FDA Finally Admits the Most Popular Oral Decongestant Doesn't Work - Lifehacker

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When pseudoephedrine was banned from off-the-shelf sale 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—an entirely different, and allegedly ineffective, product—is the one you can easily grab when you're making a late night run for cold medicine. Its active ingredient, phenylephrine, dominates the cold medicine aisle.

But this week, an FDA advisory panel ruled that phenylephrine should no longer be considered an effective drug—which means it could end up being pulled from the market.

What is the difference between Sudafed and Sudafed PE?

Sudafed contains pseudoephedrine, which is widely understood 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. That's the one that, according to the FDA panel, doesn't work. It has never worked. The only reason you bought Sudafed PE is because you were looking for Sudafed and figured this was it.

Phenylephrine isn't just in Sudafed PE. It's actually the most popular oral decongestant (oral meaning that it's given as a pill or syrup). Some other over-the-counter medicines that use phenylephrine include:

• Tylenol Sinus & Headache, Tylenol Sinus Severe, Tylenol Cold & Flu, Tylenol Cold & Flu Severe, Tylenol Cold & Head Congestion Severe

• Theraflu Severe Cold Relief, Theraflu ExpressMax, Theraflu Multi-Symptom Severe Cold

• Mucinex FastMax, Mucinex NightShift, Mucinex SinusMax,

• Alka-Seltzer Plus Cold and Flu (both Day and Night formulas), Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz

• DayQuil, NyQuil Severe Cold & Flu, Nyquil Severe Cold & Flu Honey, DayQuil Severe Cold & Flu Honey

This isn't a complete list, but if you're reading it thinking "well, that's pretty much every cold medicine that says it will relieve your stuffy nose," that's about right. If you want a cold medicine that works, you'll need to show your ID and get the pseudoephedrine.

What is the difference between phenylephrine and pseudoephedrine?

Both are sold and (for the moment) FDA-approved as over-the-counter decongestants. In brief: pseudoephedrine works well at its job, but there are restrictions on purchasing it. Phenylephrine is more widely available, but does not work well at its job.

Pseudoephedrine is the active ingredient in original Sudafed, and it constricts blood vessels. As a cold medicine, this allows it to reduce congestion in your nose. It's called pseudoephedrine because it's related to the stimulant ephedrine, as in ephedra (ma huang). It's also chemically similar enough to methamphetamine that you can use it as an ingredient for making meth...which is why you can't buy unlimited amounts of it at the pharmacy. Since 2006, federal law has required pseudoephedrine to be kept out of reach of customers. Pharmacists must make a record of who has bought pseudoephedrine, and you're limited in how much you can buy in a single day and in a month.

Phenylephrine is also supposed to be able to constrict blood vessels to relieve congestion, but studies show it breaks down in the body, and little to none of the active ingredient ever makes it to your nose (unless you take phenylephrine as a nasal spray). When pseudoephedrine's sale was restricted, cold medicine manufacturers made phenylephrine-containing replacements. And they were right to bet on them, financially at least: If you don't know that the good Sudafed is behind the counter (or if it's late and the pharmacist has gone home), you'll buy Sudafed PE and figure it's the same thing. It is not.

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

That's a good question, and it's one that doctors and scientists have been asking for years. For example, here's a paper from the Annals of Pharmacotherapy titled "Why Is Oral Phenylephrine on the Market After Compelling Evidence of Its Ineffectiveness as a Decongestant?"

The FDA considered taking phenylephrine off the market in 2007, but ultimately decided it could stay while more research was done. One possibility was to test larger doses of the drug. In the more recent meeting, the FDA panel decided that would be unsafe; large doses can affect people's blood pressure.

If you're curious about the scientific basis for the conclusion that phenylephrine doesn't work, you can read the briefing document that the FDA panelists considered before voting. It points out flaws in older studies that had suggested the drug works, and it includes results from placebo-controlled trials that show phenylephrine doesn't work any better than a pill containing no drug at all.

The document also makes the case that you and I will be better off if we're not wasting our money on a drug that does nothing (and that may have side effects or that we might be allergic to, which are always risks with any drug).

What should I do if my favorite cold medicine gets pulled from the market?

First off, this isn't happening overnight. The FDA has not yet made a ruling on what it will do with its advisory panel's verdict. (It knows that drug manufacturers will not be happy about it.)

But if you're used to buying one of the products that contains phenylephrine, and if that product does get pulled, you'll basically be in the same situation we are all in now: having to look for other decongestants, or go without. As we've explained before, the best cold medicines are the pseudoephedrine behind the counter for congestion, the honey in the grocery aisle for cough, and regular acetaminophen or ibuprofen for fevers and body aches. (Please do not buy homeopathic cold medicines; they aren't what you think they are.)

That said, there are other ways to treat congestion besides pseudoephedrine. If your congestion is allergy-related, antihistamines can help. Phenylephrine in a nasal spray probably works, and isn't going anywhere. And don't forget that you can always talk to your doctor, or even the pharmacist at the drugstore, to ask about other options.

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