- Phenylephrine is everywhere and every nasal decongestant contains it
- The vote deeming it ineffective paves the way for its withdrawal from the market
- READ MORE: FDA to Reevaluate Ineffective Over-the-Counter Drugs
The Food and Drug Administration has ruled that a nasal congestion medicine found in common decongestants is ineffective.
The ingredient phenylephrine is the most common active ingredient in over-the-counter medications, including Benadryl Allergy Plus Congestion, Sudafed PE, and Tylenol Cold and Flu Severe Day & Night.
But FDA agency reviewers said earlier this week that the oral decongestant is “ineffective” at standard or even high doses because it is metabolized in the intestines and does not reach the nose to provide relief.
The active ingredient is protected under the FDA’s GRASE (General Recognized as Safe and Effective) designation, but it is likely the agency will withdraw its approval. But withdrawing that designation would mean that companies would have to take them off the shelves.
The FDA’s vote to declare the ingredient ineffective was unanimous, paving the way for its withdrawal as an approved product
Phenylephrine is ubiquitous, so much so that almost every nasal decongestant on pharmacy shelves contains it.
If the agency decides to revoke the GRASE designation, manufacturers could be required to withdraw their drugs from the market or reformulate them to contain an approved active ingredient.
It was approved by the FDA in the 1970s to shrink dilated blood vessels in the nose, relieving nasal and sinus congestion.
But since then, more research has emerged questioning whether oral formulations of the drug have any measurable benefit, given how it is metabolized in the body.
The medicine is metabolized in the intestines, with only a small amount entering the bloodstream and reaching the nose.
In fact, briefing documents compiled by the FDA show as much less than one percent concentration of the drug can reach the nose after being broken down in the intestines.
In 2007, pharmacy professors at the University of Florida filed a petition urging the FDA to investigate whether a 10-milligram pill of phenylephrine worked as a decongestant.
They said in a meta-analysis of available data: ‘Thus, the results of the studies reported after the 2007 Advisory Committee meeting clearly demonstrate that (phenylephrine) is no more effective than placebo in reducing nasal congestion and that quadrupling the dose did not yield results. extra advantage.’
Since then, a series of studies have emerged pointing to its ineffectiveness.
In 2015, a study sponsored in part by New Jersey-based pharmaceutical company Merck & Co found that the 10-milligram dose, as well as the 20, 30, or 40-milligram doses, “were not significantly better than placebo in relieving stuffy nose’ in a sample of 539 adults.