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pharmaceuticals newsletter
WHO Pharmaceuticals Newsletter 1998, No. 03&04
(1998; 18 pages)
Table of Contents
Regulatory actions
Aluminium in total parenteral nutrition - labelling requirements & warning
Astemizole - warning concerning cardiovascular adverse events
Bromfenac - warning label: liver damage
Carbamazepine - warning concerning precipitation
Chlormezanone - withdrawn
Counterfeit drugs - warning to the public
Dietary supplement "Sleeping Buddha" - warning concerning estazolam content
Fenfluramine - withdrawn
Human dura mater (freeze-dried) - restrictive measures
Isotretinoin - psychiatric adverse effects
Pyrithione zinc (Skin-CapR) - withdrawn
Sertindole - approval application withdrawn
Terfenadine - additional drug interactions
Terfenadine - withdrawn following approval of fexofenadine
Drug surveillance
Acetylsalicylic acid and NSAIDs - OTC availability: increased potential for adverse reactions
Drug-induced depression - review
Midazolam - paradoxical reactions in children
Selective serotonin reuptake inhibitors (SSRIs) - neonatal disorders
Sumatriptan - fatal outcomes
Venlafaxine - review of adverse reactions
New developments
Finasteride - approved for male pattern baldness
Paracetamol/acetylsalicylic acid/caffeine - first OTC medicine approved for migraine
Quetiapine - a new treatment for schizophrenia approved
Recent approvals
Medical devices
Chlorhexidine-impregnated medical devices - hypersensitivity reactions
Positron Emission Tomographic (PET) products - exemptions to CGMP: final rule revoked
General information
Advertising of medicinal drugs in the media - regulations
Container and closure testing in lieu of sterility testing - draft guidance available
Extended release oral dosage forms - draft guidance available
Human plasma-derived biological products or animal plasma or serum-derived products - draft guidance available
Iron-containing supplements and drugs - small entity compliance guidance available
Medication errors - the "look-alike/sound alike" problem: name confusion
Medication errors: esmolol - another fatal case
Veterinary medicine
Carbaril in veterinary medicines - temporary suspension extended
Metronidazole in veterinary medicines - suspension extended
New variant CJD and plasma-derived medicinal products: TSEs - position statement
Professional Flexible Labelling of Antimicrobial Drugs - draft guidance available
Robenidine and bacitracin - approved for prevention of coccidiosis
WHO Pharmaceuticals Newsletter 1998, No. 03&04
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