Certain cold remedies and appetite suppressants, including
some that have been popular in America for more than 50
years, were withdrawn from sale after U.S. regulators
announced that they planned to ban all use of the active
ingredient in the products called phenylpropanolamine, or
PPA.
The ingredient has recently been linked to a slight risk of
stroke in young women. Officials at the U.S. Food and Drug
Administration warned consumers against taking any product
containing the chemical.
The products covered by the warning included Alka-Seltzer,
Dimetapp, Robitussin, Contac and Triaminic as well as many
generic cold remedies, some prescription decongestants and
some products for children. Acutrim and Dexatrim, both
appetite suppressants, also contain the ingredient.
Officials at the drug agency went beyond the recommendation
of an outside panel of experts, which recently called for
PPA to be removed from over-the-counter drugs. Instead, the
agency asked the manufacturers to stop marketing them
voluntarily while regulators draft new rules that would
effectively ban the ingredient.
Major American drug sellers are removing phenylpropanolamine
products from their shelves. And the drug makers SmithKline
Beecham and Bristol-Myers Squibb said that they would no
longer market cold remedies containing the chemical.
Many commented that the drug has been used and appeared safe
for some 50 years. They questioned the F.D.A. move but said
that they would certainly comply with the directives.
Phenylpropanolamine, which is similar in structure to
amphetamine, has been on the market for more than 50 years,
although there have long been concerns about its safety.
Until now, however, the F.D.A. has said there was not enough
scientific evidence to justify removing it from the
market.
The latest moves are based on a five-year study by
scientists at Yale University, who recently reported that
PPA was associated with a small, but significant, increase
in the risk of stroke among young women.
Products affected include various Alka-Seltzer Plus
medicines, some Contac 12 hour products, and Coricidin 'D'
Cold, Flu & Sinus. Phenylpropanolamine or PPA should be
listed as the active ingredient on any medicine that
contains it.
