|
|
[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]
[e-drug] Regulatory decisions in a globalised world
- Subject: [e-drug] Regulatory decisions in a globalised world
- From: "Kirsten Myhr" <kirsten.myhr@relis.ulleval.no>
- Date: Mon, 11 Nov 2002 23:12:39 -0500 (EST)
E-drug: Regulatory decisions in a globalised world
---------------------------------------------
Dear E-druggers,
Below is the abstract of an article by Albert Figueras (E-farmacos
moderator) and Joan-Ramon Laporte about the effect of the decision by FDA to
withdraw phenylpropanolamine on the situation in Latin America. As well as
being an interesting piece, it gives a lot of publicity to E-drug and
E-farmacos! Unfortunately that does not show in the abstract but in the text
they start by referring to a message Public Citizen published on E-drug 14
October 2000, and they continue to quote from the successive messages.
(Phenylpropanolamine has still not been withdrawn in Scandinavia....)
Kirsten
Figueras A, Laporte J. Regulatory decisions in a globalised world: the
domino effect of phenylpropanolamine withdrawal in Latin America. Drug Saf
2002; 25(10): 689-93.
Fundacio Institut Catala de Farmacologia, Departament de Farmacologia,
Terapeutica i Toxicologia, Universitat Autonoma de Barcelona, Hospital
Universitari Vall d'Hebron, Barcelona, Spain.
Rapid drug regulatory decisions regarding phenylpropanolamine
(PPA)-containing common cold remedies and diet pills were taken in some
Latin American countries following a US Food and Drug Administration (FDA)
decision in the US. This situation is described as one that illustrates the
important changes that regulatory decisions are experiencing as a
consequence of globalisation. The evidence for the efficacy of PPA as a
nasal decongestant and as an appetite-suppressant is very limited, at least
by modern standards. Its potential to increase blood pressure and induce
haemorrhagic stroke was described soon after its marketing. Although this
poor benefit/risk ratio had been known for more than 20 years, regulatory
action was taken in Latin America only after the US FDA withdrew the drug in
the US on the basis of the results of a case-control study which added
limited new evidence to the already known risk of stroke, but which, on the
other hand, had attracted much attention from the media.
PMID: 12167064 [PubMed - in process]
-------------------------------------
Kirsten Myhr, MScPharm, MPH
Head, RELIS Ost Drug Information Centre
Ulleval University Hospital
0407 OSLO, Norway
Tel: +47 23 01 64 11 Fax: +47 23 01 64 10
kirsten.myhr@relis.ulleval.no (w)
www.relis.no
--
To send a message to E-Drug, write to: e-drug@usa.healthnet.org
To subscribe or unsubscribe, write to: majordomo@usa.healthnet.org
in the body of the message type: subscribe e-drug OR unsubscribe e-drug
To contact a person, send a message to: e-drug-help@usa.healthnet.org
Information and archives: http://www.essentialdrugs.org/edrug
|