Oral phenylephrine vote may see OTC products pulled in US

cold and allergy oral meds
Brittany Colette

An FDA advisory committee has concluded that a commonly used decongestant ingredient used in cold and allergy products does not have any efficacy, raising the possibility that many over-the-counter products may be withdrawn from sale or reformulated.

In a unanimous vote, the panel concluded that oral formulations of phenylephrine – used in big-selling brands like Sudafed, Benadryl, and some Advil and Tylenol products, from companies including Haleon, Procter & Gamble, and Kenvue – are no more effective than placebo in relieving nasal congestion.

Data presented at the meeting by the FDA suggested that phenylephrine is the most common oral decongestant used in the US, found in around 250 products with sales of almost $1.8 billion last year.

If endorsed by the FDA – which would result in the OTC designation of the drug as "generally recognised as safe and effective" being revoked – the advisory committee's determination could leave manufacturers scrambling to reformulate their brands just ahead of the coming respiratory infection season, or withdrawing them from sale.

Crucially, the vote does not apply to phenylephrine delivered into the airways - for example, by nasal sprays - so, patients will have other options if that does happen. 

The panel was specifically looking at the oral bioavailability of the drug, which is thought to work by reducing swelling in the blood vessels of the nose. They concluded, however, that very little of the drug reaches the nose when taken in pill form, although there was no issue with the safety of the drug.

The Consumer Healthcare Products Association (CHPA) – which represents many of the manufacturers of these products – issued a statement which said it was disappointed by the outcome of the meeting because the panel's "non-binding recommendation is at odds with the numerous clinical trials and previous regulatory determinations affirming oral phenylephrine […] as a safe and effective decongestant at its labelled dose."

CHPA's president and chief executive, Scott Melville, asked that the FDA "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 [its] regulatory status" before making any regulatory decision.

Phenylephrine started to be used in OTC decongestants after manufacturers moved away from the use of pseudoephedrine and ephedrine due to FDA restrictions. Those ingredients are vulnerable to abuse due to their stimulant and euphoric properties and the potential to serve as a precursor for illicit production of other drugs like methamphetamine.

Former FDA Commissioner and industry expert Scott Gottlieb commented that restricting the use of the drug could mean that patients have fewer accessible options, driving up healthcare costs.

Photo by Brittany Colette on Unsplash.

13 September, 2023