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FDA wants to ban useless oronasal phenylephrine meds

by · Boing Boing

Oral phenylephrine is sold as a nasal decongestant. It doesn't work very well, and the U.S. Food and Drug administration wants it removed from over-the-counter medications.

The agency conducted a comprehensive review of all available data on the safety and efficacy of oral phenylephrine, including the historical data that were used to support the determination made 30 years ago that oral phenylephrine was effective as a nasal decongestant, as well as newer clinical data on oral phenylephrine that have since become available. 

Last fall, the FDA also held a Nonprescription Drug Advisory Committee meeting to discuss the 'Generally Recognized as Safe and Effective' (GRASE) status of oral phenylephrine as a nasal decongestant. The committee discussed new data on the effectiveness of orally administered phenylephrine and unanimously concluded that the current scientific data do not support that the recommended dosage in the OTC cold, cough, allergy, bronchodilator and antiasthmatic drug products monograph for orally administered phenylephrine's effectiveness as a nasal decongestant.

Afrin (oxymetazoline) works but is a pretty horrible drug otherwise and doctors recommend against use day after day. Another nasal ingredient that worked, pseudoephedrine, was restricted because of the potential for abuse, and so we marched into the age of phenylephrine-based replacements that don't. That there are a myriad of same-branded sprays with different ingredients is part of the problem for stuffy consumers.