The 16 voting members of the Nonprescription Drugs Advisory Committee (NDAC) all voted “no” on the question of whether current scientific data supports the use of oral phenylephrine as a nasal decongestant.
Phenylephrine is found in over-the-counter products such as Sudafed PE Maximum Strength Congestion & Sinus Pressure Relief Tablets, Benadryl Allergy Plus Congestion Ultratabs as well as in combination with other active ingredients such as Vicks NyQuil Severe Cold & Flu Relief Liquid.
This includes most popular decongestantsbut evidence presented over the course of the two-day meeting showed that while phenylephrine appeared safe as a drug, it appeared to have no effect on nasal congestion.
In a 2015 study presented Monday, there was no statistically significant difference was found between study participants receiving phenylephrine and a placebo and no significant difference was observed between different doses of the drug.
While committee members expressed concerns about allowing a product with dubious efficacy to remain on the market, Tuesday’s vote will not immediately affect the availability of drugs containing phenylephrine.
Most drugs are withdrawn from the US market due to a request from the manufacturer or a request by the FDA due to public health concerns.
the Consumer Healthcare Products Association (CHPA) — a trade group representing makers of over-the-counter (OTC) drugs, dietary supplements and consumer medical devices — said it was “disappointed” by the committee’s vote.
“We urge the FDA, before making any regulatory determination, to consider the overall evidence supporting this long-standing OTC ingredient, as well as the negative unintended consequences associated with any potential change in oral PE’s regulatory status,” CHPA President. and CEO Scott Melville said in a statement.
