The US Food and Drug Administration (FDA) has proposed removing oral phenylephrine as an active ingredient in over-the-counter (OTC) medications for temporary nasal congestion relief. This decision follows an agency review revealing insufficient evidence supporting its effectiveness. Although companies can currently continue marketing oral phenylephrine-containing products, a final order will ultimately determine their marketability. Notably, the FDA's concerns pertain to effectiveness, not safety.
Oral phenylephrine is currently a common active ingredient in numerous over-the-counter (OTC) nasal decongestant products. These products come in two forms: those containing oral phenylephrine alone and combination products paired with ingredients like acetaminophen or dextromethorphan. Notably, the presence of oral phenylephrine does not impact the effectiveness of accompanying ingredients in treating their intended symptoms.
The FDA's primary responsibility is ensuring drugs are both safe and effective. Following a thorough review of available data and guidance from our advisory committee, we propose removing oral phenylephrine as a nasal decongestant due to its lack of effectiveness.Patrizia Cavazzoni, M.D., Director of the FDA's Center for Drug Evaluation and Research
According to Patrizia Cavazzoni, M.D., Director of the FDA's Center for Drug Evaluation and Research, "The FDA's primary responsibility is ensuring drugs are both safe and effective. Following a thorough review of available data and guidance from our advisory committee, we propose removing oral phenylephrine as a nasal decongestant due to its lack of effectiveness."
The FDA conducted a thorough review of oral phenylephrine's safety and efficacy, encompassing historical data from 30 years ago that initially justified its use as a nasal decongestant, along with subsequent clinical studies that have shed new light on its effectiveness.
The FDA convened a Nonprescription Drug Advisory Committee meeting last fall to evaluate oral phenylephrine's status as "Generally Recognized as Safe and Effective" (GRASE) for nasal decongestant use. After reviewing fresh evidence, the committee unanimously agreed that existing scientific data fails to support oral phenylephrine's effectiveness at recommended dosages in over-the-counter medications for colds, coughs, allergies, bronchodilators, and anti-asthmatics.
Theresa Michele, M.D., Director of the Office of Nonprescription Drug Products in CDER, assures consumers that numerous safe and effective treatments are available to temporarily alleviate congestion symptoms from allergies or common colds.
Theresa Michele, M.D., Director of the Office of Nonprescription Drug Products in CDER, assures consumers that numerous safe and effective treatments are available to temporarily alleviate congestion symptoms from allergies or common colds. By consulting their doctor or pharmacist, individuals can identify the best option for their specific needs.
Consumers should carefully read the Drug Facts label to identify ingredients, warnings and usage directions, as multiple products with differing formulations may share the same brand name. Notably, the FDA's action targeting oral phenylephrine does not impact nasal spray formulations containing phenylephrine, which remain effective congestion treatments.
The FDA invites public input on the proposed order regarding oral phenylephrine's effectiveness as a nasal decongestant. Instructions for submitting comments are available in the proposed order on OTC Monographs@FDA. After reviewing comments, if the FDA confirms oral phenylephrine's ineffectiveness, a final order will be issued, prompting manufacturers to reformulate or withdraw affected products within a specified timeframe.
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