FDA Recommends Removal of Oral Phenylephrine from OTC Cough and Cold Products

The FDA has proposed removing oral phenylephrine (found in products like Sudafed PE by Johnson & Johnson) from over-the-counter medications intended for temporary nasal congestion relief. This recommendation comes after the FDA’s thorough review concluded that oral phenylephrine does not effectively alleviate nasal congestion.

“It is the FDA’s duty to ensure that medications are both safe and effective,” stated Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER). “Based on available data and following the advisory committee’s guidance, we are moving forward with proposing the removal of oral phenylephrine, as it does not effectively serve as a nasal decongestant.”

Phenylephrine, commonly included in OTC allergy and cold remedies to help relieve congestion by reducing blood vessel inflammation in the nasal passages, is a component of widely recognized medications such as NyQuil, Benadryl, Sudafed, and Mucinex. While some of these products list phenylephrine as the sole active ingredient, others combine it with additional active compounds. The FDA clarified that phenylephrine’s removal would not impact the effectiveness of other active ingredients within these formulations. This proposal pertains strictly to the ineffectiveness of oral phenylephrine, not to concerns over safety, allowing continued marketing of the products in question.

In September 2023, the FDA convened a Nonprescription Drug Advisory Committee to reassess oral phenylephrine’s status as “Generally Recognized as Safe and Effective” (GRASE) for nasal congestion. This discussion stemmed from a University of Florida researchers’ petition, presenting evidence that oral phenylephrine, even at higher doses, is ineffective. Scientific data indicate that only minimal amounts of the drug reach nasal tissues.

If implemented, removing oral phenylephrine from OTC products could financially impact retailers like CVS and Walgreens, which sold 242 million bottles of phenylephrine-based medications in 2022, generating approximately $1.8 billion. Some consumers may also be affected, as survey data from the Consumer Healthcare Products Association suggest a general preference for oral decongestants over nasal sprays.

“Consumers should be aware that many safe and effective options exist to temporarily relieve nasal congestion from allergies or colds,” noted Dr. Theresa Michele, director of the Office of Nonprescription Drug Products within CDER. “They can consult with their doctor or pharmacist for suitable symptom relief options.”
The FDA has opened a public comment period before making a final decision on the removal of OTC oral phenylephrine. If the proposal is finalized, manufacturers will be allotted time to either withdraw or reformulate products containing oral phenylephrine. In the meantime, consumers are encouraged to consider alternative treatments and consult healthcare providers or pharmacists for effective options.

Local Support from Mediserv Pharmacy in the Bronx, NY

At Mediserv Pharmacy in the Bronx, we prioritize providing our community with safe and effective healthcare products. As the FDA considers removing oral phenylephrine from over-the-counter cough and cold medications, our knowledgeable team at Mediserv Pharmacy is here to guide you through alternative options for nasal congestion relief. Our pharmacists are available to answer questions and help you find reliable solutions tailored to your health needs. Visit Mediserv Pharmacy, your trusted local pharmacy in Bronx, New York, for support and advice on maintaining respiratory comfort during cold and allergy seasons.

References

1. FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review. November 7, 2024. Accessed November 7, 2024. https://www.fda.gov/news-events/press-announcements/fda-proposes-ending-use-oral-phenylephrine-otc-monograph-nasal-decongestant-active-ingredient-after
2. CNBC. “FDA Proposes Ending Use of Decongestant Found in Many Cold, Allergy Medicines.” November 7, 2024. Accessed November 7, 2024. https://www.cnbc.com/2024/11/07/fda-decongestant-cold-medicines.html
3. CNBC. “Decongestant Found in Many Cold, Allergy Medicines Doesn’t Actually Work, FDA Advisors Say.” September 12, 2023. Accessed November 7, 2024. https://www.cnbc.com/2023/09/12/decongestant-phenylephrine-ineffective.html