National Medicines Symposium 2024 speakers (L to R): Steve Waller, Professor Jennifer Martin, Professor Libby Roughead, Tegan Taylor[/caption]
This CPD activity is sponsored by Reckitt. All content is the true, accurate and independent opinion of the speakers and the views expressed are entirely their own.[/caption]
The TGA is aware that the US Food and Drug Administration’s (FDA) Nonprescription Drugs Advisory Committee met in September 2023 to discuss the available efficacy data for oral phenylephrine used as a nasal decongestant and whether it should be reclassified from being ‘Generally Recognized as Safe and Effective’ (GRASE) due to its efficacy. The FDA’s advisory committee makes non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so.
The TGA is not aware that the FDA has identified safety concerns or made a decision that phenylephrine is ineffective. At this time, the TGA has no plans to conduct a review of the effectiveness of oral phenylephrine but will continue to monitor the outcomes of the FDA review.
In Australia, medicines containing phenylephrine are required to be ‘registered’ in the Australian Register of Therapeutic Goods (ARTG). Medicines that are registered in the ARTG have an AUST R number on their medicine label. The full formulations of these medicines undergo an evaluation and approval by the TGA for safety, quality, and efficacy before they can be sold to consumers. The TGA Delegate considers all current information to ensure the benefits of the medicine outweigh the risks before approving a medicine.
Phenylephrine has a long history of use in cough and cold medicines and its safety and efficacy has been documented in standard reference texts. However, the perceived effectiveness of medications indicated to relieve symptoms such as nasal congestion can vary between individuals.
The TGA is constantly monitoring actions taken by, and communicating with, comparable overseas regulators and will take action as required. Further, as new scientific information becomes available ingredients may undergo further evaluation to consider the risk benefit profile. Sponsors are required to notify the TGA when they become aware of significant new information about the safety, quality or efficacy of a medicine.
Australian legislation requires that the active ingredient is displayed prominently on the main label of the medicine to enable consumers to make informed choices when purchasing over-the-counter medicines.
