Whether you’re congested from a cold, the flu, COVID or allergies, chances are you’ve reached for some relief in an over-the-counter medication. Oftentimes, the decongestant in these medications is phenylephrine. However, an FDA advisory panel recently concluded that the decongestant phenylephrine is ineffective at reducing sinus congestion during colds when taken orally.
While this may be breaking news to many consumers, this is not a new finding, as research has shown for a while that pseudoephedrine, another oral decongestant, is more effective than phenylephrine. Unfortunately, pseudoephedrine is also a main ingredient used to make methamphetamine, so it faces more restrictions. In 2005, the Combat Methamphetamine Epidemic Act was passed, banning over-the-counter sales of cold medicines that contained the ingredients pseudoephedrine, ephedrine, and phenylpropanolamine. After the act was passed, all products containing pseudoephedrine were reclassified as either “Pharmacist Only Medicines” (Schedule 3) or “Prescription Only Medicines” and most cough and cold medication manufacturers turned to phenylephrine to replace pseudoephedrine in their OTC products.
Phenylephrine is supposed to work by reducing swelling of the blood vessels in the nasal passages, making it easier to breathe. But when taken in pill form, scientists believe that phenylephrine is absorbed by the stomach and processed so effectively that only a small amount reaches the bloodstream, which is essential for reaching the nose.
What This Means for You
Ultimately, experts stress that phenylephrine isn't dangerous, and it is still effective when used as a nasal spray or as drops to dilate the eyes. However, it can be harmful to your wallet if you're buying a pill that's ineffective in relieving congestion. In the past, consumers could take joy in the fact that phenylephrine was oftentimes cheaper than pseudoephedrine, but that isn’t as sweet of a deal if you’re not finding any symptom relief.
The advisory panel was in agreement that their recommendation to the FDA wasn't primarily based on safety concerns. Instead, they were urging the FDA to take action because these tablets were seen as a poor use of money, and over-the-counter medications were considered more effective in assisting individuals with colds or allergies.
“It’s amazing the amount of dollars being spent on something that has really no efficacy,” says committee member Dr. William Fig, a clinical pharmacologist and investigator at the National Cancer Institute.
Products containing phenylephrine, including those sold by big brands such as Tylenol, Advil, Sudafed, and Mucinex, generated nearly $1.8 billion in sales in 2022, meaning a change to phenylephrine’s designation could be costly to manufacturers. The Consumer Healthcare Products Association, which represents companies that make non-prescription medicines, supplements, and medical devices, is against a change in regulations.
They expressed their disappointment with the advisory panel’s decision and advised the FDA to consider all the evidence supporting the use of over-the-counter oral phenylephrine (PE) over the years. They also warned the FDA to be cautious about any unintended negative consequences that could result from changing the regulatory status of oral PE.
The association informed the FDA advisory panel that their surveys indicate people prefer decongestant tablets over nasal sprays, and emphasized that discontinuing these medications could be a significant inconvenience for consumers.
When you’re sick or congested, you want to take something you know will provide some relief, and you should be able to trust that the medication on the shelf will help alleviate those symptoms. Nevertheless, the advisory panel recognized that if the FDA decides to reclassify phenylephrine, potentially leading to its removal from the market, the FDA will need to explain to the public why certain well-known allergy and cold medications are no longer accessible.
The FDA wants everyone to know that they have the final say in this matter. If the FDA decides that oral phenylephrine isn't effective, they will propose a rule to remove it from the GRASE category. GRASE stands for "Generally Recognized as Safe and Effective."
Then, they will let the public share their thoughts on this decision. If the FDA still believes it's ineffective, they will make a final ruling to take it off the GRASE list. However, this change would only apply to the tablet form of the medication; the nasal spray version would remain available.
The FDA will collaborate with manufacturers to modify products as needed, ensuring that safe and effective options for treating cold or allergy symptoms are still accessible.
If phenylephrine tablets are no longer on the market, don’t fret, there are other over-the-counter choices, such as antihistamine nasal sprays, nasal corticosteroids, and saline nasal products. Additionally, medications containing pseudoephedrine are still available for purchase behind the pharmacy counter.
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