FDA Experts Warn Top Over-The-Counter Drug Ineffective

The top over-the-counter decongestant used by numerous Americans may be no more effective than a placebo, as indicated by specialists who have assessed the recent studies on this widely used drug component.

The Food and Drug Administration’s advisory board voted on Tuesday, challenging the ingredient’s efficacy in commonly used medications such as Sudafed, Allegra, Dayquil, and many more available at pharmacies.

“Recent, rigorously conducted studies do not demonstrate any notable congestion relief with phenylephrine,” remarked Dr. Mark Dykewicz, an allergy expert from the Saint Louis University School of Medicine.

The FDA convened its panel to reexamine phenylephrine, which became the primary ingredient in over-the-counter decongestants after medications containing pseudoephedrine were relocated behind pharmacy counters due to concerns about illegal methamphetamine production.

Although the original formulations of Sudafed and similar medicines are still available without prescriptions, they comprise approximately 20 percent of the $2.2 billion oral decongestant market. The rest is dominated by phenylephrine products, often indicated by “PE” on the packaging.

If the FDA adheres to the advisory board’s suggestions, pharmaceutical companies like Johnson & Johnson and Bayer might need to withdraw their oral phenylephrine-based products. This new information could direct consumers to opt for the behind-the-counter versions or nasal products containing phenylephrine, which aren’t currently being scrutinized.

A request from University of Florida researchers sparked the FDA’s reconsideration. Their findings, which suggested phenylephrine products didn’t outdo placebo pills in treating cold and allergy symptoms, challenged the drug’s efficacy. Although the same concerns were raised in 2007, further research was awaited.

The recent unanimous agreement among the 16-member FDA panel indicated that the current data doesn’t favor the drug. Jennifer Schwartzott, a panel member, stated, “This drug should’ve been withdrawn from the market long ago. Patients need effective remedies, and I don’t believe this drug provides that.”

The panel’s findings are consistent with a pre-meeting FDA scientific assessment, which highlighted issues with studies from the 1960s and 1970s that initially supported phenylephrine. The agency criticized these studies for being outdated and not meeting current research standards.

Moreover, three substantial studies from 2016 onwards, conducted by Merck and Johnson & Johnson, found no significant difference in congestion relief between phenylephrine and placebo.

However, the Consumer Healthcare Products Association, a representative of nonprescription drug manufacturers, believes there are flaws in the newer studies and advocates for continued easy access to phenylephrine.

Phenylephrine’s use in over-the-counter products dates to a time when many such ingredients were readily accepted without the rigorous scrutiny of today.