Is Popular Cold Medicine Ingredient Heading for the Shelf?
The U.S. Food and Drug Administration (FDA) has stirred controversy by proposing to remove a common ingredient from many over-the-counter cold medications: oral phenylephrine. The agency cites evidence that the ingredient, used as a nasal decongestant, simply doesn’t work as intended.
How Does Phenylephrine Work (or Not Work)?
“Phenylephrine is an oral decongestant and vasoconstrictor,” explains Dr. Aaron Stone, Valley Health Pharmacist. “By that, it means it tightens up the blood vessels and by doing that, it will hopefully clear up some sinus issues.” While this mechanism seems logical, studies have raised doubts about its efficacy.
“The FDA is there to ensure that products are effective and safe,” Stone said. “The study shows it’s not necessarily effective. That’s one reason some may say to get rid of it.”
There are also safety concerns surrounding phenylephrine. Being a vasoconstrictor, it can tighten blood vessels, potentially posing a risk to individuals with uncontrolled high blood pressure.
Phenylephrine in Your Medicine Cabinet
Phenylephrine lurks in various popular cold and sinus medications, including products like Vicks Dayquil, Mucinex Sinus Max, and any labeled with “PE” in the title. However, many pharmacies nationwide have already taken a proactive step and removed these products from their shelves.
A Silver Lining?
“A positive side we can look at is less confusion due to fewer choices,” Stone observed, “because if you look at the cough and cold aisle, you’ll see 20-30 different things.”
The potential removal of phenylephrine could simplify the consumer experience, making it easier to navigate the overwhelming array of cough and cold remedies.
What’s Next?
The FDA’s proposal is not an immediate order, but rather the start of a six-month public comment period. During this time, stakeholders, including the public, manufacturers, and medical professionals, can voice their opinions and provide evidence regarding the effectiveness and safety of oral phenylephrine.
Following this comment period, the FDA will carefully consider all input before making a final decision on whether to ban the ingredient from over-the-counter cold medications.
Alternative Relief: Step Up to Pseudoephedrine
Stone suggests pseudoephedrine as a more effective alternative for cold and sinus relief. However, due to its potential for misuse, pseudoephedrine can only be purchased with a state-issued ID from behind the pharmacy counter.
What are the potential implications of the FDA’s proposal to remove phenylephrine from over-the-counter cold medicines?
## Is Popular Cold Medicine Ingredient Heading for the Shelf?
**Anchor:** Welcome back to the show. We’re diving into a controversial topic today: the potential removal of a common cold medicine ingredient. Joining me to break down the FDA’s recent proposal is Dr. Aaron Stone, a pharmacist with Valley Health. Dr. Stone, thanks for being here.
**Dr. Stone:** Thanks for having me.
**Anchor:** Let’s get right to it. The FDA is proposing to remove oral phenylephrine from over-the-counter cold medications. Why?
**Dr. Stone:** The main reason cited by the FDA is lack of efficacy. Phenylephrine is designed to be a nasal decongestant, meaning it’s supposed to relieve stuffy noses. But recent studies suggest it may not actually work as intended [[1](https://www.fda.gov/news-events/press-announcements/fda-proposes-ending-use-oral-phenylephrine-otc-monograph-nasal-decongestant-active-ingredient-after)].
**Anchor:** So it’s basically just not effective?
**Dr. Stone:** That’s the concern. While the mechanism behind phenylephrine, which is to constrict blood vessels, makes sense on paper, the evidence just isn’t there to support its effectiveness in relieving nasal congestion.
**Anchor:** Are there any other concerns surrounding this ingredient?
**Dr. Stone:** Yes, there are also potential safety concerns. Being a vasoconstrictor, phenylephrine can tighten blood vessels, which could pose risks for certain individuals.
**Anchor:** This is obviously a big deal for consumers who rely on these medications. What are the potential implications of this proposal?
**Dr. Stone:** It means we might see a shift towards other decongestants, possibly those that are available by prescription only. It also highlights the importance of staying informed about the medications we use and understanding their effectiveness and potential risks.
**Anchor:** Dr. Stone, thank you for shedding light on this important issue. We’ll be following this story closely as it develops.
