WHO Pharmaceuticals Newsletter 1998, No. 03&04
(1998; 18 pages)
Índice de contenido
Cerrar esta carpetaRegulatory actions
Ver el documentoAluminium in total parenteral nutrition - labelling requirements & warning
Ver el documentoAstemizole - warning concerning cardiovascular adverse events
Ver el documentoBromfenac - warning label: liver damage
Ver el documentoCarbamazepine - warning concerning precipitation
Ver el documentoChlormezanone - withdrawn
Ver el documentoCounterfeit drugs - warning to the public
Ver el documentoDietary supplement "Sleeping Buddha" - warning concerning estazolam content
Ver el documentoFenfluramine - withdrawn
Ver el documentoHuman dura mater (freeze-dried) - restrictive measures
Ver el documentoIsotretinoin - psychiatric adverse effects
Ver el documentoPyrithione zinc (Skin-CapR) - withdrawn
Ver el documentoSertindole - approval application withdrawn
Ver el documentoTerfenadine - additional drug interactions
Ver el documentoTerfenadine - withdrawn following approval of fexofenadine
Abrir esta carpeta y ver su contenidoDrug surveillance
Abrir esta carpeta y ver su contenidoNew developments
Ver el documentoRecent approvals
Abrir esta carpeta y ver su contenidoMedical devices
Abrir esta carpeta y ver su contenidoGeneral information
Abrir esta carpeta y ver su contenidoVeterinary medicine

Terfenadine - withdrawn following approval of fexofenadine

United States of America. The manufacturer has announced its plans to remove products containing terfenadine (SeldaneR and Seldane-DR: Hoechst Marion Roussel) from the market following the approval by the FDA of the prescription antihistamine/decongestant fexofenadine/pseudoephedrine (Allegra-DR: Hoechst Marion Roussel), extended release tablet. The monocomponent formulation of fexofenadine (AllegraR) has already been approved by the FDA.

Fexofenadine is the primary active derivative of terfenadine. It provides nearly all of terfenadine's beneficial effects but, unlike terfenadine, fexofenadine does not appear to cause a potentially fatal heart condition when taken with some other commonly prescribed medications.

[See also Pharmaceuticals Newsletter Nos. 11&12, November&December 1997 and DRS Alert No. 54 dated 16 January 1997]

Reference: FDA Talk Paper T97-67 dated 29 December 1997.


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