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pharmaceuticals newsletter
WHO Pharmaceuticals Newsletter 1998, No. 11&12
(1998; 10 pages)
Table of Contents
Regulatory actions
Acetylsalicylic acid and paracetamol: stricter controls: UK
Alcohol warning: revised labelling of all OTC pain relievers & fever reducers: USA
Camphor and/or menthol: warning concerning fire hazard: USA
Cholestin: determined to be an unapproved drug: USA
Corticosteroids (inhaled and intranasal formulations): new labelling required for use in children: USA
Ephedrine and atropine: not accepted in final monographs for OTC internal analgesic or menstrual use: USA
Eritrityl tetranitrate: withdrawal of approval: lack of efficacy: USA
L-desoxyephedrine (levmetamfetamine): added to monograph for OTC nasal decongestant drug products: USA
Magnesium sulfate: revised labelling: UK
Nucleoside analogues: revised product information: hepatic steatosis and lactic acidosis: Portugal
Povidone-iodine: warning concerning overdosage: Austria
Soy protein and coronary heart disease: new health claim proposed: USA
Tick-borne encephalitis virus vaccine: paediatric formulation withdrawn: adverse reactions: Germany
Drug surveillance
Cannabis: research into medical uses approved: UK
Carboplatin: hearing loss associated with treatment avoidable: USA
Excipients: review of adverse reactions: France
Immunoglobulin intravenous (human): review: acute renal failure: USA
Nicotinic acid: visual loss: UK, USA
Propacetamol: contact eczema: France
New developments
Carvedilol: approved for use in chronic heart failure: UK
Efavirenz: approved for use in HIV infection and AIDS: USA
Essential fatty acids and coal tar (Exorex): approved for treatment of psoriasis: UK
Etanercept: first biotechnology product approved for arthritis: USA
Fentanyl citrate lozenges: approved for breakthrough cancer pain: USA
Rizatriptan: approved for treatment of migraine: UK
Tamoxifen: approved for reduction of breast cancer incidence: USA
Trastuzumab: new monoclonal antibody approved for advanced breast cancer: USA
New indications
Newly approved products
Medical devices
Coronary stent delivery system: recalled: risk of patient injury due to balloon leakage: USA
Electrode lead wires: guidance on performance standard available: USA
General information
Allergen extract or allergen patch test: draft guidance available: USA
Antimicrobial drug products: draft guidances available: USA
Drugs for Dementia: guide available: UK
Non-contraceptive estrogens labelling: draft guidance available: USA
Out of specification test results: draft guidance available: USA
Vaginal yeast infections (vulvovaginal candidiasis): draft guidance available on labelling of OTC products: USA
Medication errors
Eptifibatide (Integrilin): potential for errors: USA
Narcon and Norcuron: name confusion: USA
Veterinary medicine
Bacitracin methylene disalicylate and nitarsone: approved for prevention of blackhead: USA
Bacitracin methylene disalicylate and zoalene: approved for prevention and control of coccidiosis: USA
Bambermycins: approved in cattle: USA
Formalin solution: approved for as a parasiticide and fungicide in fish: USA
WHO Pharmaceuticals Newsletter 1998, No. 11&12
Essential Drugs and Medicines Policy
WHO.INT
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