CVS Announces Removal of Oral Phenylephrine Containing Products. Will Other Retail Pharmacies Follow?

In September 2023, the FDA held a Nonprescription Drug Advisory Committee meeting to discuss the effectiveness of oral phenylephrine as an active ingredient in OTC cough and cold products. The FDA press release indicated, “The committee discussed new data on the effectiveness of oral phenylephrine and concluded that the current scientific data do not support that the recommended dosage of orally administered phenylephrine is effective as a nasal decongestant. However, neither the FDA nor the committee raised concerns about safety issues with the use of oral phenylephrine at the recommended dose. Advisory committees provide independent advice and recommendations to FDA, but the agency makes the final decision. FDA will consider the input of this advisory committee and the evidence before taking any action on the status of oral phenylephrine.”¹ More information can be found on the FDA website.

In a news story released in October 2023, CVS Health announced that its company was voluntarily removing some of the most purchased OTC cold and cough medications from its stores. The news story reported, “We are aware of the FDA Advisory Committee's position on oral phenylephrine (PE) and will follow direction from the FDA to ensure products we sell comply with all laws and regulations," CVS Health said in a statement. "We are removing certain oral cough and cold products that contain phenylephrine as the only active ingredient from CVS Pharmacy stores. Other oral cough and cold products will continue to be offered to meet consumer needs."²

Sources indicate, “Retail stores in the U.S. sold 242 million bottles of drugs containing phenylephrine last year, up 30% from 2021, according to data compiled by FDA staff. Those bottles generated $1.8 billion in sales last year.”²

It is important to note that currently, the FDA has not established if their agency will ask drug manufacturers and retailers such as CVS to remove oral phenylephrine products.

Conclusion

The impact of removing oral phenylephrine-containing products off CVS shelves remains to be seen, and fortunately, there are some alternatives for managing congestion. While many individuals elect to use OTC decongestant products to treat nasal congestion, many patient populations should not use decongestants due to contraindications with certain medical conditions or due to drug/drug interactions with other medications. In addition to assisting patients dealing with nasal congestion from allergies, pharmacists are also well poised to identify patients experiencing nonallergic rhinitis due to using certain pharmacological agents and make clinical recommendations according to patient needs when feasible to address the underlying causes of congestion. When appropriate and no contraindications are present, patients who use decongestants to treat and manage nasal congestion can still obtain products that contain pseudoephedrine from behind the pharmacy counter and use the nasal sprays or inhaler products that contain decongestants that are delivered via nasal inhalation. There is also a host of non-pharmacological measures that patients can employ for the relief of nasal congestion, such as saline nasal spray, non-medicated inhalers that contain menthol, humidifiers or vaporizers, steam inhalation, vapor patches, aromatherapy using essential oils such as peppermint and eucalyptus and drug-free nasal strips.

References:

1. US Food and Drug Administration. FDA clarifies results of recent advisory committee meeting on oral phenylephrine. www.FDA.gov. Published September 14, 2023. Accessed November 8, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-results-recent-advisory-committee-meeting-oral-phenylephrine
2. CNBC. CVS to pull certain cold medicines containing decongestant phenylephrine from store shelves. www.cnbc.com. October 20, 2023. Accessed November 8, 2023. https://www.cnbc.com/2023/10/19/cvs-to-pull-certain-cold-medicines-from-store-shelves.html