FDA rules TODAY that Benadryl and Sudafed from pharmacy shelves don’t work

The Food and Drug Administration ruled that a medicine for nasal stuffiness found in common decongestants is ineffective.

The ingredient phenylephrine is the most common active compound 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 earlir this week that the oral decongestant ‘is not effective’ at standard or even high doses because it is metabolized in the gut and does not reach the nose to bring relief.

The active ingredient is protected under the FDA’s Generally Recognized as Safe and Effective (GRASE) designation, but it is likely that the agency will pull it’s approval. But revoking that designation would mean companies would have to pull them from shelves.

Phenylephrine is everywhere, so much so that nearly every nasal decongestant on pharmacy shelves contains it.

If the agency decides to pull its GRASE designation, manufacturers may be required to pull their medicines from the market or reformulate them to contain an approved active ingredient.  

It was approved by the FDA in the 1970s to shrink the dilated blood vessels in the nose, relieving nasal and sinus congestion.

But since then, more research has come out questioning whether oral formulations of the medicine have any measurable benefit, given the way it’s metabolized in the body.

The medicine is metabolized in the gut, allowing just a tiny bit to enter the bloodstream, which is how it reaches the nose. 

In fact, briefing documents compiled by the FDA show that less than a one percent concentration of the drug is able to reach the nose after being broken down in the gut.

In 2007, pharmacy professors at the University of Florida put forth a petition pressing the FDA to review whether a 10 milligram phenylephrine pill 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 decreasing nasal congestion and increasing the dose fourfold did not provide additional benefit.’

A series of studies pointing to its ineffectiveness have come out since then.

In 2015, a study sponsored in part by the New Jersey-based pharmaceutical company Merck & Co found that the the 10 milligram dose, as well as 20, 30, or 40 milligram doses were ‘not significantly better than placebo at relieving nasal congestion’ in a sample of 539 adults.