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.






T97-47                      Ivy Fleischer Kupec:  301-827-6242
Sept. 24, 1997              
                            Consumer Inquiries:   800-532-4440



                    SELDANE LABELING CHANGES

     The makers of the antihistamine Seldane and the
antihistamine/decongestant Seldane-D, are adding new warning
information to the products' labeling.
     Terfenadine-containing products, such as Seldane and
Seldane-D, have long been associated with severe risks when taken
with certain antibiotics and antifungals.  The new labeling
provides information about a new contraindication of
simultaneously using Seldane/Seldane-D with the recently approved
hypertension drug, Posicor (mibefradil dihydrochloride).  
     The new labeling also provides additional warnings against
using Seldane/Seldane-D with a number of other newer drugs. 
These include: HIV protease inhibitors such as Crixivan
(indinavir), Norvir (ritonavir), Invirase (saquinavir) and
Viracept (nelfinavir), and serotonin reuptake inhibitors such as
Luvox (fluvoxamine), Zoloft (sertaline), Serzone (nefazodone),
along with the additional medications Zyflo (zileuton), Propulsid
(cisapride) and Zagam (sparfloxacin).
     Additionally, the new labeling specifies that patients with
renal difficulties should not take more than one Seldane/
Seldane-D tablet daily and that Seldane/Seldane-D should not be
taken with grapefruit juice.
     In January, FDA proposed removing all terfenadine products 
from the marketplace because of the approval of a safer 
alternative drug: Allegra (fexofenadine hydrochloride). 
Fexofenadine hydrochloride provides the benefits of terfenadine,
but it does not cause a potentially fatal heart condition when
taken with some other commonly prescribed medications.
     The new warnings are designed to give health care providers
and consumers who still use terfenadine-containing products the
latest available information about these risks, while FDA
continues with the process to remove these products from the
market.
     In the event of terfenadine-related adverse events, health
care providers are urged to contact the manufacturer, Hoechst
Marion Roussel Inc., at 1-800-633-1610 or FDA MedWatch at (phone)
1-800-FDA-1088, (fax) 1-800-FDA-1078, (modem) 1-800-FDA-7737 or
(mail) FDA, HF-2, 5600 Fishers Lane, Rockville, MD 20857.
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