Phenylephrine, an ingredient in popular over-the-counter cold and allergy medicines, doesn’t work, a US Food and Drug Administration (FDA) advisory committee determined Tuesday. The ingredient, a nasal decongestant, is found in brands like Benadryl, Mucinex, Sudafed, Nyquil, and Tylenol.
The Nonprescription Drugs Advisory Committee (NDAC) met Sept 11-12 to discuss the latest efficacy data for orally administered phenylephrine as a nasal decongestant and whether the oral nasal decongestants phenylephrine (PE) hydrochloride and phenylephrine bitartrate should be reclassified as not Generally Recognized as Safe and Effective (GRASE) due to lack of efficacy.
The committee pointed to three clinical trials conducted since the last NDAC meeting in 2007, asserting the trials demonstrate the ingredient is ineffective and requesting that both oral phenylephrine salts be reclassified as Not GRASE.
“We are aware that a number of excellent treatments are available for the treatment of nasal congestion and, in particular, congestion associated with allergic rhinitis. That stated…a significant amount of money is spent by consumers every year on the purchase of products that contain at least one ingredient (oral PE) that may not be effective. In addition to avoiding unnecessary costs of taking a drug with no benefit and lowering of overall healthcare costs, other potential benefits might be derived by changing the GRASE status of oral PE,” says the committee in a briefing document.
“These include but are not limited to avoiding any delay in care due to taking a drug that has no benefit, avoiding the risks of potential allergic reactions or other side effects related to use of PE in combination products, avoiding the inherent risks (especially for combination therapies) of taking more in order to seek some benefit, avoiding the risks of medication use in children, and avoiding missed opportunities for use of more effective treatments (including seeing a doctor if needed).”
The committee noted that customers could be negatively affected if oral PE is no longer available for purchase but said that “most consumers may simply need instruction on the alternatives, including how to obtain ‘behind-the-counter’ pseudoephedrine or to use alternative treatments, including intranasal decongestants (including intranasal PE), intranasal steroids, intranasal antihistamines, or intranasal saline products.”
The 16-member panel voted unanimously that oral formulations of the ingredient are ineffective.
The committee noted that, during its review, it didn’t identify any safety issues with orally administered PE products.
Regulations for phenylephrine remain unchanged, and there is no change in the availability of products containing the ingredient. The vote was a non-binding suggestion for the FDA to consider.
“We are disappointed by the outcome of today’s FDA Advisory Committee meeting because its non-binding recommendation is at odds with the numerous clinical trials and previous regulatory determinations affirming oral PE as a safe and effective decongestant at its labeled dose,” says Consumer Healthcare Products Association president and CEO Scott Melville in a statement. “…We encourage FDA, before making any regulatory determination, to be mindful of the totality of the evidence supporting this long-standing OTC ingredient, as well as the significantly negative unintended consequences associated with any potential change in oral PE’s regulatory status. While we respect the scientific and public process that allows new science to influence health policy and regulations, we are concerned about previous clinical evidence being inappropriately dismissed and discounted. We look forward to working with FDA in the coming days to further discuss how to best move forward in the interest of patients and consumers.”
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