acid, jaundice, (1) 33 Immune globulins, nosocomial infections, (1) 16 Cold chain, vaccines, (4) 183 Immunoglobulin, human, (3) 132 Compliance, (4) 181 Guillain-Barré syndrome, (3) 110 Computerized new drug applications, (1) 29 Influenza vaccine, (4) 178 Corticosteroids, asthma, (1) 18 Infrared chemical reference spectra, (1) 27 Coumarins, filarial lymphoedema, (4) 177 Interferon beta-1b, multiple sclerosis, (4) 187 International conference of drug regulatory D authorities, (3) 97 Dapsone-pyrimethamine, (3) 101 International guidelines for biomedical Didanosine, (4) 165 research, (1) 42 Diethylstilbestrol, (3) 103 International infrared chemical reference Digoxin and ACE inhibitors, (4) 169 spectra, (1) 27 Drug labelling, (2) 43 Iron deficiency, (1) 4 Drug regulation, developing countries (1) 1 Isoniazid, tuberculosis, (3) 113 Dysentery, (1) 36 Ivermectin, (1) 6 1 WHO Drug Information Volume 7, Index 1993 K,L S Ketorolac, (2) 64 Second malignancies, (4) 182 Labelling, (2) 43 Slimming regimens, herbal, (2) 52 M Sotalol, (2) 65 Sponsored symposia, (1) 26 Malaria vaccination, (2) 45 Sponsorship, (1) 31 halofantrine, (2) 49 Stavudine, (2) 65 Mefloquine/artesunate (1) 7 Streptococci, antimicrobials, (2) 60 Metronidazole, (1) 41 Sulfamethoxazole/trimethoprim, (1) 38 Misoprostol, (3) 126 Sulfasalazine, (2) 66 Model list of essential drugs, (4) 190 Sumatriptan, (2) 66 Mucosal immunity, vaccine, (2) 55 Symposia, sponsored, (1) 26 Multidose vials, (1) 24 Multidrug-resistant tuberculosis, (1) 21 T Multidrug therapy, Helicobacter pylori, (2) 57 Multiple sclerosis, interferon beta-1b, (4) 187 Tablet identification codes, (3) 126 Tacrine, (3) 104, (3) 127 N Thioacetazone, (1) 21 Transmissible pathogens in biologicals, (3) 118 Nalidixic acid, (1) 39 Tretinoin, topical, (4) 188 Neonatal streptoccal infections, (4) 172 Trimethoprim/sulfamethoxazole, cutaneous Nonsteroidal anti-inflammatories, (1) 33 reactions, (2) 54 Nucleoside therapy, AIDS, (4) 164 Tryptophan, (1) 25 O Oral rehydration salts, (1) 37 U Orphan drugs, (1) 29 UN consolidated list of products whose ORS, (1) 37 consumption and/or sale have been banned, withdrawn, severely restricted or not approved P by governments, (1) 1 Paclitaxel, (1) 35 Paroxetine, (2) 64 V Pathogens in biologicals, (3) 118 Vaccine, Haemophilus influenzae, (1) 9 Patient compliance, (4) 181 hepatitis A, (3) 132 rights, (3) 99 hepatitis B, (3) 130 Pertussis vaccine, (1) 11 influenza, (4) 178 Pharmacists in Europe, (2) 79 malaria, (2) 45 Pneumococcal vaccines, (1) 12 mucosal immunity, (2) 55 Poliovirus vaccines, (3) 108 pertussis, (1) 11 Propofol, (3) 127 pneumococcal, (1) 12 Propylene glycol, control, (3) 127 poliovirus, (3) 108 Psychotropics, pregnancy, (1) 23 Vaccines, cold chain, (4) 183 Pyrimethamine-dapsone, (3) 101 HIV, (4) 163 Vials, multidose, (1) 24 Q Vitamin A, deficiency, (1) 5 Quality assurance, blood products, (4) 185 control in developing countries, (3) 134 W Quinolone antibiotics, (2) 65 Water-soluble gums, (4) 187 Women in trials, (4) 189 R Regulation of drugs, (1) 1 Z Research, international guidelines for Zalcitabine, (4) 166 biomedical, (1) 42 Zidovudine, (2) 47, (4) 165 Rifampicin, (1) 21 2 Volume 7, Number 4, 1993 World Health Organization, Geneva WHO Drug Information Contents General Policy Topics Regulatory Matters Gene therapy: the regulatory challenge 161 Acetylsalicylic acid and the heart 185 Blood products and quality assurance 185 Update on AIDS Water-soluble gums: dangers of oesophageal obstruction and asphyxiation 187 The current situation 163 Vaccine development 163 Interferon beta-1b for multiple sclerosis 187 Nucleoside therapy 164 Topical tretinoin and birth defects 188 US FDA to levy fees on pharmaceutical companies 189 Reports on Individual Drugs Women in drug trials: change in US policy 189 Digoxin and heart failure: does it increment the response to ACE inhibitors 169 Essential Drugs Inhaled glucocorticoids: safety in children 170 WHO Model List: revised in November 1993 190 Neonatal streptococcal infections: hope for a preventive strategy 172 Topical estrogens and recurrent post­ Proposed International menopausal urinary tract infections 175 Nonproprietary Names: List 70 203 Coumarins: symptomatic relief of filarial lymphoedema 177 Influenza vaccine: further reassurance regarding adverse effects 178 General Information Assessing the efficiency and reliability of aerosol drug delivery systems 180 Patients who don't take their medicines 181 Second malignancies after treatment of childhood cancers 182 Vaccines: managing the cold chain 183 i WHO Drug Information Vol. 7, No. 4, 1993 General Policy Topics Gene therapy: proposals concerning gene therapy and somatic- cell therapy have been submitted to the United the regulatory challenge States Food and Drug Administration, which retains responsibility for assessing the quality, safety and Over the past decade a remarkable insight has efficacy of products under development (2). The been gained into physiological processes as they range of applications to which such products are operate at cellular level. This has emerged from a already directed is highly diverse. As well