E-DRUG: FDA: Phenylpropanolamine unsafe
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FDA panel: popular decongestant ingredient unsafe
Stroke risk cited
October 19, 2000
WASHINGTON (CNN) -- An advisory committee for the Food
and Drug Administration agreed Thursday that an
ingredient commonly used in over-the-counter diet aids
and decongestants is unsafe, and it plans to recommend
further review by the FDA.
The FDA Non-Prescription Drugs Advisory Committee met
Thursday to discuss a new five-year study by Yale
University researchers that found phenyl-propanolamine
(PPA), an active ingredient in non-prescription drugs,
can increase the risk of stroke in some users.
PPA helps constrict blood vessels, thus relieving
nasal congestion, and has been shown to aid in weight
loss. The compound is in hundreds of over-the-counter
cold, cough and allergy medicines and appetite
suppressants.
The Yale study involved 702 patients between the ages
of 18 and 49 who had suffered hemorrhagic strokes, or
bleeding in the brain. The stroke patients were
matched on the basis of age, gender, race and
geographic location with control subjects who had not
had a stroke.
The study found evidence that linked PPA to the stroke
patients, who were 50 percent more likely than the
control subjects to have used PPA within three days of
the onset of their stroke symptoms.
"I don't think there's any question in my mind that
PPA appears to increase the risk of brain hemorrhage,"
said Dr. Ralph Horwitz, lead author of the study and
chairman of internal medicine at Yale.
But the Consumer Healthcare Products Association
(CHPA), a trade association that represents
manufacturers of over-the-counter drugs and dietary
supplements and the study's funder, said the study was
"inconclusive" and did not support a challenge to the
safety of PPA in over-the-counter medicines.
"This evidence from clinical trial and adverse-event
tracking, when taken together, overwhelmingly supports
the safety and effectiveness of PPA when used as
directed on product labeling." said R. William Soller,
Ph.D. and Director of Science & Technology at CHPA.
"We strongly disagree with any broad-sweeping
statements and conclusions about the results of the
Yale study that explicitly state or imply it
represents strong epidemiologic evidence applicable to
the general population."
Reports linking PPA to hemorrhagic stroke began to
surface more than 20 years ago.
PPA is listed as an active ingredient in
over-the-counter diet products from Acutrim and
Dexatrim, and non-prescription cold medicines made by
Alka-Seltzer, BC, Comtrex, Contac, Dimetapp,
Robitussin, Tavist-D, and Triaminic, among others.
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