Common oral decongestant phenylephrine found ineffective for nasal relief

The U.S. Food and Drug Administration (FDA) has proposed removing phenylephrine, a common oral decongestant in over-the-counter cold and flu medications, from the market due to its ineffectiveness in relieving nasal congestion. The move follows a unanimous vote by an FDA advisory panel in 2023, which concluded that oral phenylephrine performs no better than a placebo for this purpose. The decision has sparked a broader conversation about the regulation of over-the-counter (OTC) medications and the need for evidence-based efficacy standards.

FDA Proposes Removing Ineffective Decongestant from Over-the-Counter Market

On November 7, 2024, the FDA proposed revoking the approval of phenylephrine as an oral decongestant in OTC cold and flu remedies, citing a lack of evidence for its effectiveness. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, stated, “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 advisory panel’s findings were based on recent studies showing that oral phenylephrine is largely inactive when ingested. “It basically becomes deactivated before it enters your bloodstream,” said Stefanie Ferreri, a pharmacy professor at the University of North Carolina. “It’s almost like a placebo, a sugar pill, when it’s taken orally.” Despite this, phenylephrine remains effective when administered as a nasal spray, though such products are less commonly used.

Historical Context: Pseudoephedrine to Phenylephrine

Phenylephrine’s rise as a decongestant in OTC products was driven by concerns over its predecessor, pseudoephedrine. Between 1996 and 2005, the drug was linked to the illicit production of methamphetamine, prompting stricter regulations. In 2006, pseudoephedrine was reclassified as a “pharmacist-only” product in the U.S., making it harder to obtain. To maintain product availability, manufacturers replaced pseudoephedrine with phenylephrine, which was less likely to be misused.

However, the shift was not based on clinical superiority. “Phenylephrine was never a better medicine—it was a safer option in terms of misuse,” said Aaron Kesselheim, a Harvard Medical School professor. Early studies suggested it was effective, but subsequent research revealed its limitations. “It’s a very old product, so old that it did so without the sort of evidence we would expect today from new drug approvals,” Kesselheim noted.

Scientific Evidence Against Oral Phenylephrine

Research over the past two decades has consistently shown that oral phenylephrine fails to relieve nasal congestion. A 2023 FDA advisory committee review found that the drug is “not effective for nasal congestion when given at standard doses.” Studies indicate that when taken orally, phenylephrine is rapidly metabolized in the gut, preventing it from reaching the nasal passages in sufficient quantities to act as a decongestant.

Leslie Hendeles, a University of Florida professor who petitioned the FDA to reevaluate phenylephrine, argued that even higher doses would not resolve the issue. “Even doses 400% higher than those currently recommended don’t treat stuffiness,” he said. “Pushing the dosage further might carry safety risks, such as dangerously high blood pressure.”

Regulatory Process and Consumer Impact

The FDA’s proposal marks the first step in a lengthy regulatory process. The agency must now accept public comments for six months before finalizing its decision. Manufacturers may also request additional hearings, potentially delaying the change for years. “Our position is that choosing from something that doesn’t work isn’t really a choice,” Hendeles said.

Meanwhile, the Consumer Healthcare Products Association (CHPA) has urged the FDA to reconsider, arguing that removing phenylephrine could limit consumer access to affordable treatments. “The burdens created from decreased choice and availability of these products would be placed directly onto consumers,” said CHPA’s Marcia Howard.

For consumers, the news highlights the importance of reading labels and consulting healthcare providers. “If you’ve used something and you felt like it was helpful, I don’t think there’s a problem with that,” said Dr. Lauren Eggert of Stanford University. “There’s little harm for people who are looking for relief. And I do believe in the placebo effect.”

Alternatives and Recommendations for Consumers

Doctors recommend alternatives for nasal congestion, including nasal sprays containing oxymetazoline or xylometazoline, which are effective for short-term use. Saline rinses and steam inhalation are also safe, non-pharmacological options. For long-term allergy management, nasal steroids like fluticasone (Flonase) are considered the most effective.

Consumers seeking oral decongestants may still find pseudoephedrine products behind the counter, though they require identification. “The biggest issue is they’re not great when used on an as-needed basis,” said Dr. Brian Schroer of the Cleveland Clinic. “They have to be used daily to be highly effective.”

Despite the FDA’s proposal, phenylephrine will remain on store shelves for the foreseeable future. “It’s a good drug, but not when it’s swallowed,” Hendeles said. “It’s inactivated in the gut and doesn’t get into the bloodstream, so it can’t get to the nose.”

Ongoing Debate Over Over-the-Counter Medicine Regulation

The phenylephrine controversy underscores broader concerns about the regulation of OTC medications. Many products on shelves today were grandfathered in under outdated monographs, with limited evidence of efficacy. “There are a lot of products being sold at your local pharmacy or grocery store that don’t have the same level of evidence behind them that we expect from prescription medications,” Kesselheim said.

The FDA’s decision may set a precedent for reevaluating other OTC drugs, such as cough suppressants and expectorants. “I know for sure that the cough suppressants and the expectorants are next in line,” Hendeles said. As the regulatory process unfolds, consumers are advised to stay informed and seek guidance from healthcare professionals to navigate the complex landscape of cold and flu remedies.