Drug Safety

, Volume 25, Issue 10, pp 689–693

Regulatory Decisions in a Globalised World

The Domino Effect of Phenylpropanolamine Withdrawal in Latin America
Current Opinion

DOI: 10.2165/00002018-200225100-00001

Cite this article as:
Figueras, A. & Laporte, J. Drug-Safety (2002) 25: 689. doi:10.2165/00002018-200225100-00001

Abstract

Rapid drug regulatory decisions regarding phenylpropanolamine (PPA)-containing common cold remedies and diet pills were taken in some Latin American countries following a 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.

Copyright information

© Adis International Limited 2002

Authors and Affiliations

  1. 1.Fundació Institut Català de Farmacologia, Departament de Farmacologia, Terapèutica i ToxicologiaUniversitat Autònoma de Barcelona, Hospital Universitari Vall d’HebronBarcelonaSpain