Regulatory decisions in a globalised world: the domino effect of phenylpropanolamine withdrawal in Latin America.
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.
Figueras
Albert
A
Fundació Institut Català de Farmacologia, Departament de Farmacologia, Terapèutica i Toxicologia, Universitat Autònoma de Barcelona, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Laporte
Joan-Ramon
JR
D001067:Appetite Depressants / Q000009:adverse effects*; D016022:Case-Control Studies; D006801:Humans; D007843:Latin America; D007880:Legislation, Drug; D014663:Nasal Decongestants / Q000009:adverse effects* / Q000627:therapeutic use; D010665:Phenylpropanolamine / Q000009:adverse effects* / Q000627:therapeutic use; D011358:Product Surveillance, Postmarketing; D018570:Risk Assessment; D020521:Stroke / Q000139:chemically induced; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
D001067:Appetite Depressants; D014663:Nasal Decongestants; D010665:Phenylpropanolamine