FDA Panel Finds Sudafed, Benadryl And Most Decongestants With Phenylephine Don’t Work

The leading decongestants used by millions of Americans looking for relief from a stuffy nose is likely no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient.

Advisers to the Food and Drug Administration voted unanimously Tuesday (Sept. 12) against the effectiveness of the ingredient found in popular versions of Sudafed, Dayquil, and other medications sold on pharmacy shelves.

“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” said Dr. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine.

The FDA assembled its outside advisers to take another look at phenylephrine, which became the primary drug in over-the-counter decongestants when medicines with an older ingredient – pseudoephedrine – were moved behind pharmacy counters. A 2006 law forced the move because pseudoephedrine can be illegally processed into methamphetamine.

Those original versions of Sudafed and other medicines remain available without a prescription but account for about one-fifth of the $2.2 billion market for oral decongestants. Phenylephrine versions — sometimes labeled “PE” on the packaging — comprise the rest.

If the FDA follows through on the panel’s recommendations, Johnson & Johnson, Bayer, and other drugmakers could be required to pull their oral medications containing phenylephrine from store shelves. That would likely force consumers to switch to the behind-the-counter versions of the pills or to nasal sprays and drops that contain phenylephrine, which are not under review.

This week’s two-day meeting was prompted by researchers at the University of Florida, who petitioned the FDA to remove phenylephrine products based on recent studies showing they failed to outperform placebo pills in patients with cold and allergy congestion. The same researchers also challenged the drug’s effectiveness in 2007, but the FDA allowed the products to remain on the market pending additional research.

This time, the 16 members of the FDA panel unanimously agreed that current evidence doesn’t show a benefit for the drug.

“I feel this drug in this oral dose should have been removed from the market a long time ago,” said Jennifer Schwartzott, the patient representative on the panel. “Patients require and deserve medications that treat their symptoms safely and effectively, and I don’t believe that this medication does that.”

The advisers backed the conclusions of an FDA scientific review published before this week’s meeting, which found numerous flaws with the 1960s and 1970s studies initially used to support phenylephrine’s approval. Regulators said the studies were “extremely small” and used statistical and research techniques no longer accepted by the agency.

“The bottom line is that none of the original studies stand up to modern study design or conduct standards,” said Dr. Peter Starke, the agency’s lead medical reviewer.

Additionally, three larger, rigorously conducted studies published since 2016 showed no difference between phenylephrine medications and placebos for relieving congestion. Those studies were conducted by Merck and Johnson & Johnson and enrolled hundreds of patients.

A trade group representing nonprescription drugmakers, the Consumer Healthcare Products Association, argued that the new studies had limitations and that consumers should continue to have “easy access” to phenylephrine.

Like many other over-the-counter ingredients, phenylephrine was grandfathered into use during a sweeping FDA review in 1972. It has been sold in various forms for over 75 years, predating the agency’s regulations on drug effectiveness.

“Any time a product has been on the market that long, it’s human nature to make assumptions about what we think we know about the product,” said Dr. Theresa Michele, who leads the FDA’s Office of Nonprescription Drugs.

But FDA reviewers said their latest assessment reflects new testing insights into how quickly phenylephrine is metabolized when taken by mouth, leaving only trace levels that reach nasal passages to relieve congestion. The drug appears more effective when applied directly to the nose in sprays and drops.

There’s unlikely to be any immediate impact from Tuesday’s panel vote, which is not binding. The group’s negative opinion allows the FDA to pull phenylephrine from a federal list of decongestants deemed effective for over-the-counter pills and liquids. The FDA said removing the products would eliminate “unnecessary costs and delay in taking a drug that has no benefit.”

The FDA’s nasal decongestants drug list, or monograph, has not been updated since 1995. Changing a monograph has traditionally taken years or decades, requiring multiple rounds of review and public comment. However, a 2020 law passed by Congress streamlines the process, which should allow the FDA to accelerate the publication of new standards, doses, and labeling for nonprescription ingredients.

This article originally appeared on USA TODAY: Phenylephrine, the nasal decongestant in many cold medicines, found ineffective by FDA panel