Now, the FDA is requesting public comments as it tries to determine whether to remove phenylephrine from the market. A new study published as a research letter in JAMA describes patterns of purchasing of oral decongestants as a drug class, including phenylephrine and pseudoephedrine products; the latter had 13.2 billion units purchased, amounting to $3.8 billion in pharmacy expenditures.
“Phenylephrine and pseudoephedrine are the only oral formulations of nasal decongestants currently available in the US and are primarily sold over the counter (OTC),” wrote the University of Pittsburgh–led authors. “Concerns about ineffectiveness of oral phenylephrine have been raised since the 1990s.”
For the serial cross-sectional study, the research team used IQVIA’s Multinational Integrated Data Analysis quarterly pharmaceutical sales volume (units) data licensed from IQVIA for the U.S. for 2012 to 2021.
That database includes sales of pharmaceutical products purchased by retail outlets, including chain and independent pharmacies, mass merchandisers, food stores with pharmacies, and mail service pharmacies, as well as nonretail outlets. Purchased units are considered the smallest unit of consumption (e.g., 1 tablet or 5 mL).
To focus on consumer products, this study examined all oral products containing phenylephrine or pseudoephedrine purchased by retail pharmacies and outlets, including OTC and prescription formulations.
Sales of oral decongestants were determined by calculating the annual number of purchased units of phenylephrine- and pseudoephedrine-containing products. Annual inflation-adjusted prerebate pharmacy expenditures were calculated for each product with the Consumer Price Index for All Urban Consumers.
During the study period, 732 unique phenylephrine products (21 stand-alone, 711 combination products) and 495 pseudoephedrine products (54 stand-alone, 441 combination products) were on the market.
“Units of phenylephrine purchased outpaced pseudoephedrine in all years. There was no significant monotonic trend (P = .11) in phenylephrine sales; pseudoephedrine sales declined significantly from 1.68 billion units in 2012 to 0.98 billion units in 2021 (P <.001),” the study pointed out.
By 2021, 47 unique phenylephrine-containing formulations and 32 pseudoephedrine-containing formulations were available. “For sales of phenylephrine-containing formulations, 85.5% contained three or more active ingredients, most commonly analgesics and antitussives, compared with 15.8% of pseudoephedrine-containing formulations,” the researchers noted.
“Despite a lack of clinical efficacy evidence, phenylephrine was the most common oral decongestant in the U.S. from 2012-2021, with hundreds of millions of units purchased by retail pharmacies annually, and sales remained stable during this time,” the authors explained. “In contrast to pseudoephedrine, which is often formulated as a stand-alone product, most phenylephrine products were coformulated with antihistamines or antitussives, which are likely to provide some symptom relief for cough and cold symptoms.”
The article points out that the 2020 Coronavirus Aid, Relief, and Economic Security Act revised the regulatory process for nonprescription drugs, providing a mechanism to administratively remove drugs no longer deemed effective. “If the FDA follows its advisory board recommendation and issues a proposed order to remove oral phenylephrine from its ‘OTC monograph,’ reformulation of all phenylephrine-containing products would be required, which could have ramifications for supply chains,” the researchers wrote.
“During the time required for reformulation and introduction of new products, clinicians and consumers could consider oral pseudoephedrine or intranasal decongestants, including phenylephrine or oxymetazoline, as alternatives.”
The study added that delays between concerns about the efficacy of oral phenylephrine being raised and FDA action “highlight the need for continued reform of the nonprescription drug review process, such as expanding the capacity of the FDA Office of Nonprescription Drugs and investing in data infrastructure to allow timelier post market evaluations.”
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