A Food and Drug Administration (FDA) advisory committee unanimously voted Tuesday that current scientific data does not support the use of the active ingredient in over-the-counter products like Sudafed and Benadryl for decongestion.
The FDA’s Nonprescription Drugs Advisory Committee was asked to vote on the question of whether evidence supported the oral use of phenylephrine as an effective nasal decongestant.
As an over-the-counter medication, phenylephrine is sold in products like Sudafed PE Sinus Congestion as well as Benadryl Allergy Plus Congestion ULTRATABS. It can also be found in liquid or strip versions and is recognized as “safe and effective” under the FDA’s standards.
Among the advisory committee voting members present during Tuesday’s meeting, all 16 voted “no” on the question of its efficacy.
The impact that the possible removal of phenylephrine products would have on the market was discussed at length during the meeting.
Committee member Maryann Amirshahi said during the meeting that if phenylephrine products are removed from the market, it should be emphasized that it was “more of an efficacy issue as opposed to a safety issue.”
It was noted during the meeting that when the advisory committee convened a meeting on phenylephrine in 2007, the study results that were presented were not consistent and did not meet current trial design standards.
At the time, the majority of the committee also voted that additional studies were needed to assess safety and efficacy.
As the academic journal Science noted in 2022, oral phenylephrine is “extensively metabolized” in the gut and the standard 10 mg dose available over the counter has been shown to have a fairly low bioavailability.
