Adapting to the FDA's Phenylephrine Status Change in OTC Cold and Congestion Medications

The realm of OTC medications, often considered a quick and accessible remedy for common ailments, is currently undergoing a transformative phase. The catalyst for this change is the revised status of phenylephrine, a key ingredient in numerous OTC cold and congestion medications, as mandated by the FDA.¹

Phenylephrine, a nasal decongestant, has long been used to alleviate nasal congestion in various OTC formulations. Its mechanism involves narrowing blood vessels in the nasal passages, effectively reducing swelling and facilitating easier breathing.² Widely used and believed to be safe and effective, phenylephrine has been a staple ingredient in many cold and congestion medications available without a prescription. However, only 38% of the phenylephrine dose is bioavailable after ingestion, resulting in insufficient concentration to reach systemic circulation, and hence ineffective when taken orally.^3-5

Randy Hatton, PharmD, and Leslie Hendeles, PharmD, faculty at the University of Florida College of Pharmacy, have long been advocating for phenylephrine removal from the market.^6-9 In response to emerging concerns about the effectiveness of phenylephrine in oral formulations, the FDA has revisited its stance on including this ingredient in OTC medications. The regulatory body has called for more substantial evidence supporting the efficacy of phenylephrine when taken orally, prompting a reevaluation of its status.¹

Image credit: bnenin | stock.adobe.com

Pharmacists as Guides

Pharmacists play a pivotal role in guiding patients through this transition.¹⁰ With the change in FDA phenylephrine status, pharmacists must stay abreast of the evolving landscape of OTC medications. Their expertise is crucial in educating patients about regulatory changes, helping them navigate alternative formulations, and providing insights into evidence-based choices.¹¹

Educational Role

Pharmacists must take on an educational role, ensuring patients are informed about the shift in FDA phenylephrine status. Clear communication about the importance of evidence-based medicine and the FDA's commitment to consumer safety is paramount. Pharmacists can provide consumers alternative options to oral phenylephrine. Phenylephrine delivered nasally is proven effective in relieving congestion,¹² and available OTC nasal products include oxymetazoline, fluticasone, and azelastine. If the consumer prefers the oral option, they can always consider oral pseudoephedrine (Sudafed). Pharmacists need to be vigilant when evaluating pseudoephedrine and ask additional questions to ensure the patients do not have heart issues, because pseudoephedrine's vasoconstriction property is systemic and may increase blood pressure.¹³

Additionally, pharmacists are pivotal in educating consumers about the importance of informed decision-making when selecting OTC medications. Consumers must be aware that certain products exclusively contain phenylephrine, while others combine phenylephrine with one or more additional active ingredient(s), such as acetaminophen, ibuprofen, diphenhydramine, dextromethorphan, and/or guaifenesin. These additional ingredients target symptoms beyond congestion, such as headaches or muscle aches, cough, and fever. Importantly, the presence of phenylephrine in these combination products does not impact the effectiveness of the other active ingredients in addressing their respective symptoms. Noting that different drug products may be marketed under the same brand name, consumers should read the drug facts label when making selections to determine products' ingredients, warnings, and instructions for use.

Product Knowledge

Staying informed about specific products affected by this change is crucial. Pharmacists must be well-versed in new formulations and alternative ingredients that comply with the revised FDA guidelines.

Collaboration with Health Care Providers

Engaging in open communication with other health care providers is becoming increasingly essential for pharmacists. This communication ensures a cohesive approach to patient care, and pharmacists can guide suitable alternatives for OTC cold and congestion medications based on a patient’s individual needs.

Outlook for Cold and Congestion Medications

Major retail pharmacies such as CVS are voluntarily removing some of the most common cough and cold medicines from their store shelves and will no longer sell them after the FDA's announcement.¹⁴ The shifting landscape of OTC cold and congestion medications is not just a consequence of regulatory change; it represents an opportunity for innovation within the pharmaceutical industry. Pharmacists and consumers can anticipate several key developments as manufacturers respond to the new FDA guidelines.

