Removing Phenylephrine from Decongestants Could Reshape OTC Cold Treatments

In September 2023, the FDA’s Nonprescription Drug Advisory Committee concluded that current scientific data do not support the effectiveness of the oral decongestant phenylephrine.first This raises concerns about the effectiveness of some OTC cough and cold products that contain phenylephrine as the main active ingredient. While it is reassuring to note that neither the FDA nor the commission raised safety concerns about the recommended dosage of oral phenylephrine, the effectiveness of these products is important to people. Consumers are looking for ways to reduce congestion.

The process outlined to remove phenylephrine from the OTC monograph is a transparent and consumer-centric approach. By issuing the proposed order and allowing public comment, FDA ensures that public concerns and views are considered in any decision. Consumers should also be aware of the variety of alternative products available for temporary relief of nasal congestion. It is especially important that consumers read drug information labels to identify the ingredients in the product and understand any warnings or directions for use. This empowers consumers to make informed decisions about their health care and choose products that suit their specific needs. Finally, phenylephrine may be removed from oral cough and cold products in the near future, if the FDA deems it necessary.

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In 2020, oral phenylephrine accounted for an estimated 66,296 prescription orders for more than 15,000 patients.2 The average out-of-pocket cost to fulfill each of these orders is $18.51,2 creates a significant financial burden for consumers even when use is supervised by a physician. However, the main way to obtain oral phenylephrine is still to purchase OTC at direct cost to the person in need. The American Academy of Allergy, Asthma and Immunology has reported that phenylephrine is the most common active ingredient in OTC cough and cold products.3 (see table 1). Furthermore, the FDA estimates 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 to relieve nasal congestion, but recent data suggests their money would be better spent elsewhere.

There are several alternatives to oral phenylephrine for temporary relief of nasal congestion, both non-pharmacological and pharmacological. Before reaching for pharmacological options, consumers may consider taking a hot, steamy bath or wrapping a warm towel around their face to help relieve pain. Another potential option could be a neti-pot, which uses saline to rinse the nose instead of medication.6

Nasal congestion can be treated with decongestants, usually oxymetazoline nasal spray (Afrin; Bayer), 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 taking systemic decongestants due to the potential for worsening blood pressure. It is best to seek guidance from a healthcare provider and/or pharmacist when purchasing OTC decongestants to choose the most appropriate formulation to treat symptoms.

An alternative systemic decongestant to oral phenylephrine is pseudoephedrine; However, the use of this product may have significant limitations. Side effects include tachycardia, dizziness, insomnia, restlessness, and headache, all of which are more commonly reported with pseudoephedrine because it has higher oral bioavailability than 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 the requirement to purchase over-the-counter medication. The Methamphetamine Epidemic Act of 2005 requires retailers to keep pseudoephedrine behind the counter and limits the monthly quantity that an individual can purchase.7 This drug sales restriction may be a barrier to consumers purchasing this decongestant, as many consumers may not be familiar with this law. It is important to avoid the use of pseudoephedrine in certain patient groups, including those with a history of cardiovascular disease or those who are elderly, children, or pregnant, as this medication may be unsafe. all in these groups.7

There are also a number of nasal spray products that can be used to relieve nasal congestion (see table 2), which is the preferred route of administration because they act locally in the nose. Decongestants work by narrowing the blood vessels in the nose, reducing swelling and the feeling of nasal congestion, making it easier for you to breathe.7 Nasal decongestants are generally well tolerated, with most side effects being local reactions such as burning, stinging, and runny nose.7 However, nasal decongestants may be associated with congestion. blockage reaction, so use should be limited to a maximum of 3 days.7

The FDA’s recent announcement of the lack of effectiveness of the oral decongestant phenylephrine has raised significant concerns about the utility of many oral OTC products containing the active ingredient phenylephrine. While consumers should be aware of this recent discovery, they should also be aware of the range of alternative products, specifically decongestants, that are available to temporarily relieve nasal congestion. Based on recent findings, consumers are encouraged to make informed decisions regarding OTC medications and should always consult their healthcare provider and/or local pharmacist for advice. Buy the best product for them. Ultimately, the decision to eliminate phenylephrine as an active ingredient in oral cough and cold products could reshape the landscape of OTC treatments, potentially leading to more effective options. more in the future.

About the author

Katelyn Leary And Mason Shink is a 2024 PharmD candidate at Husson University School of Pharmacy.

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

Presenter

  1. US Food and Drug Administration. FDA clarifies results of recent advisory committee meeting on oral phenylephrine. US Food and Drug Administration. September 14, 2023. Accessed October 11, 2023.https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarify-results-recent-advisory-committee-meeting- Oral-phenylephrine
  2. Kane SP. Phenylephrine, ClinCalc Drug 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. Statement from the American Academy of Allergy, Asthma & Immunology and the American College of Allergy, Asthma & Immunology supporting the citizen petition to remove oral phenylephrine from non-status status. prescription. 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. U.S. Food and Drug Administration Nonprescription Drug Advisory Committee. Efficacy of oral phenylephrine as a decongestant: Nonprescription drug advisory committee meeting. US Food and Drug Administration. September 11, 2023. Accessed October 11, 2023. https://www.fda.gov/media/171915/download
  5. Medication information of AHFS patients. 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; Cough treatment table by CHEST experts. Pharmacological and nonpharmacological treatment of acute cough associated with the common cold: Report of the CHEST expert panel. Chest. 2017;152(5):1021-1037. doi:10.1016/j.chest.2017.08.009
  7. Scolaro KL. Chapter 11: Colds and allergies. IN: The Nonprescription Drug Handbook: An Interactive Approach to Self-Care. 20th edition American Pharmacists Association. December 2020.

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