Last fall I wrote a nasty article chiding the FDA for its delayed action against cold, cough and allergy pills containing the phenylephrine decongestant. That’s because I had written about this problem 50 years ago in my first book, The People’s Pharmacy (St. Martin’s Press).
My exact words about the oral phenylephrine decongestant:
“Though it might work if given in a sufficient dose (more than forty milligrams), most nonprescription cold medications have less than half that amount. According to Consumer Reports, ‘the oral dose in two Dristan tablets is only one-fourth of the dosage found to be ineffective in controlled clinical testing.”
The FDA was aware in 2007 that only about 1% of an oral dose of the phenylephrine decongestant is absorbed from the digestive tract. A CITIZENS PETITION from from three pharmacy professors at the University of Florida was submitted to the FDA on February 1, 2007.
It stated in part:
“…we concluded that phenylephrine is unlikely to relieve nasal stuffiness at the maximum FDA approved dose of 10 mg.”
“A recently published literature review and a Cochrane Review similarly concluded that phenylephrine was not effective orally while there was support for the efficacy of this drug when administered as a topical nasal solution.”
It was exactly that last point that led a reader to object to my article: “Is Phenylephrine a Worthless Decongestant?”
Even though I thought I was very clear that the ORAL phenylephrine decongestant was the problem, this reader took exception.
The Topical Phenylephrine Decongestant DOES Work:
Q. I just read your article about the ineffectiveness of phenylephrine as a nasal decongestant. There is an important distinction regarding phenylephrine products, though.
Nasal sprays containing phenylephrine do work! You can find it under the brand name Neo-Synephrine. I have no doubt about its effectiveness applied topically, because if I use the full-strength nasal spray for a week, I get rebound congestion when it wears off.
Since I have elevated blood pressure as well as allergies, I use phenylephrine at a greatly reduced concentration. I take a 1-ounce bottle and dilute it with sterile saline to 10 to 12 ounces total. It still works, but there’s much less rebound congestion. The same mixture works to get off of the 12-hour nasal sprays sold for severe stuffiness. Those usually cause significant rebound congestion if used for more than three days.
I don’t take oral forms of any decongestant as I don’t want to raise my blood pressure. This is why I would oppose any effort to ban phenylephrine totally from nasal spray or drops.
Not the only reader to point out that topical phenylephrine works!
Q. The oral decongestant phenylephrine never worked for me. But as a nasal spray it’s helpful, and it’s also effective for local application in hemorrhoid products.
I have used pseudoephedrine for years when my ears are plugged due to congestion. It elevates my blood pressure mildly, but nothing severe
We responded to both readers:
A. Thank you for pointing out the difference between phenylephrine (PE) tablets and nasal sprays. The FDA recently acknowledged that the oral version of this decongestant is poorly absorbed and is probably ineffective. There are over 250 PE-containing products on pharmacy shelves and Americans spend more than $1.7 billion on such cold and allergy pills. Some experts estimate that Americans have purchased nearly 20 billion PE-containing products over the last decade or so.
As far as we can tell, the FDA has not yet taken action to request the removal of cold remedies containing PE. That would create a giant nightmare for pharmacies, grocery stores, airport kiosks and convenience stores. Many of the most popular cold and allergy brands would disappear overnight. The FDA would be left with a lot of egg on its face.
The topical version of PE found in nasal sprays does not have to be absorbed through the stomach. It has direct vasoconstrictor action in the nose. PE also can cause constriction of blood vessels in the eyes or the rear end when applied topically. If used for more than a few days, though, there may be a concern about rebound congestion if the product is stopped suddenly.
Oral pseudoephedrine (Sudafed) is effective as a decongestant, but it is available only behind the pharmacy counter.
How to Beat Nose Spray Dependence:
Nasal decongestants containing ingredients such as phenylephrine, oxymetazoline and xylometazoline are very effective when sprayed into the nose. They constrict blood vessels (vasoconstriction) on contact. These topical products have a downside, though. Doctors call it rhinitis medicamentosa. It means drug-induced inflammation of the nasal tissues.
As our reader so thoughtfully pointed out, when used for more than three days, nasal sprays can lead to rebound nasal congestion. It can be as bad or worse than the original stuffy nose. To learn how to overcome nose spray dependence, check out our article at this link.
Hemorrhoid Remedies and High Blood Pressure!
Why, you might wonder, would we be writing about hemorrhoid remedies when this is an article about a phenylephrine decongestant? Well, products like Preparation H Hemorrhoidal Suppositories also contain phenylephrine (PE). Because PE is a vasoconstrictor, it “shrinks hemorrhoidal tissue.”
But there can be a complication for some people. A few years ago, we received this message from a reader.
“After using Preparation H for several days, my blood pressure went to 206 over 98 and I ended up in the emergency department for hours. I never had high blood pressure before in my life. It is always around 130 over 65.”
More recently we received another case report and wrote it up here:
Did Anal Absorption of Prep H Raise BP?
The person who contacted us reported that her blood pressure climbed 16 points. She wondered whether Preparation H could have been responsible.
You may find an old Prep H TV commercial amusing. It advertises “oxygen action.” There is also an entertaining conversation between Bryan Cranston and Jimmy Fallon about Preparation H and its “oxygen action.” Get to it at this link.
Final Words:
So, here is the dilemma. The FDA finally admits that the oral phenylephrine decongestant does not work to ease nasal congestion. And yet it has been sold for over 75 years. We wrote about questions of efficacy more than 50 years ago. Nevertheless, the Food and Drug Administration has allowed hundreds of familiar brands to market this ingredient to millions of people for many decades. Billions of dollars have been spent on OTC cold, cough and allergy meds.
There are no OTC drug products that speed healing from the common cold. And questions have been raised about the benefits of fever reducers (antipyretics). Some scientists believe that cold and flu preparations that reduce a mild to moderate fever may be counterproductive. You can read about this paradox at this link.
So, if the oral nasal decongestant phenylephrine does not work and if antipyretics could be problematic, why is the FDA allowing such products to be sold over the counter?
We are not even going to get into the question that has been raised regarding the effectiveness of dextromethorphan (DM), a widely used cough suppressant.
To tickle your curiosity, though, here is a quote from the Journal of Pharmacy and Pharmacology, Oct. 2000:
“Dextromethorphan is one of the most widely used antitussives [cough suppressants] for the treatment of cough associated with acute upper respiratory tract infection. However, there is very little data to support the efficacy of dextromethorphan in this disease state…This study provides very little if any support for clinically significant antitussive activity of a single 30 mg dose of dextromethorphan in patients with cough associated with acute upper respiratory tract infection.”
The bottom line is that the FDA has stated that the products it permits on the market are both safe and effective. Hmmmm. We have long had doubts about that the truth of this concept. Just watch any pharmaceutical ad on TV to learn about drug side effects such as heart attacks, strokes, kidney failure, cancer and death, the ultimate adverse drug reaction!
The topical nose sprays that contain PE do work, but you can only use them for a few days or risk rebound nasal congestion after discontinuing the spritzing. And hemorrhoid remedies that contain phenylephrine may raise blood pressure in susceptible individuals.
If you think this information is of interest to friends or family, please share it by scrolling to the top of the page and clicking on the icons for email, Twitter or Facebook. If you have used a phenylephrine decongestant orally or topically, please take a moment to add your story in the comment section below.
And if you would like to learn about nondrug approaches for colds, coughs & the Flu, check out our eGuide. These home remedies and natural products may not have been approved by the FDA, but a lot of readers believe they work without some of the complications of FDA-approved medications.
