WHO Pharmaceuticals Newsletter 1998, No. 03&04
(1998; 18 pages)
Table des matières
Fermer ce répertoireRegulatory actions
Afficher le documentAluminium in total parenteral nutrition - labelling requirements & warning
Afficher le documentAstemizole - warning concerning cardiovascular adverse events
Afficher le documentBromfenac - warning label: liver damage
Afficher le documentCarbamazepine - warning concerning precipitation
Afficher le documentChlormezanone - withdrawn
Afficher le documentCounterfeit drugs - warning to the public
Afficher le documentDietary supplement "Sleeping Buddha" - warning concerning estazolam content
Afficher le documentFenfluramine - withdrawn
Afficher le documentHuman dura mater (freeze-dried) - restrictive measures
Afficher le documentIsotretinoin - psychiatric adverse effects
Afficher le documentPyrithione zinc (Skin-CapR) - withdrawn
Afficher le documentSertindole - approval application withdrawn
Afficher le documentTerfenadine - additional drug interactions
Afficher le documentTerfenadine - withdrawn following approval of fexofenadine
Ouvrir ce répertoire et afficher son contenuDrug surveillance
Ouvrir ce répertoire et afficher son contenuNew developments
Afficher le documentRecent approvals
Ouvrir ce répertoire et afficher son contenuMedical devices
Ouvrir ce répertoire et afficher son contenuGeneral information
Ouvrir ce répertoire et afficher son contenuVeterinary 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Terfenadine - withdrawn following approval of fexofenadine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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Le Portail d'information - Médicaments essentiels et produits de santé a été conçu et est maintenu par l'ONG Human Info. Dernière mise à jour: le 29 octobre 2018