Patients taking drugs containing the antihistamine terfenadine--Seldane, Seldane D, and generic versions--should talk to their doctors about switching to alternative medicine, FDA advised earlier this year. The caution came as the agency took the first step toward withdrawing approval of the drug because of safety concerns.
Terfenadine's approval in 1985 made it the first prescription antihistamine to relieve allergic rhinitis without drowsiness. Since then, FDA has received reports of serious, sometimes fatal heart arrhythmias (irregular heartbeats) in users who have liver disease or take such other medicines as the antibiotic erythromycin or the antifungal drug ketoconazole. These drugs can make terfenadine build up in the blood, causing serious effects on the heart.
Efforts by FDA and the drug's sponsor, Hoechst Marion Roussel, to inform health-care providers and patients about these dangers, including FDA warning statements, labeling changes, and "Dear Doctor" letters, have reduced inappropriate prescribing and dispensing of terfenadine with certain other drugs. But FDA believes that such drug interactions almost certainly cannot be eliminated.
Initially, FDA considered that terfenadine's benefits from appropriate use outweighed the risks from inappropriate use. But in a Jan. 13 announcement, FDA said it no longer considered this true because of the availability of a new drug, Allegra (fexofenadine). Approved by FDA in July 1996, Allegra also is made by Hoechst Marion Roussel. It provides nearly all of terfenadine's benefits without the associated serious heart risk.
In view of these developments, FDA began proceedings to remove the drug from the market and advised patients taking the medicine to talk to their doctors.
COPYRIGHT 1997 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group
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