FDA panel votes against phenylephrine, a common decongestant drug in many cold medicines

Phenylephrine, Decongestant, FDA, cold medicine, Sudafed, Dayquil, OTC drug Image: pharmacies

For decades, the shelves of American pharmacies have been stocked with hundreds of oral decongestant products containing phenylephrine, promising relief from cold and flu symptoms. However, a pivotal moment arrived this Tuesday when an FDA advisory committee, in a unanimous 16-0 vote, declared that this ingredient simply doesn’t deliver on its promises.

Now, the ball is in the FDA’s court as they weigh the decision of potentially banning the over-the-counter use of widely popular cold and flu remedies, including household names like Sudafed, Nyquil, Benadryl, Mucinex, and Tylenol, all of which contain phenylephrine. In 2022 alone, these products, totaling approximately 250 different medications, raked in a staggering $1.8 billion in sales.

The basis for this resounding rejection stems from comprehensive data presented during a two-day committee review. The evidence revealed that phenylephrine, when administered orally, performed no better than a placebo in alleviating congestion. Phenylephrine is designed to reduce the swelling of blood vessels, but the committee concluded that when taken by mouth, insufficient amounts of the drug actually reach the nasal passages.

Maria Coyle, chairwoman of the Nonprescription Drugs Advisory Committee (NDAC) and a respected professor of pharmacy at Ohio State University, articulated the committee’s stance succinctly during the deliberations: “We clearly have better options in the over-the-counter space to help our patients, and the studies do not support that this is an effective drug.”

Interestingly, while oral phenylephrine is under scrutiny, nasal sprays containing the compound remain effective. Furthermore, phenylephrine has proven its worth in dilating the eyes and as an essential tool during surgical procedures.

“The burdens created from decreased choice and availability of these products would be placed directly onto consumers and an already-strained US healthcare system. The CHPA encourages the panel to consider the real-world experience and needs of consumers when making decisions that will have such broad implications.”

– Consumer Healthcare Products Association

Should the FDA decide to revoke phenylephrine’s over-the-counter designation, it could spell significant disruption. Pharmacies would need to clear their shelves of medications containing the ingredient, and companies would be compelled to reformulate many of their beloved cold and flu products.

Phenylephrine is one of just two oral decongestants available without a prescription. The other, pseudoephedrine, faced restrictions in 2006 due to its potential misuse in the production of methamphetamine. While products with pseudoephedrine are still available over the counter, they are often kept behind store counters or securely locked away, out of the immediate reach of consumers. There are also limitations on the quantity of pills that can be purchased during a single store visit.

This regulatory shift led to a surge in products containing phenylephrine. However, not long after their rise to prominence, the FDA began scrutinizing phenylephrine closely. In 2007, the NDAC arrived at a similar conclusion regarding its ineffectiveness. Although subsequent studies confirmed phenylephrine’s ineffectiveness when taken in pill form, there remained some variability in the results, prompting questions about the rigor of these studies.

“We do believe that the original studies were methodologically unsound and do not match today’s standard. By contrast, we believe the new data are credible and do not provide evidence that oral phenylephrine is effective.” 

– Peter Starke, who first led the FDA’s review of phenylephrine

In a twist that could reshape the cold and flu remedy landscape, the FDA’s final decision looms, poised to impact not only the pharmaceutical industry but the countless consumers seeking relief from congestion and discomfort during flu season. Stay tuned for the FDA’s verdict on the fate of phenylephrine and the potential transformation of your go-to over-the-counter remedies.

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