A Common Nasal Decongestant Doesn’t Actually Work. What Should You Use Instead?
Nasal and sinus expert says there are far better and safer alternatives than phenylephrine that are available over the counter
An advisory panel to the US Food and Drug Administration (FDA) has unanimously agreed that a common ingredient found in nasal decongestants, called phenylephrine, is a dud. The panel said that the popular medicine is ineffective when taken orally—no better than a sugar pill.
The news could have a big impact on your medicine cabinet. Phenylephrine is in at least 250 products that were collectively worth about $1.8 billion in sales last year, including cold, flu, and allergy products from brands like Tylenol, Mucinex, Benadryl, Sudafed, NyQuil, and others. Now that the panel has voted, the FDA has to decide whether or not to ban the ingredient, which would involve pulling products from store shelves.
Phenylephrine has been available for over 60 years, which means it didn’t undergo the rigorous scrutiny applied to newer medicines. When the FDA toughened its approach in the 1970s, the ingredient was basically grandfathered into the agency’s new drug approval list. But modern studies have found that taking the medication orally is no more effective than a placebo.
So, why has this decongestant been available for so many decades, despite experts questioning its effectiveness? And what should people searching for ways to relieve a stuffy nose do? Nasal and sinus researcher and physician Michael Platt, a Boston University Chobanian & Avedisian School of Medicine associate professor of otolaryngology–head and neck surgery, spoke with The Brink about what this news means for doctors and consumers.
with Michael Platt
The Brink: Was this news of phenylephrine being ineffective surprising to you?
Platt: This medication, phenylephrine, is lumped into the category of a decongestant. If you go back and look at guidelines from decades ago, there was no evidence that it worked, so this decision isn’t a surprise. I don’t think I’ve recommended this product over the past 15 years in practice. But it raises questions [of] how something like this could happen, when you look back at the history of drug approvals and how long it takes to change things that have been approved.
The Brink: If this ingredient doesn’t work, why have these products been available for so long?
Platt: Phenylephrine is effective topically as a decongestant, so as a nasal spray. And there’s not many decongestants available over the counter. We have pseudoephedrine, which works, but is now only [available] behind the counter due to the potential to be misused. We also have oxymetazoline, which is the main ingredient in Afrin. So, phenylephrine filled a need to have medicine that was more easily accessible. But if you go back and look at the data, studies about this drug were all industry-sponsored studies, which always have some inherent bias in them. Clearly the data was not strong.
The Brink: So, I’m assuming the topical products won’t be affected?
Platt: That’s correct. Topical decongestants are really only appropriate for short-term use. If you use them long-term, you get worse problems. Many people get addicted to them, and they don’t treat the underlying disease process. For chronic disorders, including nasal allergies, seasonal allergies, I don’t recommend decongestants for those patients. There are better medications, like antihistamines, which are available both topically and systemically. There’s nasal steroid sprays that work really well, and are safe.
The Brink: So, you’re not worried about a shortage of products if some have to come off the shelves?
Platt: No, there are much better options. I think it’ll be a good thing if oral phenylephrine products come off the shelf since they don’t work and have side effects that could cause harm. Steering patients toward safer, better alternatives would definitely be a win for everyone. Patients can easily get into the habit of putting a band-aid on the problem—they have congestion, therefore think they need a decongestant. The next thing you know, they’re using it chronically when they shouldn’t be. Congestion is a very generic symptom, and it can be due to diseases that are sometimes not serious, but there are also serious diseases that occur in the nose that can present with congestion. It’s important to understand what you’re actually treating.
The Brink: How do decongestants work?
Platt: They stimulate the autonomic nervous system to give you a response similar to adrenaline or epinephrine, which constricts blood vessels. So, in your nose, you’re shrinking the blood vessels and decreasing the blood supply into the nose. Structures in the nose, called turbinates, swell up when you get a cold or allergies. They’re like round balls of tissue in your nose, and they fill up with blood and get swollen, and when you take a decongestant, it shrinks those blood vessels. It also makes your blood pressure go up, just like adrenaline does.
The Brink: What would your general advice be for people searching for an effective over-the-counter product for a cold?
Platt: If it’s a short-term need for a decongestant, I prefer topical decongestants that you spray in your nose, and topical antihistamine sprays that don’t have those same side effects on blood pressure and are accessible. It’s important to know what you’re treating, and primary care doctors can make diagnoses, and when they can’t, they send patients to rhinologists like me or allergists/immunologists. We all often work together to get the right diagnosis, and then the best treatment plan.
The Brink: What do you think will happen now that it’s up to the FDA?
Platt: I can’t see how the FDA would ignore this type of recommendation and ignore the data. The FDA follows the science and I don’t see how they’re not going to remove these products. I think patients will seek better alternatives that are more effective and safer.