Removal of Phenylephrine From Nasal Decongestants Could Reshape OTC Cold Remedies

In September 2023, the FDA Nonprescription Drug Advisory Committee concluded that current scientific data do not support the effectiveness of oral phenylephrine as a nasal decongestant.¹ This raises concerns regarding the efficacy of certain OTC cough and cold products that contain phenylephrine as a key active ingredient. Although it’s reassuring to note that neither the FDA nor the committee raised safety concerns about the recommended dosage of oral phenylephrine, the effectiveness of these products is crucial for consumers seeking relief from congestion.

The process outlined for the potential removal of phenylephrine from the OTC monograph is a transparent and consumer-centric approach. By issuing a proposed order and allowing public comments, the FDA ensures that the public’s concerns and perspectives are considered in any decision. Consumers should also be aware of the range of alternative products available for temporary relief of nasal congestion. It is especially important for consumers to read drug facts labels to determine the ingredients in a product and understand any warnings or directions for use. This empowers consumers to make informed decisions about their health care and choose the right product for their specific needs. Ultimately, phenylephrine could potentially be removed from oral cough and cold products in the near future, if the FDA deems necessary.

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In 2020, oral phenylephrine accounted for an estimated 66,296 prescription orders spanning more than 15,000 patients.² The average out-of-pocket cost to fill each of these orders was $18.51,² creating a significant financial burden for consumers even when use is overseen by a physician. However, the primary way to obtain oral phenylephrine remains through OTC purchasing at direct cost to the person in need. The American Academy of Allergy, Asthma and Immunology reported that phenylephrine is the most common active ingredient in OTC cough and cold products³ (see table 1).Furthermore, the FDA estimated that 242 million phenylephrine products were sold in the US in 2022, generating $1.76 billion in profits.⁴ Year after year, consumers turn to oral phenylephrine products for relief of nasal congestion, but the recent data suggest that their money would be better spent elsewhere.

There are several alternative options to oral phenylephrine for temporary relief of nasal congestion, both nonpharmacological and pharmacological. Before reaching for a pharmacological option, consumers might consider hot, steamy showers or a warm towel wrapped around their face to provide relief. Another potential option could be the neti-pot, which uses salt water to flush the nasal passages rather than medication.⁶

Nasal congestion may be treated with intranasal decongestants, commonly oxymetazoline (Afrin; Bayer) nasal spray or with an alternative systemic decongestant, pseudoephedrine (Sudafed; Johnson and Johnson).⁷

When choosing the right decongestant, it is important to evaluate any underlying medical conditions. For example, a person with hypertension should avoid systemic decongestants due to the potential of worsening blood pressure. It is best to seek the guidance of a health care provider and/or pharmacist when purchasing OTC decongestants in order to select the most appropriate formulation to target symptoms.

An alternative systemic decongestant to oral phenylephrine is pseudoephedrine; however, use of this product may come with significant drawbacks. Adverse effects include tachycardia, dizziness, insomnia, restlessness, and headache, all of which are more commonly reported with pseudoephedrine as it has a higher oral bioavailability when compared to phenylephrine.⁷ Pseudoephedrine can be taken every 4 to 6 hours as needed for symptom relief (see table 2), but another drawback to its use is its “behind-the-counter” purchasing requirement. The Combat Methamphetamine Epidemic Act of 2005 requires retailers to keep pseudoephedrine behind the pharmacy counter and limits the monthly amount individuals can purchase.⁷ This behind-the-counter limitation could be a barrier for consumers to purchase this decongestant, as many consumers may not be familiar with this law. Of note, it is also important avoid use of pseudoephedrine in certain patient populations, including those with a history of cardiovascular disease or those who may be elderly, pediatric, or pregnant, as this medication may not be safe in these populations.⁷

There are also several intranasal products that may be used to relieve nasal congestion (see table 2), which is the preferred route of administration as they act locally in the nose. Intranasal decongestants work by narrowing the blood vessels in the nose, which reduces the swelling and feelings of congestion, making it easier to breathe.⁷ Intranasal decongestants are usually well tolerated with most adverse effects being localized reactions such as burning, stinging, and nasal discharge.7 However, intranasal decongestants may be associated with rebound congestion, so it is recommended to limit duration of use for a maximum of 3 days.⁷

The recent FDA announcement about the lack of efficacy of oral phenylephrine as a nasal decongestant has raised significant concerns about the utility of numerous oral OTC products containing phenylephrine as an active ingredient. Although consumers should be aware of this recent finding, they also should be aware of the array of alternative products, namely intranasal decongestants, available for the temporary relief of nasal congestion. In light of the recent findings, consumers are encouraged to make informed decisions about OTC medications and should always consult their health care provider and/or local pharmacist to purchase the best product for them. Ultimately, the decision to remove phenylephrine as an active ingredient in oral cough and cold products may reshape the landscape of OTC remedies, potentially leading to more efficacious options in the future.

About the Authors

Katelyn Leary and Mason Shink are 2024 PharmD candidates at the Husson University School of Pharmacy.

Angela Hartsig, PharmD, BCACP, is assistant professor of pharmacy practice at the Husson University School of Pharmacy.

References

1. United States Food & Drug Administration. FDA clarifies results of recent advisory committee meeting on oral phenylephrine. U.S. Food & Drug Administration. September 14, 2023. Accessed October 11, 2023.https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-results-recent-advisory-committee-meeting-oral-phenylephrine
2. Kane SP. Phenylephrine, ClinCalc DrugStats Database, Version 2022.08. ClinCalc. August 24, 2022. Accessed October 11, 2023. https://clincalc.com/DrugStats/Drugs/Phenylephrine
3. Meltzer EO, Bernstein JA, Sublett JW. American Academy of Allergy, Asthma & Immunology’s and American College of Allergy, Asthma & Immunology’s statement of support of citizen’s petition for removal of oral phenylephrine from over-the-counter status. 2022. Accessed October 11, 2023. https://college.acaai.org/wp-content/uploads/2022/05/oral-phenylephrine-final-statement-in-support-of-citizens-petition-05-4-22.pdf
4. United States Food and Drug Administration Nonprescription Drug Advisory Committee. Efficacy of oral phenylephrine as a nasal decongestant: Nonprescription drug advisory committee meeting. U.S. Food and Drug Administration. September 11, 2023. Accessed October 11, 2023. https://www.fda.gov/media/171915/download
5. AHFS Patient Medication Information. Phenylephrine. American Society of Health-System Pharmacists. January 15, 2022. Accessed October 11, 2023. https://medlineplus.gov/druginfo/meds/a606008.html
6. Malesker MA, Callahan-Lyon P, Ireland B, Irwin RS; CHEST Expert Cough Panel.Pharmacologic and Nonpharmacologic Treatment for Acute Cough Associated With the Common Cold: CHEST Expert Panel Report. Chest. 2017;152(5):1021-1037. doi:10.1016/j.chest.2017.08.009
7. Scolaro KL. Chapter 11: Colds and allergy. In: Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. 20th ed. American Pharmacists Association. December 2020.