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pharmaceuticals newsletter
WHO Pharmaceuticals Newsletter 1998, No. 09&10
(1998; 23 pages)
Table of Contents
Regulatory decisions
Albumin (human) B batches withdrawn: increase in aluminium level: Austria
Astemizole - warning concerning arrhythmias: Brazil
Chlormezanone - withdrawn: Zimbabwe
Chlorzoxazone - warning: hepatotoxicity: Chile
Cidofovir - adverse reactions: nephrotoxicity, uveitis/iritis and hearing loss: Gilead Sciences, USA
Fenfluramine and dexfenfluramine - temporary suspension: Brazil
Fenfluramine and dexfenfluramine - warning concerning adverse reactions: Chile
Ionic contrast media - notice of withdrawal: Germany
Laxatives containing aloe, bisacodyl, cascara sagrada and senna - proposed reclassification: USA
Meloxicam - data sheet revised: gastrointestinal and skin reactions: UK
Metamizole sodium - withdrawn due to agranulocytosis: Zimbabwe
Mibefradil - suspended: Germany
Nifedipine - re-approved in myocardial infarction: New Zealand
Psorial ointment - sales prohibited: undeclared cortisone ingredients: Sweden
Psorigon cream & lotion - withdrawn: undeclared cortisone ingredients: Germany, USA
Ticlopidine - revised data sheet: thrombotic thrombocytopenic purpura: Roche, USA
Troglitazone - revised instructions for use: Parke-Davis, USA
Vitamin A and betacarotene - labelling claim prohibited: USA
Drug surveillance
Albumin and plasma protein fraction - safety concerns: USA
Alendronic acid - reminder: oesophageal reactions: UK
Drug-induced amnesia - review: Australia
Isotretinoin - depression: Australia
Isotretinoin - adverse reaction profile: UK
Leukotriene antagonists: montelukast & zafirlukast - safe use: UK
Levonorgestrel - use for emergency contraception: WHO/HRP
Selective serotonin reuptake inhibitors (SSRIs) - haemorrhage: Australia
Sildenafil (Viagra) - summary of reports of death: update: USA
Tryptophan, 5HTP and eosinophilia-myalgia syndrome - impurities confirmed: USA
New developments
Fomepizole - approved as an antidote in ethylene glycol poisoning: USA
Infliximab - approved for Crohn’s disease: USA
Leflunomide - oral treatment approved for active rheumatoid arthritis: USA
Lepirudin - approved for heparin-associated thrombocytopenia: UK
Oral contraceptives - approved for emergency use: USA
Rotavirus vaccine - approved to help prevent rotaviral disease: USA
Thalidomide - approved for use in leprosy: USA
New indications
New formulations
Newly approved products
Medical devices
Blood glucose meters - recalled because of error readings: USA
EpiPen epinephrine auto-injectors - recall of syringes: Switzerland
Medical devices - the year 2000 problem: guidance document: USA
Skin wound closure adhesive - approved: USA
Weight loss device - recalled: USA
General information
Biotechnological/biological products - draft guidance available: USA
Blood and blood components - draft guidance available: USA
Nucleic acid sequence - in vitro tests - draft guidance available: USA
Paediatric exclusivity - draft guidance available: USA
Self-medication - medicines now available without prescription: Germany, France
Topical dermatological drug products - draft guidance available: USA
Vaccines and related products - draft guidance available: USA
Medication errors
Flomax and Fosamax - name confusion: USA
Invirase and Fortovase (saquinavir) - confusion between two formulations: USA
Lipid-based drug products - errors due to confusion with conventional products: USA
Minimizing medical product errors - summary of workshop available: USA
Neumega and Neupogen - name confusion: USA
Nortriptyline - errors in dosage: USA
Oxycodone - errors due to formulation confusion: USA
Soriatane and Loxitane - prescribing errors due to name confusion: USA
Veterinary medicine
Clenbuterol-containing veterinary medicines - suspension of indication extended: Germany
Ipronidazole in veterinary medicines - marketing authorization revoked: carcinogenicity: Germany
Labelling of drugs for use in milk- producing animals - revised regulations: final rule: USA
WHO Pharmaceuticals Newsletter 1998, No. 09&10
Essential Drugs and Medicines Policy
WHO.INT
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