Drug stores move to remove cold, diet drugs after FDA warning DAVID HO, Associated Press Writer
Tuesday, November 7, 2000
Breaking News Sections
(11-07) 01:06 EST WASHINGTON (AP) -- A
number of major drug store chains are pulling dozens
of over-the-counter cold remedies and diet pills from
their shelves after the government warned that an
ingredient could cause hemorrhagic strokes, especially
in young women.
The Food and Drug Administration issued an unusually
strong warning Monday, telling Americans to
immediately quit using drugs containing
phenylpropanolamine, or PPA, which is found
Dexatrim, Tavist-D and dozens of other
over-the-counter medicines. The agency, which
intends to ban the ingredient, asked manufacturers
voluntarily to stop selling PPA-containing drugs
immediately and to replace the ingredient with a safer
alternative.
Rite Aid, with 3,800 drug stores in 30 states and the
District of Columbia, soon will begin posting warning
signs and removing products with PPA, spokeswoman
Jody Cook said.
``We would advise our customers to check with the
pharmacist about the alternatives,'' she said.
CVS Pharmacy, which has 4,100 stores, and
Walgreen Co., with 3,200 stores, made similar
announcements.
Dr. Charles Ganley, the FDA's nonprescription drugs
chief, said buyers should be alert for PPA in the
ingredient list of nonprescription cold relievers -- both
brand names and generic or store brands -- and
instead choose decongestant pills with the safe
alternative pseudoephedrine or use nasal sprays.
Over-the-counter alternatives do not exist for diet pills,
however, so dieters will have to consult doctors about
prescription-only alternatives, Ganley said.
Whitehall-Robins Healthcare quit shipping
PPA-containing Dimetapp on Monday. New liquid
Dimetapp formulas lacking PPA will head for store
shelves next week, with pill versions to follow. Also,
some stores are selling PPA-containing versions of its
Robitussin-CF product, and some are selling a new
non-PPA formula, in boxes flagged with a yellow
band.
SmithKline Beecham Consumer Healthcare said
people should not use its PPA-containing Contac
12-hour Cold Capsules, but five other Contac versions
contain the safe pseudoephedrine.
Even though manufacturers learned three weeks ago
that the FDA was preparing to act, when the agency's
scientific advisers declared PPA unsafe, many
scrambled Monday to decide what to do.
Top-selling manufacturers that refused to reveal their
plans include Novartis Corp., maker of
PPA-containing Triaminic and Tavist-D; Bayer Corp.,
maker of Alka-Seltzer Plus cold medicines; and
Chattem Inc., maker of Dexatrim diet pills.
About 6 billion doses of PPA are sold in this country
each year, mostly without prescriptions. There are a
few PPA-containing prescription decongestants, and
the FDA asked their makers also to stop selling them
while it moves to ban prescription use as well.
While the risk of a hemorrhagic stroke, or bleeding in
the brain, is very small to an individual user, these are
often deadly strokes, and survivors can be left
disabled.
With millions of Americans swallowing PPA daily, the
FDA estimated it could be to blame for 200 to 500
strokes yearly just in people under age 50.
Hemorrhagic strokes typically occur in the elderly, and
are extremely rare under age 50. In the 1980s,
however, medical journals cited several dozen young
women who suddenly had strokes days after taking
their first PPA-containing diet pill.
A five-year Yale University study comparing PPA use
among stroke survivors with healthy people concluded
that PPA increases stroke risk for young women within
three days of taking PPA-containing appetite
suppressants, or within three days of taking their
first-ever PPA dose for any reason. In some cases,
using PPA increased stroke risk 12- to 15-fold.
Nobody knows why, although first-time PPA use
sometimes temporarily raises blood pressure, an effect
that wanes as the body gets used to the drug. Risk was
highest with the higher doses -- more than 75
milligrams daily -- that dieters typically used.
The study didn't find men at risk, but the FDA
cautioned that enough men weren't studied to be sure
they're OK.
^------=
On the Net: FDA's PPA information:
fda.gov
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11/06/2000 - FDA warns
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