FDA Proposes Ban on a “Useless” Decongestant, Phenylephrine

THURSDAY, Nov. 7, 2024 (HealthDay News) — 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 poured 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 the 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 combating 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.