ASMI says new information on Phenylephrine interesting but of limited value

20 March 2014

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 20 March 2014 - The Australian Self Medication Industry (ASMI) today said that new information on the pharmacokinetics of Phenylephrine (PE) published in theNew England Journal of Medicine(NEJM) is certainly interesting, but of limited value. 

ASMI was commenting on a Letter to the Editor 1 in the NEJM which purports to show that the absorption of PE into the body can be influenced by paracetamol (if the two ingredients are taken together). 

"It is important to note that the new information is in the form of a Letter to the NEJM Editor from AFT pharmaceuticals. It is not the publication of a full study, said Steve Scarff, ASMI Director of Scientific and Regulatory Affairs. 

Mr Scarff commented that: "There are many important questions which remain unanswered, for example:

  • When and where was the study conducted?
  • How many participants were involved?
  • What were the participants like?
  • What were the precise details of the study design?
  • Did participants taking the combination product experience different side effects to those taking the single ingredient?
  • Was the reduced dose of PE less effective at relieving symptoms?

"Until we see the full details of the study, it is difficult to assess its merits or its potential impact.

"Despite this, ASMI applauds AFT for making the full details available to the Therapeutic Goods Administration (TGA) and other regulators. The TGA will be able to review the full set of AFT's data against the existing evidence and the reports they receive from consumers, healthcare professionals and companies about medicines on the Australian market. The TGA is therefore in the best position to determine the importance of this new information.

"Phenylephrine has a long history of safe use in Australia and other regulated markets.

"Consumers can continue to use these products according to the label instructions, but if they have any concerns they should speak with their healthcare professional," says Mr Scarff. 2

 

For more information or to arrange a media interview, please contact: Marie Kelly-Davies

PR Manager, Australian Self Medication Industry (ASMI)

M:0408 256 381 E: marie@asmi.com.au