1. Formulation Changes: The FDA has not decided whether to ask manufacturers and retailers to remove products containing phenylephrine; however, the pharmaceutical industry is likely to reformulate existing products or introduce entirely new formulations that adhere to the updated standards set by the FDA. This can lead to OTC medications that are not only effective but also backed by rigorous scientific evidence.
2. Innovation and Research: The evolving regulatory landscape creates a space for increased research and development efforts. Manufacturers may explore alternative ingredients with proven efficacy in managing cold and congestion symptoms. Industry may invest in exploring innovative solutions, combination therapies, or alternative approaches to ensure the continued efficacy of OTC cold and congestion medications.
3. Patient-Centric Approach: The emphasis on evidence-based medicine aligns with a broader movement toward patient-centered care. Patients can actively participate in their health care decisions with more straightforward information and effective medications, fostering a sense of empowerment and trust.

The change in FDA phenylephrine status marks a significant juncture in the evolution of OTC cold and congestion medications. It demands adaptability from health care professionals, particularly pharmacists, who guide patients through this transition. As the pharmaceutical landscape responds with innovation and evidence-based solutions, consumers can anticipate a new era of OTC medications that more effectively manage symptoms and instill confidence in their safety and efficacy. The journey ahead involves collaboration, education, and a commitment to providing patients with the best options for managing common cold and congestion symptoms.

References

1. FDA Drug Safety and Availability. FDA clarifies results of recent advisory committee meeting on oral phenylephrine. FDA. Published online September 14, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-results-recent-advisory-committee-meeting-oral-phenylephrine

2. Richards E, Lopez MJ, Maani CV. Phenylephrine. [Updated 2023 Oct 30]. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK534801/

3. Tanne JH. Phenylephrine: Commonly used decongestant in cold and flu remedies doesn't work, says FDA. BMJ. 2023;382:2124. Published 2023 Sep 18. doi:10.1136/bmj.p2124

4. Hatton RC, Winterstein AG, McKelvey RP, Shuster J, Hendeles L. Efficacy and safety of oral phenylephrine: systematic review and meta-analysis. Ann Pharmacother. 2007;41(3):381-390. doi:10.1345/aph.1H679

5. Kanfer I, Dowse R, Vuma V. Pharmacokinetics of oral decongestants. Pharmacotherapy. 1993;13(6 Pt 2):116S-146S.

6. Hatton RC, Winterstein AG, McKelvey RP, Shuster J, Hendeles L. Efficacy and safety of oral phenylephrine: systematic review and meta-analysis. Ann Pharmacother. 2007;41(3):381-390. doi:10.1345/aph.1H679

7. Hatton RC, Hendeles L. Over-the-Counter Oral Phenylephrine: A Placebo for Nasal Congestion. J Allergy Clin Immunol Pract. 2015;3(5):709-710. doi:10.1016/j.jaip.2015.06.014

8. Hendeles L, Hatton RC. Oral phenylephrine: an ineffective replacement for pseudoephedrine?. J Allergy Clin Immunol. 2006;118(1):279-280. doi:10.1016/j.jaci.2006.03.002

9. Hatton RC, Hendeles L. Why Is Oral Phenylephrine on the Market After Compelling Evidence of Its Ineffectiveness as a Decongestant? [published online ahead of print, 2022 Mar 25]. Ann Pharmacother. 2022;10600280221081526. doi:10.1177/10600280221081526

10. Ravichandran A, Basavareddy A. Perception of pharmacists regarding over-the-counter medication: A survey. Indian J Pharmacol. 2016;48(6):729-732. doi:10.4103/0253-7613.194857

11. Sinha HK. Role of pharmacists in retailing of drugs. J Adv Pharm Technol Res. 2014;5(3):107. doi:10.4103/2231-4040.137383

12. Gelotte CK, Parasrampuria DA, Zimmerman BA. Single-Dose Pharmacokinetics and Metabolism of the Oral Decongestant Phenylephrine HCl in Children and Adolescents. Pulm Ther. 2023;9(1):139-150. doi:10.1007/s41030-022-00206-8

13. Salerno SM, Jackson JL, Berbano EP. Effect of oral pseudoephedrine on blood pressure and heart rate: a meta-analysis. Arch Intern Med. 2005;165(15):1686-1694. doi:10.1001/archinte.165.15.1686

14. Murphy T. CVS Health pulls some cough-and-cold treatments with ingredient deemed ineffective by doctors. Associated Press. Updated October 20, 2023. Accessed January 8, 2024. https://apnews.com/article/cvs-health-cold-medications-phenylephrine-c8953a17b8e404cfe9e4a37d76993dc4