This post was written by Michael Hedrich, PharmD Candidate, Parkview Health.
You might have been hearing a lot about phenylephrine in the news lately. Recently, pharmacy lobbyists asked the Food and Drug Administration (FDA) to review evidence supporting the effectiveness of the popular oral decongestant ingredient.
Since 2006, when products containing pseudoephedrine were required to be placed behind pharmacy counters, phenylephrine has been the main decongestant ingredient in over-the-counter cold medicines. In 2022 alone, there were 242 million products sold for cough, cold and allergy symptoms containing phenylephrine. When first reviewed by the FDA in 1976, phenylephrine was considered to have GRAS/E status on the market, meaning it was “generally recognized as safe and effective.”
FDA findings
In September 2023, the FDA held an advisory committee meeting to determine if there was a safety or efficacy concern with phenylephrine or products containing phenylephrine. Scientists presented studies done in the past 20 years, with no evidence to support the efficacy of phenylephrine when compared to taking a placebo. As a result, the FDA advisory committee determined in a 16-0 vote that the medication is not effective. This change in position from the FDA represents increasing standards for research in the modern era of pharmacy.
It's important to note that while the evidence does not show a proven benefit, there is no inherent risk of harm in taking the medication.
The future of phenylephrine
As of right now, products containing phenylephrine are still available. However, the next step the FDA may take would be to look for possible reasons to take the drug off the market. The process for this will likely consist of a public comment period and the review of any additional information available to justify removing products from pharmacy shelves. If the FDA decides to remove phenylephrine’s GRAS/E status, then products containing the drug will have to be removed from stores. Some retail pharmacies have already begun to eliminate or reduce phenylephrine-containing products going into this cold and flu season.
How to treat cold, flu and allergy symptoms
Given all this news, it will be more important than ever to talk with your pharmacist when considering choices for cough and cold products this year. Combination or multi-symptom products containing phenylephrine also contain other ingredients known to be both safe and effective, so those may remain a reasonable choice at times.
If you find yourself seeking relief from nasal congestion this cold and flu season, you might want to consider phenylephrine alternatives such as:
Oxymetolazine nasal spray (such as Afrin® nasal spray)
- Not recommended for those less than six years old.
- Possibility of rebound congestion if used for more than three days at a time.
Pseudoephedrine tablets (such as Sudafed®)
- Not recommended for those less than 12 years old or adults with high blood pressure.
Phenylephrine nasal spray (such as Neo-Synephrine® nasal spray)
- Different route and more specific site of action that is different from oral PE.
- Not recommended for those less than four years old and adults with high blood pressure.
If you have questions about symptoms and medication treatment options, your pharmacist would be happy to help. You can information about Parkview’s outpatient pharmacy locations and hours here.
