WHO Pharmaceuticals Newsletter 1998, No. 03&04
(1998; 18 pages)
Table of Contents
Close this folderRegulatory actions
View the documentAluminium in total parenteral nutrition - labelling requirements & warning
View the documentAstemizole - warning concerning cardiovascular adverse events
View the documentBromfenac - warning label: liver damage
View the documentCarbamazepine - warning concerning precipitation
View the documentChlormezanone - withdrawn
View the documentCounterfeit drugs - warning to the public
View the documentDietary supplement "Sleeping Buddha" - warning concerning estazolam content
View the documentFenfluramine - withdrawn
View the documentHuman dura mater (freeze-dried) - restrictive measures
View the documentIsotretinoin - psychiatric adverse effects
View the documentPyrithione zinc (Skin-CapR) - withdrawn
View the documentSertindole - approval application withdrawn
View the documentTerfenadine - additional drug interactions
View the documentTerfenadine - withdrawn following approval of fexofenadine
Open this folder and view contentsDrug surveillance
Open this folder and view contentsNew developments
View the documentRecent approvals
Open this folder and view contentsMedical devices
Open this folder and view contentsGeneral information
Open this folder and view contentsVeterinary 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Terfenadine - withdrawn following approval of fexofenadine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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