E-DRUG: U.S. FDA's Talk Paper on Terfenadine withdrawal
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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 (1997), 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.
Note from the moderator:
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A company statement said "Hoechst Marion Roussel will discontinue the
sale and distribution of Seldane and Seldane-D in the US market on
February 1, 1998."
Syed Rizwanuddin Ahmad
Email: srahmad@essential.org
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