FDA APPROVES ALLEGRA-D, MANUFACTURER TO WITHDRAW SELDANE FROM MARKETPLACE
FDA
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. _
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T97-67 Ivy Fleischer Kupec: 301-827-6242
Dec. 29, 1997 Broadcast Media: 301-827-3434
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.