Phenylpropanolamine and hemorrhagic stroke

Michael E. Ernst; Arthur Hartz; William R. Wolowich; Marcel J. Casavant; Brent R. Ekins; Walter N. Kernan; Catherine M. Viscoli; Lawrence M. Brass; Ralph I. Horwitz; G. Alexander Fleming

doi:10.1056/NEJM200104053441411

Phenylpropanolamine and hemorrhagic stroke

Michael E. Ernst
, Arthur Hartz
, William R. Wolowich
, Marcel J. Casavant
, Brent R. Ekins
, Walter N. Kernan
, Catherine M. Viscoli
, Lawrence M. Brass
, Ralph I. Horwitz
, G. Alexander Fleming

Research output: Contribution to journal › Letter › peer-review

Abstract

The request by the Food and drug Administration (FDA) for the voluntary withdrawal of all products containing phenylpropanolamine on the basis of the data of Kernan et al (Dec. 21 issue) is excessive. Although the study was rigorously designed and the data compelling with respect to the risk of hemorrhagic stroke with this agent, it does not provide justification for the withdrawal of all products containing phenylpropanolamine, particularly decongestant preparations that have been used safely in prescription and nonprescription products for many years.

Original language	English
Pages (from-to)	1094-1095
Number of pages	2
Journal	New England Journal of Medicine
Volume	344
Issue number	14
DOIs	https://doi.org/10.1056/NEJM200104053441411
State	Published - Apr 5 2001
Externally published	Yes

ASJC Scopus Subject Areas

General Medicine

Keywords

Appetite Depressants/administration & dosage
Cerebral Hemorrhage/chemically induced
Drug Approval
Female
Humans
Male
Nasal Decongestants/adverse effects
Phenylpropanolamine/administration & dosage
Risk Factors
Sex Factors
Substance-Related Disorders
United States
United States Food and Drug Administration

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10.1056/NEJM200104053441411

Cite this

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title = "Phenylpropanolamine and hemorrhagic stroke",

abstract = "The request by the Food and drug Administration (FDA) for the voluntary withdrawal of all products containing phenylpropanolamine on the basis of the data of Kernan et al (Dec. 21 issue) is excessive. Although the study was rigorously designed and the data compelling with respect to the risk of hemorrhagic stroke with this agent, it does not provide justification for the withdrawal of all products containing phenylpropanolamine, particularly decongestant preparations that have been used safely in prescription and nonprescription products for many years.",

keywords = "Appetite Depressants/administration \& dosage, Cerebral Hemorrhage/chemically induced, Drug Approval, Female, Humans, Male, Nasal Decongestants/adverse effects, Phenylpropanolamine/administration \& dosage, Risk Factors, Sex Factors, Substance-Related Disorders, United States, United States Food and Drug Administration",

author = "Ernst, \{Michael E.\} and Arthur Hartz and Wolowich, \{William R.\} and Casavant, \{Marcel J.\} and Ekins, \{Brent R.\} and Kernan, \{Walter N.\} and Viscoli, \{Catherine M.\} and Brass, \{Lawrence M.\} and Horwitz, \{Ralph I.\} and Fleming, \{G. Alexander\}",

year = "2001",

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day = "5",

doi = "10.1056/NEJM200104053441411",

language = "English",

volume = "344",

pages = "1094--1095",

journal = "New England Journal of Medicine",

issn = "0028-4793",

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TY - JOUR

T1 - Phenylpropanolamine and hemorrhagic stroke

AU - Ernst, Michael E.

AU - Hartz, Arthur

AU - Wolowich, William R.

AU - Casavant, Marcel J.

AU - Ekins, Brent R.

AU - Kernan, Walter N.

AU - Viscoli, Catherine M.

AU - Brass, Lawrence M.

AU - Horwitz, Ralph I.

AU - Fleming, G. Alexander

PY - 2001/4/5

Y1 - 2001/4/5

N2 - The request by the Food and drug Administration (FDA) for the voluntary withdrawal of all products containing phenylpropanolamine on the basis of the data of Kernan et al (Dec. 21 issue) is excessive. Although the study was rigorously designed and the data compelling with respect to the risk of hemorrhagic stroke with this agent, it does not provide justification for the withdrawal of all products containing phenylpropanolamine, particularly decongestant preparations that have been used safely in prescription and nonprescription products for many years.

AB - The request by the Food and drug Administration (FDA) for the voluntary withdrawal of all products containing phenylpropanolamine on the basis of the data of Kernan et al (Dec. 21 issue) is excessive. Although the study was rigorously designed and the data compelling with respect to the risk of hemorrhagic stroke with this agent, it does not provide justification for the withdrawal of all products containing phenylpropanolamine, particularly decongestant preparations that have been used safely in prescription and nonprescription products for many years.

KW - Appetite Depressants/administration & dosage

KW - Cerebral Hemorrhage/chemically induced

KW - Drug Approval

KW - Female

KW - Humans

KW - Male

KW - Nasal Decongestants/adverse effects

KW - Phenylpropanolamine/administration & dosage

KW - Risk Factors

KW - Sex Factors

KW - Substance-Related Disorders

KW - United States

KW - United States Food and Drug Administration

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U2 - 10.1056/NEJM200104053441411

DO - 10.1056/NEJM200104053441411

M3 - Letter

C2 - 11291666

AN - SCOPUS:0035810153

SN - 0028-4793

VL - 344

SP - 1094

EP - 1095

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 14

ER -

Phenylpropanolamine and hemorrhagic stroke

Abstract

ASJC Scopus Subject Areas

Keywords

Access to Document

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