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FDA advisory committee finds formulation of nasal decongestant PE not effective

The FDA advisory committee's decision could lead to this formulation of the drug being taken off the market.
Sandra Levy
Senior Editor
Levy

On Tuesday, the Food and Drug Administration advisory committee voted unanimously that the oral formulation of a very common nasal decongestant, phenylephrine, is not effective in relieving congestion. 

PE is the ingredient in many over-the-counter cold and allergy medications, such as some versions of Nyquil, Benadryl, Sudafed PE and Mucinex. 

The FDA typically follows the advice of its advisory committees but it is not required to do so.

The FDA could potentially take action to start a process that takes phenylephrine off the market. This could result in manufacturers being required to take these widely popular cough and cold medications off store shelves and reformulate those products. 

The Consumer Healthcare Products Association responded to the advisory committee's vote with a statement from CHPA president and CEO Scott Melville:

“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 phenylephrine (PE) as a safe and effective decongestant at its labeled dose," Melville said.

[Read more: A return to nature]

Melville added, “As stated in the FDA briefing document and highlighted by the committee chair, FDA has not identified any safety issues with orally administered PE. The meeting was a scientific review of recent research on PE efficacy.”

“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,” Melville concluded.

 

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