FDA questions efficacy of popular cold medicine ingredient

FDA advisory panel finds phenylephrine, an ingredient in popular cold medicines, ineffective.
Rizwan Choudhury
Cold and flu medicine sits on a store shelf.
Cold and flu medicine sits on a store shelf.

Source: Joe Raedle /Getty Images 

If you thought grabbing some Benadryl or Sudafed PE was your secret weapon against a gnarly cold, you might want to sit down.

In a potentially industry-altering decision, a Food and Drug Administration advisory panel dropped big news this week. Here's how this could change the way you choose your next over-the-counter flu medications.

An FDA advisory panel unanimously decided that phenylephrine, an ingredient frequently used in many over-the-counter cold medicines, is about as useful as a screen door on a submarine. That's right, folks, it's ineffective.

Why does this matter?

The recent findings serve as a preliminary step for the FDA, which may eventually consider revising the formulation of a wide array of cold and flu medications. This could impact well-regarded brands such as Tylenol, Mucinex, and Benadryl.

The Consumer Healthcare Products Association has issued a warning that echoes like a winter cough in a quiet room. Suppose the FDA acts on the panel's recommendations. In that case, the impact will ripple through the market like an unwanted fever, potentially making several popular products disappear faster than one can imagine.

According to the New York Times, which got the scoop first, FDA officials often follow the advisory panel's recommendations. But don't hold your breath just yet. There's a lengthy process, and these findings could be disputed. Cue the courtroom dramas and heavy lobbying.

What the experts are saying

Before you go raiding your medicine cabinet for mass disposal, know that the FDA still insists that phenylephrine is effective if used as a nasal spray, applied in surgical procedures, or utilized to dilate the eyes. In the interim, experts urge consumers not to discard their existing medications in haste. "If you have a stuffy nose and take this medicine, you will still have a stuffy nose, but it is not harmful," emphasized Dr. Leslie Hendeles, a pharmacist from the University of Florida. Hendeles was among the first to petition the FDA for the removal of phenylephrine back in 2007.

Multiple studies assessed that orally consumed phenylephrine is largely neutralized in the gut, rendering it ineffective in tablet, capsule, or liquid forms.

The issue is that they may only help you a little. Dr. Maria Coyle, the panel chairwoman and an associate professor at Ohio State University, minced no words: "We have better options... the studies do not support that this is an effective drug."

Product implications

Phenylephrine is currently an ingredient in at least 250 products, which collectively accounted for nearly $1.8 billion in sales last year, according to agency data. An FDA move to ban the ingredient could wreak havoc on product formulations, forcing companies into a race against time to reformulate their products.

In a preemptive move, the Consumer Healthcare Products Association (CHPA), the voice of drug manufacturers, released a statement defending phenylephrine. They cited a survey claiming that 83% of Americans find it beneficial and warn that pulling it from the market could create negative consequences.

CHPA says people might avoid seeking professional medical advice if their OTC options diminish. Plus, alternative decongestants like pseudoephedrine are not as easily accessible due to purchase restrictions—thanks to its potential for methamphetamine production. "This poses unequal burdens for consumers," said the CHPA.

What happens next?

The panel's recommendation has initiated a potential administrative process that could result in the banning of the ingredient, upending the formulations of popular brands such as Tylenol, Mucinex, and Benadryl. Efforts to delay this decision through lawsuits and lobbying are anticipated. If companies are forced to reformulate, they may be given a grace period.

Several other oral decongestants, such as pseudoephedrine and nasal sprays containing oxymetazoline, are still considered effective. Additionally, other medicines like nasal steroids Flonase are also available for similar symptoms.

The ball is now in the FDA’s court as it contemplates whether to proceed with a formal vote to ban phenylephrine altogether.

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