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. 
T97-67                      Ivy Fleischer Kupec:  301-827-6242
Dec. 29, 1997               
                            Consumer Inquiries:   800-532-4440

FDA APPROVES ALLEGRA-D, MANUFACTURER TO WITHDRAW SELDANE FROM MARKETPLACE

FDA today announced the approval of the prescription antihistimine/decongestant Allegra-D (fexofenadine/ pseudoephedrine) extended release tablet. With the approval of this drug and the prior approval of Allegra, the manufacturer has announced its plans to remove the drugs' predecessors, Seldane and Seldane-D (terfenadine-containing products), from the marketplace. The following can be used to answer questions:

Fexofenadine, an active ingredient in Allegra and Allegra-D, is the primary active derivative of terfenadine produced in the body when Seldane and Seldane-D are 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.

In January, FDA proposed removing all terfenadine products from the marketplace because of the approval of a safer alternative drug: fexofenadine. At that time, FDA advised patients currently taking Seldane, Seldane-D and generic terfenadine products to talk to their doctors about switching toalternative medications. In September, the manufacturer added increased warnings on Seldane and Seldane-D's label to give health care providers and consumers who still used terfenadine-containing products the latest available information about these risks, while FDA continued the administrative process of removing these products from the market.

Controlled clinical studies have demonstrated that the twice-daily dose of fexofenadine/pseudoephedrine combination tablet significantly reduced the intensity of sneezing, nasal congestion, and itchy nose, mouth, throat and eyes that typically appear with seasonal allergies.

Allegra-D is indicated for adults and children age 12 and older. The most common adverse events reported during clinical trials of Allegra-D included: headache (13 percent), insomnia (12.6 percent) and nausea (7.4 percent).

Allegra-D is not recommended for patients with hypertension, diabetes, ischemic heart disease, increased intraocular pressure, hyperthyroidism, kidney impairment or prostate problems. Allegra-D, like other products in the same drug class, may stimulate the nervous system with convulsions or cause cardiac collapse in these patients.

Hoechst Marion Roussel of Kansas City, Mo., manufactures Seldane, Seldane-D, Allegra and Allegra-D.

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