E-DRUG: Terfenadine withdrawn from the U.S. market

[srahmad@essential.org]

E-DRUG: Terfenadine withdrawn from the U.S. market
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T98-10                      Ivy Fleischer Kupec:  301-827-6242
Feb. 27, 1998               Broadcast Media:      301-827-3434
                            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SELDANE AND GENERIC TERFENADINE WITHDRAWN FROM MARKET 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.

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