Discover FDA Advisers’ Surprising Verdict: Sudafed Fails as a Decongestant, Benadryl Ineffective

In a unanimous vote on Tuesday, the Food and Drug Administration (FDA) advisory committee concluded that there is insufficient scientific evidence to support the use of phenylephrine, the active ingredient in popular over-the-counter products such as Sudafed and Benadryl, as a nasal decongestant.

The FDA’s Nonprescription Drugs Advisory Committee specifically voted on whether there is enough evidence to endorse the oral use of phenylephrine as an effective nasal decongestant.

Phenylephrine is currently found in various forms, including Sudafed PE Sinus Congestion and Benadryl Allergy Plus Congestion ULTRATABS. It is recognized as “safe and effective” by the FDA’s standards.

All 16 voting members of the advisory committee present at the meeting voted “no” on the question of phenylephrine’s efficacy as a nasal decongestant.

During the meeting, the impact of potentially removing phenylephrine products from the market was extensively discussed.

Committee member Maryann Amirshahi emphasized that if phenylephrine products were to be removed, it should be viewed as an efficacy issue rather than a safety concern.

The meeting also highlighted that the study results presented during a previous advisory committee meeting on phenylephrine in 2007 were inconsistent and did not meet current trial design standards. The majority of the committee at that time voted in favor of conducting additional studies to evaluate safety and efficacy.

As noted by the academic journal Science in 2022, oral phenylephrine undergoes extensive metabolism in the gut, and the standard 10 mg dose available over the counter has demonstrated low bioavailability.