The 16 voting members of the Nonprescription Drugs Advisory Committee (NDAC) all voted “no” on the question of whether current scientific data support the use of oral phenylephrine as a nasal decongestant.
Phenylephrine can be found in over-the-counter products like Sudafed PE Maximum Strength Congestion & Sinus Pressure Relief Tablets, Benadryl Allergy Plus Congestion Ultratabs as well in combination with other active ingredients like in Vicks NyQuil Severe Cold & Flu Relief Liquid.
It is among the most popular decongestants, but evidence presented over the course of the two-day meeting showed that while phenylephrine appeared to be safe as a medication, it demonstrated no effect on nasal congestion.
In a 2015 study presented on Monday, no statistically significant difference was found between study participants who received phenylephrine and a placebo and no meaningful difference was observed between different doses of the drug.
While committee members expressed concerns over allowing a product with dubious effectiveness to remain on the market, the vote on Tuesday will not immediately impact the availability of medications containing phenylephrine.
Most medications are withdrawn from the market in the U.S. due to a request from the manufacturer or the FDA’s request out of concern for public health.
The Consumer Healthcare Products Association (CHPA) — a trade group which represents the makers of over-the-counter (OTC) drugs, dietary supplements and consumer medical devices — said it was “disappointed” by the committee’s vote.
“We encourage FDA, before making any regulatory determination, to be mindful of the totality of the evidence supporting this long-standing OTC ingredient, as well as the significantly negative unintended consequences associated with any potential change in oral PE’s regulatory status,” CHPA President and CEO Scott Melville said in a statement.
