Oral phenylephrine, widely known as phenylephrine hydrochloride, is a common ingredient in India’s OTC market, where it’s used to relieve nasal congestion related to colds, flu, and allergies.
Published Nov 11, 2024 | 8:00 AM ⚊ Updated Nov 11, 2024 | 8:00 AM
In a significant regulatory move, the US Food and Drug Administration (FDA) has proposed the removal of oral phenylephrine as an active ingredient in over-the-counter (OTC) medications for nasal congestion relief.
The move followed an agency review that found the ingredient ineffective for the stated purpose.
Oral phenylephrine, widely known as phenylephrine hydrochloride, is a common ingredient in India’s OTC market, where it’s used to relieve nasal congestion related to colds, flu, and allergies. Available in tablet and liquid forms, it is often combined with other ingredients in popular cold and cough medicines.
However, the FDA’s recent findings may prompt a reconsideration of its role in such products, especially as the advisory committee unanimously concluded that oral phenylephrine does not effectively alleviate congestion.
“The FDA is proposing to remove oral phenylephrine as an active ingredient in OTC monograph drug products for temporary relief of nasal congestion, following a review that determined it is not effective,” stated the FDA.
For now, products containing oral phenylephrine can remain on the market until a final order is issued. The proposal focuses solely on effectiveness and is not based on safety concerns.
Oral phenylephrine, typically used as a standalone nasal decongestant or combined with other active ingredients such as acetaminophen or dextromethorphan, will continue to be marketed while the proposal awaits finalisation.
Dr Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research (CDER), explained, “It is the FDA’s responsibility to ensure drugs are safe and effective. Based on the advisory committee’s guidance and our review, we propose to remove oral phenylephrine as a nasal decongestant.”
In response to these findings, the FDA held a Nonprescription Drug Advisory Committee meeting in October 2023, where data was reviewed, leading the committee to unanimously conclude that available scientific evidence does not support the effectiveness of oral phenylephrine at the recommended dosage levels for nasal decongestion.
Meanwhile, India has taken regulatory action targeting certain phenylephrine-based combinations for young children.
In December 2023, the Central Drugs Standard Control Organisation (CDSCO) banned the use of a common cold fixed drug combination (FDC) containing phenylephrine and chlorpheniramine maleate for children under four years old.
This combination, frequently found in cough syrups, combines chlorpheniramine maleate, an antihistamine for allergy relief, with phenylephrine, a decongestant that narrows blood vessels to ease nasal congestion.
“Consumers should know there are safe and effective treatments available to relieve congestion due to allergies or colds,” Dr Theresa Michele, director of the FDA’s Office of Nonprescription Drug Products.
She advised consumers to consult healthcare professionals about suitable alternatives. The FDA emphasised that their proposed order applies only to orally administered phenylephrine, not to nasal sprays containing the same ingredient.
Despite FDA scrutiny, oral phenylephrine remains widely available in India in popular OTC products. No similar regulatory actions concerning oral phenylephrine have been announced by Indian authorities for adult use, making it readily accessible to consumers.
Mechanism of Action Phenylephrine acts as an alpha-1 adrenergic agonist, constricting blood vessels in nasal passages to reduce congestion. Its medical applications include:
The formulation affects its efficacy, with intranasal applications generally providing quicker relief from congestion.
(Edited by Majnu Babu).
