By CAILLEY LAPARA | Bloomberg
A panel of regulatory advisers in the US has unanimously recommended that phenylephrine, a key ingredient in certain over-the-counter cold medicines, including some versions of Procter & Gamble Co.’s Nyquil, has no proven effectiveness.
The committee, composed of 16 advisers to the Food and Drug Administration (FDA), concluded that there is insufficient scientific evidence to support the efficacy of oral phenylephrine at recommended doses. Furthermore, the majority of panelists agreed that conducting further studies to test higher doses of the drug would not be worthwhile.
While the advisory committee’s decision is not binding, the FDA’s own staff have also expressed doubts about the efficacy of phenylephrine. Should the agency follow the panel’s recommendation, it could initiate the process of removing the drug from the market. This would require manufacturers, including P&G, Kenvue Inc. (Sudafed), and Reckitt Benckiser Group (Mucinex), to reformulate their popular cough and cold products.
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The companies mentioned did not respond to requests for comment.
According to the FDA, consumers spent approximately $1.8 billion on products containing phenylephrine in 2022. However, many cold remedies that contain the decongestant also contain other active ingredients such as antihistamines and cough suppressants.
As a substitute for pseudoephedrine, phenylephrine has increasingly been used in non-prescription cold remedies. Pseudoephedrine, commonly found in Sudafed, can be utilized to make illegal forms of methamphetamine. Since 2006, the US government has required medicines containing pseudoephedrine to be kept behind the counter.
Pharmacist’s Dilemma
Diane Ginsburg, a clinical professor of pharmacy practice at the University of Texas at Austin and one of the outside experts on the panel, highlighted the ethical dilemma that pharmacists would face if phenylephrine-containing products remain on the market. She stated at the meeting on Tuesday, “That just erodes trust that patients have with us.”
Panelists and industry representatives expressed concerns that removing these products from drugstore shelves could confuse consumers and potentially limit their ability to self-treat with easily accessible over-the-counter remedies.
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Others argued that remedies like nasal sprays and cold medicines that are kept behind the pharmacy counter are still available and effective. They contended that continuing to market ineffective products would pose greater risks to patients.
“People really don’t like change, and this is going to change how the cold and cough aisle looks,” explained panelist Susan Blalock, a behavioral scientist at the University of North Carolina’s Eshelman School of Pharmacy. “FDA really shouldn’t underestimate the communication challenges.”
Assistance provided by Fiona Rutherford.
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