• Posted November 7, 2024

FDA Proposes Ban on a 'Useless' Decongestant, Phenylephrine

More than a year after its advisory panel unanimously declared the drug phenylephrine to be useless against nasal congestion, the U.S. Food and Drug Administration is proposing that it be removed from common over-the-counter decongestants.

Products that include phenylephrine as an active ingredient include Sudafed PE, Vicks Sinex and Benadryl Allergy Plus Congestion.

In fact, "it is important to note that some products only contain oral phenylephrine as a single, active ingredient," the FDA said in a statement released Thursday.

However, based on the available science, it's time for consumers to stop throwing their money away on such products, the FDA said.

"It is the FDA's role to ensure that drugs are safe and effective," Dr. Patrizia Cavazzoni, who directs the FDA's Center for Drug Evaluation and Research (CDER), said in the statement. "Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”

The agency said its experts pored over decades of data on whether or not phenylephrine could ease nasal congestion. They found no evidence to support the claim, nor any evidence to support the notion that phenylephrine might boost the effects of other medicines included in a decongestant, such as acetaminophen or dextromethorphan.

At this point, the FDA's move remains a proposal only; the agency will accept comments on it until May 7, after which time the agency may move to a final order to remove phenylephrine from store shelves.

Right now, the FDA's proposal is only related to phenylephrine taken as a pill or syrup, not the nasal spray form.

Speaking at the time of the FDA advisory panel's vote, Jennifer Schwartzott, the patient representative on the panel, told that Associated Press that “I feel this drug in this oral dose should have been removed from the market a long time ago. Patients require and deserve medications that treat their symptoms safely and effectively, and I don’t believe that this medication does that.”

Medications with phenylephrine took on more prominence after the highly effective decongestant pseudoephedrine became harder to purchase in 2005, as part of legislation aimed at combatting the meth epidemic.

More than 242 million bottles or packages of phenylephrine-containing cold remedies were sold in 2022, compared with about 51 million cold products containing pseudoephedrine, FDA briefing documents for the meeting show.

“We believe that these new clinical pharmacology and clinical data are consistent, substantial and believable, and they confirm that orally administered phenylephrine is not effective at any dose that can be developed and still provide a reasonable margin of safety,” the documents said.

This prompted the FDA to review the studies that had been used to approve phenylephrine.

“We noted significant methodological and statistical issues with the design and conduct of the original studies submitted to and evaluated by the panel,” the documents stated.

The problem appears to be that the body doesn’t absorb phenylephrine well enough to make it useful. Higher doses might work, but those doses would cause blood pressure to spike significantly.

“Therefore, in addition to lack of efficacy, there may be no path to evaluating higher doses of oral phenylephrine as a nasal decongestant,” the FDA concluded.

An industry group, the Consumer Healthcare Products Association (CHPA), argued against the FDA’s position before the agency’s panel last year.

“Considering the data from multiple clinical trials demonstrating effectiveness and decades of in-market experience, CHPA urges the panel to recognize phenylephrine’s clear benefits and critical role in public health,” CHPA Vice President of Regulatory & Scientific Affairs Marcia Howard said in a statement to the committee.

The CHPA also asked the panel to consider the potential impact on consumers.

“Simply put, the burdens created from decreased choice and availability of these products would be placed directly onto consumers and an already-strained U.S. health care system, which is why CHPA encourages the panel to consider the real-world experience and needs of consumers when making decisions that will have such broad implications,” Howard added.

But in its statement issued Thursday, the FDA said consumers do have alternatives to phenylephrine when noses get stuffy.

"Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold," Dr. Theresa Michele, director of the Office of Nonprescription Drug Products at CDER. "Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms.”

More information

Find out more about beating cold symptoms at the Mayo Clinic.

SOURCES: U.S. Food and Drug Administration, statement, Nov. 7, 2024; FDA Briefing Document: Efficacy of Oral Phenylephrine as a Nasal Decongestant, Sept. 11, 2023; Consumer Healthcare Products Association, statement, Sept. 11, 2023; Associated Press