The FDA Finally Admits That the Most Popular Oral Decongestant Doesn’t Work

When pseudoephedrine was banned from over-the-counter sales in 2006 (it’s still available “over the counter” but kept behind the counter), Sudafed and other companies had to come up with a way to keep something available for easy purchase. That’s why Sudafed PE, a completely different and supposedly ineffective product, is one you can easily take with you when you’re running late at night to get cold medicine. Its active ingredient, phenylephrine, dominates the cold medicine market.

But this week , an FDA advisory panel ruled that phenylephrine should no longer be considered an effective drug , meaning it could eventually be pulled from the market.

What is the difference between Sudafed and Sudafed PE?

Sudafed contains pseudoephedrine, which is widely known to work well as a decongestant. (The brand name itself is a shortened version of the drug’s name.)

Sudafed PE uses a completely different ingredient: phenylephrine. This is the one that the FDA panel says doesn’t work . It never worked. The only reason you bought Sudafed PE is because you were looking for Sudafed and decided that this was it.

Phenylephrine is not only found in Sudafed PE. In fact, it is the most popular oral decongestant (oral means it is taken in tablet or syrup form). Some other over-the-counter medications that use phenylephrine include:

• Tylenol: Runny Nose and Headache, Tylenol: Severe Sinusitis, Tylenol for Colds and Flu, Tylenol for Colds and Severe Flu, Tylenol for Runny Nose and Severe Congestion
• Theraflu for severe cold relief, Theraflu ExpressMax, Theraflu Multi-symptom relief for severe colds
• Mucinex FastMax, Mucinex Night Shift, Mucinex SinusMax,
• Alka-Seltzer Plus Cold and Flu (Day and Night Formulas), Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz
• DayQuil, NyQuil for Severe Colds and Flu, Nyquil for Severe Colds and Flu, Honey, DayQuil for Severe Colds and Flu

This isn’t a complete list, but if you read it and think, “Well, that’s pretty much every cold medicine that says it will relieve your stuffy nose,” that’s about right. If you need effective cold medicine, you will need to show your ID and get pseudoephedrine.

What is the difference between phenylephrine and pseudoephedrine?

Both are sold and (currently) approved by the FDA as over-the-counter decongestants. In short: pseudoephedrine does a good job, but there are restrictions on how you can purchase it. Phenylephrine is more widely available but does not do its job very well.

Pseudoephedrine is the active ingredient in original Sudafed and constricts blood vessels. This cold medicine helps relieve nasal congestion. It is called pseudoephedrine because it is related to the stimulant ephedrine , such as ephedra (ma huang). It’s also chemically similar enough to methamphetamine that it can be used as an ingredient to make meth… which is why you can’t buy unlimited amounts of it at the pharmacy. Since 2006, federal law has required that pseudoephedrine be kept out of the reach of consumers. Pharmacists must keep records of who has purchased pseudoephedrine, and you are limited in how much you can buy in one day and per month.

Phenylephrine is also supposed to constrict blood vessels, relieving nasal congestion, but studies show that it breaks down in the body and virtually no active ingredient ever gets into the nose (unless you take phenylephrine as a nasal spray ). When the sale of pseudoephedrine was restricted, cold medicine manufacturers began producing substitutes containing phenylephrine. And they were right to bet on them, at least financially: if you don’t know that good Sudafed is behind the counter (or if it’s late and the pharmacist has gone home), you’ll buy Sudafed PE and decide it’s the best . the same. Is not.

How can they sell a cold medicine that doesn’t work?

This is a good question, and one that doctors and scientists have been asking for years. For example, here is an article from the Annals of Pharmacotherapy entitled “Why was oral phenylephrine brought to market after strong evidence of its ineffectiveness as a decongestant?”

The FDA considered removing phenylephrine from the market in 2007, but ultimately decided it could be kept until more research was done. One possibility was to test higher doses of the drug. At a recent meeting, an FDA panel decided it was unsafe; large doses can affect people’s blood pressure.

If you’re interested in the science behind the finding that phenylephrine is ineffective, you can read the white paper that FDA panelists reviewed before the vote. It points out flaws in earlier studies that suggested the drug works and includes results from placebo-controlled trials that show phenylephrine does not work any better than pills that contain no drug at all.

The paper also argues that you and I would be better off if we didn’t spend money on a drug that doesn’t do anything (and that might have side effects or that we might be allergic to, which is always a risk with any drug). . ).

What should I do if my favorite cold medicine goes off the market?

First of all, it doesn’t happen overnight. The FDA has not yet decided what it will do with its advisory panel’s verdict. (It knows drug makers won’t be happy about this.)

But if you’re in the habit of buying one of the products that contains phenylephrine, and if that product does get discontinued, you’ll essentially find yourself in the same situation we’re all in now: having to find other decongestants or go without. As we’ve explained before , the best cold medications are over-the-counter pseudoephedrine for nasal congestion, grocery store honey for coughs, and regular acetaminophen or ibuprofen for fever and body aches. (Please do not buy homeopathic cold remedies; they are not what you think .)

However, there are other ways to treat nasal congestion besides pseudoephedrine. If nasal congestion is due to allergies, antihistamines may help. Phenylephrine nasal spray probably works and is here to stay. And don’t forget that you can always talk to your doctor or even your pharmacist at your local pharmacy to learn about other options.