E-MED: phenylpropalamine (3)
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Pour votre information les deux messages de e-drug concernant ce sujet.
La revue Prescrire avait fait un article intitul� "Accidents cardiaques et
neurologiques dus � la ph�nylpropanolamine " "dans sa rubrique "Vigilances"
dans le num�ro 198 dut tome 19 en septembre 1999.
En r�um� il �tait dit :
"La ph�nylproponolamine alias nor�ph�drine, est un sympathomim�tique
vasoconstricteur tr�s voisin de l'amph�tamine, qui expose � un risque
d'accidents cardiaques, neurologiques et psychiatriques, parfois grave.
La pr�sence de ph�nylproponolamine dans de nombreuses sp�cialit� disponibles
sans prescription ne doit pas faire banaliser cette substance. La
prescription de ph�nylproponolamine au sein de pr�parations magistrales �
vis�e amaigrissante doit attirer l'attention des pharmaciens."
En France ce produit se trouve notamment dans Actifed�, Chronotrophir�,
D�noral�, Efy Etat grippal�, Fevex Rhume�, Humex�, Rhinofeb�, Rinurel�,
Rinuran�, Rupton chronules, Triaminic�... (liste non exclusive)
Carinne Bruneton
ReMeD
remed@remed.org
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.
E-drug: Petition to Ban Phenylpropanolamine as an OTC Drug in the US
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Dear Colleagues,
This morning (19 Oct 00) we presented testimony before the Food and
Drug Administration's (FDA) Non-Prescription Drugs Advisory Committee
about the safety of phenylpropanolamine (PPA) and petitioned the FDA
to immediately remove this drug from over-the-counter status in the
U.S. because of an increased the risk of hemorrhagic stroke. PPA is
used in both over-the-counter appetite suppressants and cough/cold
remedies in this country.
There is an extensive body of published reports describing the
dangers of PPA. In addition, an industry-funded case-control study
conducted at Yale University recently supported the observations that
PPA increases the risk for hemorrhagic stroke. This study can be
found on the FDA's web site at:
www.fda.gov/ohrms/dockets/ac/cder00.htm#Nonprescription.
Click on the briefing information for 10/19 and the study will be
found as Tab 20.
FDA documents available on the Internet at the same address given
above indicate that the agency believes PPA should be removed from
over-the-counter status.
Our testimony and petition can be found on Public Citizen's web site at:
www.citizen.org/hrg/publications/1541.htm and
www.citizen.org/hrg/publications/1542.htm.
We urge colleagues in other countries to use our materials and those
prepared by the FDA to eliminate the use of PPA in all
over-the-counter products. We would also like to thank the
individuals who took the time to provide us with information about
the regulatory status of PPA in their countries.
Best regards,
Larry
Larry D. Sasich, Pharm.D., M.P.H., FASHP
Public Citizen's Health Research Group
1600 20th Street, NW
Washington, DC 20009
Voice: 202-588-7782
FAX: 202-588-7793
E-Mail: lsasich@citizen.org
Web Site: www.citizen.org/hrg
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