Phenylephrine: This Deadly Snake Oil Can't Replace Sudafed

Several weeks ago, while desperately attempting to ward off congestion in my ears and sinuses, I purchased a package of pseudoephedrine--better known by the brand name Sudafed--at my local pharmacy. Twenty years ago, a person could have purchased Sudafed (and ephedra, the traditional Chinese herb containing the compound) with little or no hassle. Instead, I had to show my driver's license, write my name and address on a list, and explain to the pharmacist why I was buying it. As I turned to leave the store, the pharmacist said to me, "You're ruining your life."

It's impossible to buy pseudoephedrine in 2011 without being treated like a criminal. Thanks to the low-life dirtbags who use the product to manufacture methamphetamine, Sudafed itself is now viewed as a harsh drug-- not as an effective medicine. Today, almost all Americans turn to its hassle-free cousin, phenylephrine, as an alternative. Almost all decongestants sold today contain phenylephrine as a substitute for pseudoephedrine. But there's one major problem with this now-popular alternative: it doesn't work.

The End of Sudafed's Reign

For over a decade, phenylephrine has been gradually gaining pace as the world's dominant over-the-counter decongestant. If you scan the shelves of your local pharmacy, you'll notice that nearly every single product marketed with the word "decongestant" contains phenylephrine as its sole or primary ingredient. Just a few short years ago, pseudoephedrine dominated the market as a method for reducing nasal and sinus congestion.

Pseudoephedrine is a naturally occurring compound found most notably in the leaves of the ma huang, or ephedra, plant. In traditional Chinese medicine, ma huang was used to treat asthma, colds, coughs, pneumonia, and sinusitis. It worked splendidly due to its high concentration of pseudoephedrine and its chemical cousin ephedrine--both of which were eventually synthesized and sold as pharmaceutical drugs.

Unfortunately, human nature kicked in and caused ma huang, pseudoephedrine, and ephedrine to all gain reputations as highly toxic, easily abused drugs. Ma huang was marketed without FDA approval as a weight loss aid, and several people died as a result of its side effects. This prompted an FDA recall of all supplements containing the herb.

Synthetic ephedrine and pseudoephedrine have also been widely abused, both by desperate dieters and by people using them to manufacture methamphetamine. Thanks to the Combat Methamphetamine Epidemic Act of 2005, classic Sudafed and all of its relatives have been placed under lock and key behind pharmacy counters.
The rise of phenylephrine began in the wake of these disasters.

Phenylephrine Takes Over

U.S. Food and Drug Administration first approved phenylephrine in 1976, although only weak science supported its use. The FDA still stands by the product's efficacy as a nasal and sinus decongestant, but its efficacy remains a point of much debate.

Phenylephrine was not a particularly popular medication until the the early 2000s, when fears regarding ma huang--its natural precursor--and methamphetamine--its deadly chemical offspring--began to peak. In the late 90s and early 2000s, a few manufacturers began offering new "PE," or phenylephrine, versions of products that formerly contained pseudoephedrine. This gave customers the idea that they were purchasing a novel product that would be inherently safer than the increasingly notorious pseudoephedrine.

In 2004, drug manufacturers were informed of impending legislation, the Combat Methamphetamine Epidemic Act of 2005. This ordered strict restrictions on the sale of products containing pseudoephedrine. Although it may have helped to slow the production of methamphetamine, pharmaceutical companies were terrified that it might affect sales of their products. Almost all manufacturers responded to the restrictions by replacing pseudoephedrine with phenylephrine as the "active" ingredient in their products.

... But it Doesn't Work

There is no compelling evidence that phenylephrine actually works at the dose recommended on over-the-counter product labels. According to a press release by the University of Florida, the FDA based its approval of phenylephrine on only four limited tests. Half of these trials were not peer-reviewed, and they were paid for by the manufacturers of the drugs.

By contrast, six very well-designed studies have found that phenylephrine works no better than a placebo at relieving nasal stuffiness from colds, flu, allergies or sinusitis. If we stick with unbiased science, we see two studies supporting phenylephrine and six studies disproving it. So far, the evidence is pretty clear that phenylephrine is ineffective.

Many phenylephrine users will anecdotally report success using the product. I myself had taken it and believed that it worked, at one point. But, as we all know, correlation does not imply causation. As far as science shows us, the odds of finding congestion relief from phenylephrine are the same as finding relief from an inert sugar pill-- except that the placebo isn't likely to cause serious side effects.

How Phenylephrine can Kill

To be fair, phenylephrine is safer than classic Sudafed--and that is part of the reason for its success. But, unfortunately, phenylephrine users can pay a deadly price without gaining any real benefit from the product. Several people, including young children, have died after using phenylephrine products that we presume to be safe. The risks are not worth the benefits, considering that there is no convincing evidence that it offers any real benefits to speak of.

The National Institutes of Health notes that phenylephrine's most common symptoms are anxiety, insomnia and dizziness-- similar, perhaps, to having a few too many cups of coffee. For high-risk individuals such as those with hypertension, it can cause a serious cardiovascular problem, up to and including a heart attack.

Phenylephrine's dangers are most serious for young children--in fact, USA Today reported that at least 54 American children have died from the use of phenylephrine, pseudoephedrine and ephedrine.The American Academy of Pediatrics strongly warns against the use of cold medicines containing phenylephrine, asking parents to give them only to children over the age of six, and only with a physician's approval.

Knowing this, I can't give phenylephrine to myself or to my three-year-old daughter in good conscience. Due to my own medical conditions, I am supposed to use Sudafed cautiously, if at all--but I am not going to sit down and swallow a phenylephrine pill simply because the pharmaceutical industry claims that it works. Even as the pharmacist--assuming me to be a drug manufacturer--tells me that I'm ruining my life, I'll keep buying my old-fashioned Sudafed when my doctor okays it. At the end of the day, I value real medicine over pharmaceutical quackery.

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