Popular cold, flu medicine could be pulled from market for ineffectiveness

Nov 08, 2024

Karah Rucker Anchor

By Karah Rucker (Anchor), Shea Taylor (Producer), Ian Kennedy (Lead Video Editor)

Cold and flu season is here and many may be reaching for medicine for relief but a popular remedy may soon no longer be available. The Food and Drug Administration said it’s planning to pull a widely used ingredient from shelves.

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It’s called oral phenylephrine and is used in cough and cold medicines from household names like Advil, NyQuil, Sudafed, Robitussin, Tylenol and Theraflu.

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More than a year ago, the FDA’s advisers voted against continuing to use the ingredient over concerns about the data used to support its approval and new data that shows it might not be effective. After that vote, CVS said it would pull any products on its shelves that only contained the product.

A 2022 study from the University of Florida found phenylephrine basically only had a placebo effect when swallowed. The latest FDA data, published this week, shows less than 1% of phenylephrine is absorbed into the body when taken orally through a pill or cough syrup.

Researches found it’s more effective in certain forms, like a nasal spray, because more can get into the bloodstream.

The public gets to weigh-in on the decision until May 7, then the FDA will decide whether to revoke its status as “generally recognized as safe and effective.”

Tags: CVS, FDA, Flu, U.S. Food and Drug Administration, University of Florida

[Karah]

COLD AND FLU SEASON IS UPON US AND THAT MIGHT HAVE YOU TURNING TO OVER-THE-COUNTER MEDICINE TO GET SOME RELIEF – BUT YOUR GO-TO CHOICE MAY NO LONGER BE AVAILABLE SOON.

THE FOOD AND DRUG ADMINISTRATION SAYS IT’S PULLING A WIDELY USED INGREDIENT FROM SHELVES.

IT’S CALLED ORAL PHENYLEPHRINE AND IS USED IN COUGH AND COLD MEDICINES FROM HOUSEHOLD NAMES LIKE ADVIL, NYQUIL, SUDAFED, ROBITUSSIN, TYLENOL AND THERAFLU.

MORE THAN A YEAR AGO, THE F-D-A’S ADVISERS VOTED AGAINST CONTINUING TO USE THE INGREDIENT – OVER CONCERNS ABOUT THE DATA USED TO SUPPORT ITS APPROVAL AND NEW DATA THAT SHOWS IT MIGHT NOT BE EFFECTIVE.

AFTER THAT VOTE – C-V-S SAID IT WOULD PULL ANY PRODUCTS ON ITS SHELVES THAT ONLY CONTAINED THE PRODUCT.

A 20-22 STUDY OUT OF THE UNIVERSITY OF FLORIDA FOUND PHENYLEPHRINE BASICALLY ONLY HAD A PLACEBO EFFECT WHEN SWALLOWED.

THE LATEST F-D-A DATA – PUBLISHED THIS WEEK – SHOWS LESS THAN ONE PERCENT OF PHENYLEPHRINE IS ABSORBED INTO THE BODY WHEN TAKEN ORALLY THROUGH A PILL OR COUGH SYRUP.

THEY FOUND IT’S MORE EFFECTIVE IN CERTAIN FORMS – LIKE A NASAL SPRAY – BECAUSE MORE CAN GET INTO THE BLOODSTREAM.

THE PUBLIC GETS TO WEIGH-IN ON THE DECISION UNTIL MAY 7-TH… THEN THE F-D-A WILL DECIDE WHETHER TO REVOKE ITS STATUS AS QUOTE ‘GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE.”

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