(1998; 18 pages)
Terfenadine - withdrawn following approval of fexofenadine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.