FDA to Phase Out Common Decongestant, Citing Ineffectiveness
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FDA moves to Phase Out Common Cold Medicine Ingredient, Citing ineffectiveness
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WASHINGTON – Get ready for a shakeup in teh cold and cough aisle. U.S. officials are taking steps to remove phenylephrine, a common decongestant found in hundreds of over-the-counter medications, from the market. The Food and Drug Administration (FDA) concluded that the ingredient, present in popular brands like Sudafed and Dayquil, doesn’t actually relieve nasal congestion.
This decision comes after years of debate and follows a unanimous vote by federal advisors last year who found oral phenylephrine medications ineffective.”People walk into the drugstore today and see 55,000 medicines on the shelf and they pick one that is definitely not going to work,” saeid Dr.brian Schroer of the Cleveland Clinic.”You take away that option and it will be easier for them to self-direct toward products that realy will help them.”
Why the Change?
Recent large-scale studies have shown that phenylephrine is no better than a placebo at clearing stuffy noses. Experts also re-examined older studies that initially supported the drug’s use, finding significant flaws and questionable data.
The FDA’s proposal specifically targets oral phenylephrine medications, which generate roughly $1.8 billion in annual U.S. sales. Nasal sprays containing phenylephrine, though less popular, are still considered effective.
What’s Next for Consumers?
The FDA’s proposal kicks off a lengthy process that includes a six-month public comment period and further review. Drugmakers will likely have a year or more to remove or reformulate products containing phenylephrine once the final order is issued.
Meanwhile, consumers seeking relief from congestion will need to explore alternatives.Alternatives to Phenylephrine
Pseudoephedrine: This decongestant, found in products like Sudafed and Claritin D, remains available behind the pharmacy counter.Purchasers need to provide a photo ID. Nasal Sprays and Solutions: Over-the-counter saline drops and rinses offer a swift way to clear mucus. For long-term relief,nasal steroids like Flonase,Nasacort,and Rhinocort are highly effective when used daily. Antihistamine sprays like Astepro provide faster relief for short-term congestion.
* Phenylephrine Nasal Sprays: These will remain available on pharmacy shelves.
Why Doesn’t Oral Phenylephrine Work?
Experts believe that phenylephrine is broken down and rendered ineffective in the stomach.
“This is a good drug, but not when it’s swallowed,” said Leslie Hendeles, professor emeritus at the University of Florida’s College of Pharmacy. “It’s inactivated in the gut and doesn’t get into the bloodstream, so it can’t get to the nose.”
Even higher doses of phenylephrine have proven ineffective, and raising the dosage further coudl pose safety risks due to the drug’s potential to increase blood pressure.The FDA’s move to phase out phenylephrine marks a significant shift in the over-the-counter cold and allergy market. While the process will take time, it ultimately aims to provide consumers with more effective options for relieving congestion.
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