FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 
T98-10                      Ivy Fleischer Kupec:  301-827-6242
Feb. 27, 1998               
                            Consumer Inquiries:   800-532-4440

SELDANE AND GENERIC TERFENADINE WITHDRAWN FROM MARKET

Hoescht Marion Roussel and Baker Norton Pharmaceuticals have voluntarily discontinued distribution and marketing of all terfenadine-containing antihistamine product lines in the United States.

Terfenadine-containing products, such as Seldane and Seldane-D, have been associated with rare, but serious heart problems when taken with certain other drugs, including certain antibiotics and antifungals.

In January 1997, FDA proposed removing all terfenadine products from the marketplace because of the approval of a safer alternative drug: Allegra (fexofenadine hydrochloride). Fexofenadine hydrochloride provides exactly the same benefits of terfenadine, but it does not cause a potentially fatal heart condition when taken with certain other commonly prescribed medications. At that time, FDA advised patients currently taking Seldane, Seldane-D and generic terfenadine products to talk to their health care providers about switching to alternative medications. Following the approval of Allegra-D in December 1997 and with the prior approval of Allegra, Hoescht Marion Roussel announced its plans to discontinue distribution and marketing of the drugs' predecessors, Seldane and Seldane-D from the marketplace as of Feb. 1. Likewise, the manufacturer of generic terfenadine, Baker Norton Pharmaceuticals, also has discontinued U.S. distribution and marketing of its product.

As a result, terfenadine-containing products will soon disappear from pharmacies as existing supplies are depleted. FDA again reminds consumers and health care providers who have used these products, that equally safe and effective alternative drug products are available.

FDA will continue the administrative procedures to finalize the permanent withdrawal of all terfenadine-containing products.

####

[FDA HOME PAGE]