Gross sales of probably the most often used over the counter (OTC) oral decongestant, which was once deemed useless through FDA personnel and advisors final 12 months, remained secure thru 2021, and researchers warn that pulling the drug may just disrupt the availability chain.
In a cross-sectional find out about the usage of knowledge from 2012 to 2021, there have been 19.8 billion gadgets of phenylephrine merchandise bought, amounting to $3.4 billion in pharmacy expenditures, reported Timothy S. Anderson, MD, MAS, of the College of Pittsburgh, and co-authors.
As for pseudoephedrine merchandise, 13.2 billion gadgets of goods had been bought, amounting to $3.8 billion in pharmacy expenditures, with gadgets of phenylephrine bought outpacing pseudoephedrine in all years, they famous in a analysis letter in JAMA.
There was once no vital monotonic development (P=0.11) in phenylephrine gross sales over the find out about duration, whilst pseudoephedrine gross sales lowered considerably, from 1.68 billion gadgets in 2012 to 0.98 billion gadgets in 2021 (P<0.001).
The FDA started analyzing the efficacy of oral phenylephrine in 2007 following a citizen’s petition and held an advisory committee assembly at the factor that very same 12 months, with identical conclusions on a loss of efficacy.
In September 2023, all 16 vote casting participants of the Nonprescription Medication Advisory Committee voted towards phenylephrine being efficient for nasal congestion when used as classified. Moreover, no participants preferred further research into phenylephrine pharmacokinetics or upper doses to check out to rescue its OTC use.
Anderson and crew famous that the 2020 Coronavirus Support, Aid, and Financial Safety Act amended the regulatory procedure for nonprescription medicine, “offering a mechanism to administratively take away medicine now not deemed efficient.”
“If the FDA follows its advisory board advice and problems a proposed order to take away oral phenylephrine from its ‘OTC monograph,’ reformulation of all phenylephrine-containing merchandise can be required, which can have ramifications for provide chains,” they wrote. “All through the time required for reformulation and creation of latest merchandise, clinicians and shoppers may just imagine oral pseudoephedrine or intranasal decongestants, together with phenylephrine or oxymetazoline, as choices.”
In October 2023, CVS Well being introduced that they might be voluntarily pulling various chilly drugs that include phenylephrine from their cabinets. Different chilly drugs would stay to be had.
All through the find out about duration, there have been 732 distinctive phenylephrine merchandise (21 stand-alone, 711 aggregate merchandise) and 495 pseudoephedrine merchandise (54 stand-alone, 441 aggregate merchandise). Via 2021, there have been 47 distinctive phenylephrine-containing formulations and 32 pseudoephedrine-containing formulations.
Some of the phenylephrine-containing formulations, 85.5% contained 3 or extra lively components, maximum often analgesics and antitussives, when compared with 15.8% of pseudoephedrine-containing formulations.
This find out about used IQVIA’s Multinational Built-in Information Research quarterly U.S. pharmaceutical gross sales quantity knowledge from 2012 to 2021. Pharmaceutical merchandise bought through each retail and non-retail retailers, together with mail order pharmacy products and services, grocery shops with pharmacies on web page, and chain and unbiased pharmacies, amongst others, had been counted as gross sales.
Anderson and crew famous that amenities that bought those merchandise however didn’t have a pharmacy at the premises weren’t integrated within the find out about research, which was once a limitation. Moreover, the researchers weren’t ready to estimate shopper spending.
“The delays between issues about efficacy of oral phenylephrine being raised and FDA motion spotlight the will for endured reform of the nonprescription drug overview procedure, akin to increasing the capability of the FDA Place of work of Nonprescription Medication and making an investment in knowledge infrastructure to permit timelier postmarket opinions,” the authors concluded.
This find out about was once funded thru a occupation construction award from the Nationwide Institute on Growing old and a grant from the Canadian Institutes of Well being Analysis.
Anderson reported relationships with the American School of Cardiology, the American Center Affiliation, the U.S. Deprescribing Analysis Community, and the American Scientific Scholar Affiliation.
Number one Supply
Supply Reference: Anderson TS, et al “Developments in phenylephrine and pseudoephedrine gross sales in the USA” JAMA 2024; DOI: 10.1001/jama.2023.27932.