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The US Food and Drug Administration (FDA) has proposed the removal of oral phenylephrine as an active ingredient that can be used in over-the-counter medicines for management of nasal congestion.

This comes after a close evaluation of efficacy data that proved oral phenylephrine is not effective as a nasal decongestant.

FDA thoroughly reviewed all of the information that was available regarding the safety and effectiveness of oral phenylephrine, including the more recent clinical data.

Additionally, the agency assessed the historical data that was utilized to support the conclusion that oral phenylephrine was effective as a nasal decongestant thirty years ago.

Phenylephrine is an alpha-1 adrenergic agonist commonly included in many coughs and cold formulations, either as the only active ingredient or in combination with other molecules, including analgesics.

Its inclusion is aimed to induce temporary relief from flu symptoms, including congestion and breathing difficulties.

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The drug is also available as a nasal spray in management of congestion; however, at this time, the FDA is more concerned about the oral formulations.

“Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”

 

Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER)

The authority has encouraged stakeholders to submit comments on this proposal and will only move forward to issue an order to remove oral phenylephrine as a nasal decongestant after considering the feedback.

Instructions on how to submit comments can be found here.

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