Phenylephrine, a common decongestant in medicines is no better than a placebo when taken orally, says a US FDA advisory panel

by Wes Davis

A key cold medicine ingredient is basically worthless

The FDA’s 16-member advisory panel unanimously voted yesterday that oral phenylephrine, a common active ingredient in cold medications, is no better than a placebo for treating congestion.

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The call by the panel sets up potential FDA action that could force the removal of certain over-the-counter medications containing the ingredient — including certain formulations of Mucinex, Sudafed, Tylenol, and NyQuil — from store shelves.
But FDA may hold off for many months, pending contested findings by drug makers and other considerations.

Data

Newer data from studies the panel says are more consistent with modern clinical trial standards showed phenylephrine simply “was not significantly different from placebo” in the recommended dosage, including trials from 2007 that the FDA had reviewed when considering the drug after a citizen petition prompted it to do so.

Bioavailability

The panel cited the drug’s low bioavailability, a term referring to qualities that allow the drug to be absorbed by the human body, as the main reason the drug should be removed from the market.

Jennifer Schwartzott said the drug “should have been removed from the market a long time ago,” while Dr. Stephen Clement said that although the drug itself isn’t dangerous, its usage by patients should be considered unsafe because it potentially delays actual treatment of disease symptoms.

Alternative

The panel cited pseudoephedrine as an effective alternative though while it’s technically available without a prescription, you must talk to a pharmacist to get it because, in large quantities, it can be used to make methamphetamines.