Portugal. The Portuguese regulatory body, Infarmed, has suspended cold and flu products containing the decongestant phenylpropanolamine (PPA), while it reviews PPA's risk/benefit profile following worldwide concerns of cerebral haemorrhage and other adverse reactions. It may be recalled that PPA-containing products were withdrawn in several countries following the publication of an article (N Eng J of Med, 2000; 343: 1826-32) that reported a risk of haemorrhagic stroke associated with the use of PPA. (Also see WHO Pharmaceuticals Newsletters No. 4, 1996 and No. 5, 2004).
Boletim de Farmaco Vigilancia, 2005, 9(2).