FDA
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Susan M. Cruzan: 301-443-3285
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FDA Proposes to Withdraw Seldane Approval

FDA recently approved Allegra, which contains fexofenadine, the primary active derivative of terfenadine produced in the body when terfenadine is taken. Fexofenadine provides nearly all of terfenadine's beneficial effects but does not appear to cause a potentially fatal heart condition when taken with some other commonly prescribed medications.

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Introduced in l985, terfenadine is marketed by Hoechst Marion Roussel of Kansas City, Mo., and was the first prescription antihistamine to relieve the symptoms of allergic rhinitis without causing drowsiness. Following approval, FDA received reports of serious and sometimes fatal cardiac arrhythmias associated with terfenadine when it was taken with - some other medications or by patients with liver disease. These other drugs, such as erythromycin (an antibiotic) and ketoconozole (an antifungal drug), can cause terfenadine build up in the blood and result in serious cardiac side effects.

Since the serious cardiac risks of terfenadine were identified, several educational campaigns have been launched by the drug's sponsor and FDA to inform health care providers and patients about the dangers of these drug interactions. These have included FDA warning statements, labeling changes and "Dear Doctor" letters. Although these efforts have reduced inappropriate prescribing and dispensing of terfenadine with other drugs, such events have not been, and almost certainly cannot be, eliminated.

Prior to the approval of Allegra, the agency considered the benefits of terfenadine to outweigh its risks despite its known serious cardiac adverse effects when used inappropriately. Hoescht Marion Roussel developed Allegra, which was approved in July l996. Now that Allegra is available and provides the therapeutic benefits of terfenadine without the associated serious cardiac risks, terfenadineþs benefits are no longer considered to outweigh its risks.

In view of these developments, FDA has determined that terfenadine-containing products should be removed from the market. Today's Notice of Opportunity for Hearing gives the manufacturers of these products 30 days to request a hearing to show why approval of the NDAs (or ANDA for the generic version) should not be withdrawn.

In the meantime, FDA is advising patients currently taking Seldane, Seldane-D and generic terfenadine products to talk to their doctor about switching to alternative medications.

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