Phenylephrine Sales Steady Before FDA Panel Called It Ineffective

Sales of the most commonly used over-the-counter (OTC) oral decongestant, which was deemed ineffective by FDA staff and advisors last year, remained steady through 2021, and researchers warn that pulling the drug could disrupt the supply chain.

In a cross-sectional study using data from 2012 to 2021, there were 19.8 billion units of phenylephrine products purchased, amounting to $3.4 billion in pharmacy expenditures, reported Timothy S. Anderson, MD, MAS, of the University of Pittsburgh, and co-authors.

As for pseudoephedrine products, 13.2 billion units of products were purchased, amounting to $3.8 billion in pharmacy expenditures, with units of phenylephrine purchased outpacing pseudoephedrine in all years, they noted in a research letter in JAMA.

There was no significant monotonic trend (P=0.11) in phenylephrine sales over the study period, while pseudoephedrine sales decreased significantly, from 1.68 billion units in 2012 to 0.98 billion units in 2021 (P<0.001).

The FDA began examining the efficacy of oral phenylephrine in 2007 following a citizen’s petition and held an advisory committee meeting on the issue that same year, with similar conclusions on a lack of efficacy.

In September 2023, all 16 voting members of the Nonprescription Drugs Advisory Committee voted against phenylephrine being effective for nasal congestion when used as labeled. Furthermore, no members favored additional studies into phenylephrine pharmacokinetics or higher doses to try to rescue its OTC use.

Anderson and team noted that the 2020 Coronavirus Aid, Relief, and Economic Security Act amended 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,” they 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.”

In October 2023, CVS Health announced that they would be voluntarily pulling a number of cold medications that contain phenylephrine from their shelves. Other cold medicines would remain available.

During the study period, there were 732 unique phenylephrine products (21 stand-alone, 711 combination products) and 495 pseudoephedrine products (54 stand-alone, 441 combination products). By 2021, there were 47 unique phenylephrine-containing formulations and 32 pseudoephedrine-containing formulations.

Among the phenylephrine-containing formulations, 85.5% contained three or more active ingredients, most commonly analgesics and antitussives, compared with 15.8% of pseudoephedrine-containing formulations.

This study used IQVIA’s Multinational Integrated Data Analysis quarterly U.S. pharmaceutical sales volume data from 2012 to 2021. Pharmaceutical products purchased by both retail and non-retail outlets, including mail order pharmacy services, grocery stores with pharmacies on site, and chain and independent pharmacies, among others, were counted as sales.

Anderson and team noted that facilities that sold these products but did not have a pharmacy on the premises were not included in the study analysis, which was a limitation. Additionally, the researchers were not able to estimate consumer spending.

“The delays between concerns about 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 postmarket evaluations,” the authors concluded.

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