HWN Suggests

The Uselessness of Phenylephrine

Why is oral phenylephrine so useless? It is extensively metabolized, starting in the gut wall. You can find a bioavailability figure of 38% in the literature, but that appears to be the most optimistic number possible, and you can also find studies that show 1% or less. Overall, the Cmax is highly variable patient-to-patient, and the lack of cardiovascular effects at low doses argues for very low systemic effects (and expected low efficacy as a decongestant). The bioavailability increases at higher doses as you apparently saturate out some of the metabolic pathways, but at the 10mg dose typically used for decongestants, you can forget it.

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 Why Has a Useless Cold Medication Been Allowed on Shelves for Years?

Studies prove that popular decongestants just don’t work.

Articles of Interest

A Decongestant in Cold Medicines Doesn’t Work at All, an F.D.A. Panel Says

The agency now must decide whether products containing the ingredient, like some Sudafed and NyQuil products, should no longer be sold or perhaps give companies lead time to substitute other ingredients.

A popular nasal decongestant doesn't actually relieve congestion, FDA advisers say

The leading decongestant used by millions of Americans looking for relief from a stuffy nose is no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient.

Decongestant in Cold Medicines Found Ineffective

Phenylephrine, first permitted for use in 1938, didn’t go through the rigorous clinical trials that regulators require today for medications, and more recent studies found the ingredient to be ineffective at relieving congestion. The latest research prompted pharmacists and physicians to call for ending the sales of the drugs.

Here’s Why Many Decongestants May Soon Disappear From Store Shelves

Some of the most common cold medications like Benadryl, Mucinex and variations of Tylenol may soon be forced off shelves after a Food and Drug Administration panel found oral phenylephrine to be ineffective, potentially forcing drug companies to reformulate products and consumers to turn to nasal sprays to fight congestion.

Regular Cold Medicine Doesn’t Work, FDA Admits After Biggest Cold Medicine Sales Boom in History

The agency said that three large recent industry-funded studies evaluating medicines with phenylephrine by manufacturers found that people who took medicines with phenylephrine fared no better than those who received a placebo. The agency also found that research from decades ago didn’t meet current clinical trial design standards and included inconsistent results.