Inpharma 1070 - 18 Jan 1997 Terfenadine alert in the US Withdrawal of the approval of the prescription antihistamine terfenadine [both brand name (Hoechst Marion Roussel’s ‘Seldane’ and ‘Seldane-D) and generic versions] is being considered by the US FDA in view of the availability of fexofenadine. 1 The use of terfenadine has been associated with adverse cardiac effects in patients with liver disease and those taking certain concomitant medications, such as erythromycin or ketoconazole. The FDA recently approved the primary active derivative of terfenadine, fexofenadine [‘Allegra’; Hoechst Marion Roussel], * which provides nearly all of the therapeutic benefits of terfenadine without the risk of potentially fatal adverse cardiac effects. – US FDA News, http//www.fda.gov; 15 Jan 1997 Hoechst Marion Roussel quick to respond Hoechst Marion Roussel has marketed fexofenadine in the US since August 1996 for the treatment of seasonal allergic rhinitis. The company responded swiftly to the potential withdrawal of terfenadine, announcing a promotional campaign to switch terfenadine users to the new fexofenadine product. 2 Both terfenadine and fexofenadine are nonsedating antihistamines. Meanwhile, Hoechst Marion Roussel maintains that terfenadine is safe and effective when used according to package insert instructions. – PR Newswire, http:// www.newspage.com 15 Jan 1997 * See Inpharma 1054: 22, 14 Sep 1996; see Inpharma 1054 p22; 800468329 1. FDA proposes to withdraw Seldane approval. Reactions 634: 18 Jan 1997. 2. Hoechst Marion Roussel launches switch campaign for Allegra (Rm). Reactions 634: 18 Jan 1997. 800458330 1 Inpharma 18 Jan 1997 No. 1070 1173-8324/10/1070-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Terfenadine alert in the US

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Inpharma 1070 - 18 Jan 1997

Terfenadine alert in the USWithdrawal of the approval of the prescription

antihistamine terfenadine [both brand name (HoechstMarion Roussel’s ‘Seldane’ and ‘Seldane-D) and genericversions] is being considered by the US FDA in view ofthe availability of fexofenadine.1

The use of terfenadine has been associated withadverse cardiac effects in patients with liver disease andthose taking certain concomitant medications, such aserythromycin or ketoconazole.

The FDA recently approved the primary activederivative of terfenadine, fexofenadine [‘Allegra’;Hoechst Marion Roussel],* which provides nearly all ofthe therapeutic benefits of terfenadine without the riskof potentially fatal adverse cardiac effects. – US FDANews, http//www.fda.gov; 15 Jan 1997

Hoechst Marion Roussel quick to respondHoechst Marion Roussel has marketed fexofenadine

in the US since August 1996 for the treatment ofseasonal allergic rhinitis.

The company responded swiftly to the potentialwithdrawal of terfenadine, announcing a promotionalcampaign to switch terfenadine users to the newfexofenadine product.2 Both terfenadine andfexofenadine are nonsedating antihistamines.

Meanwhile, Hoechst Marion Roussel maintains thatterfenadine is safe and effective when used according topackage insert instructions. – PR Newswire, http://www.newspage.com 15 Jan 1997* See Inpharma 1054: 22, 14 Sep 1996; see Inpharma 1054 p22;800468329

1. FDA proposes to withdraw Seldane approval. Reactions 634: 18 Jan 1997.2. Hoechst Marion Roussel launches switch campaign for Allegra (Rm). Reactions

634: 18 Jan 1997.800458330