FDA to Phase Out Common Cold Medicine Ingredient, Citing Ineffectiveness
Common Cold Medicine Ingredient Facing Removal From Shelves
FDA Proposes Banning Phenylephrine, citing Lack of Effectiveness
WASHINGTON – Get ready for a shakeup in teh cold and cough aisle. U.S. officials are moving to phase out phenylephrine, the leading decongestant found in hundreds of over-the-counter medications, after concluding it doesn’t actually relieve nasal congestion.
This decision, announced by the Food and Drug Management (FDA) last month, follows years of debate and research questioning the drug’s efficacy. If finalized, it will force drugmakers to remove or reformulate popular products like Sudafed and Dayquil, impacting a market worth roughly $1.8 billion annually.
“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,” said 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 really will help them.”
Why the Change?
The FDA’s decision comes after a panel of self-reliant experts unanimously voted last year that oral phenylephrine medications haven’t been shown to relieve congestion.
Recent, large-scale studies indicated that phenylephrine was no better than a placebo at clearing nasal passageways. Experts also revisited older studies from the 1960s and 1970s that supported the drug’s initial use, finding numerous flaws and questionable data.
This isn’t the first time phenylephrine has faced scrutiny. Researchers at the University of Florida petitioned the FDA to revisit the drug’s use in 2007 and again in 2015, raising concerns about its effectiveness.
what’s Next for Consumers?
While oral phenylephrine medications will remain on shelves for some time, consumers will likely need to explore alternatives for congestion relief.
Here are some options:
Pseudoephedrine: This older 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 nasal sprays and solutions, including saline drops and rinses, offer speedy relief.
* nasal Steroids: For long-term relief from seasonal allergies and stuffiness, doctors recommend nasal steroids like Flonase, Nasacort, and Rhinocort.
Why Doesn’t Phenylephrine Work When Taken Orally?
Experts believe phenylephrine is quickly broken down and rendered ineffective when it hits 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.”
A Long Road Ahead
The FDA’s proposal to revoke phenylephrine’s use in oral medications kicks off a lengthy public process. The agency must take comments from consumers and companies for six months, review the feedback, and then issue a final order. Even after that, drugmakers will likely have a year or more to remove or reformulate products.
While the Consumer Healthcare Products association, which represents medicine makers, wants to keep the products available, researchers like Hatton believe consumers deserve better.”Our position is that choosing from something that doesn’t work isn’t really a choice,” Hatton said.