[e-drug] Petition to Ban Phenylpropanolamine as an OTC Drug in the US

e-drug
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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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