The Ineffectiveness of Phenylephrine: America’s Expensive Cold and Flu Mistake
You wake up with a stuffy nose, so naturally, you head to the pharmacy to find relief. In the cold-and-flu aisle, you’re presented with a plethora of options. Ah, the convenience of living in 21st-century America! There’s Sudafed PE, promising “maximum-strength sinus pressure and nasal congestion relief.” Sounds great. Or perhaps DayQuil would be a good choice, just in case other symptoms arise. Tylenol Cold + Flu Severe is always an option if things get really bad. And what if it’s allergies? Good thing there’s Benadryl Allergy Plus Congestion.
Unfortunately, for you, me, and everyone else in this country, the decongestant in all of these pills and syrups is entirely ineffective. Despite the different brand names, the active ingredient, phenylephrine, fails to address congestion. Roughly two decades ago, oral phenylephrine began appearing on pharmacy shelves, despite mounting evidence that it simply does not work.
“It has been an open secret among pharmacists,” says Randy Hatton, a pharmacy professor at the University of Florida, who has petitioned the FDA multiple times to reconsider phenylephrine. Finally, this week, an advisory panel voted 16-0 that the drug is ineffective when taken orally, potentially leading to its removal from the market.
If this happens, the impact would be significant. Phenylephrine is a component of many popular multidrug products, such as DayQuil, which Americans collectively spend $1.763 billion per year on, according to the FDA. This is a staggering amount of money for a decongestant that, once again, does not work.
Before the rise of oral phenylephrine, over-the-counter decongestants were not this ineffective. However, in the early 2000s, access to pseudoephedrine, an effective decongestant, became restricted due to its potential for meth production. The Combat Methamphetamine Epidemic Act of 2006 made these restrictions national. Although you can still purchase Sudafed containing pseudoephedrine, you must show ID and sign a logbook. Meanwhile, manufacturers flooded the shelves with phenylephrine replacements, like Sudafed PE. It’s easy to see why consumers may not have noticed the switch from pseudoephedrine to phenylephrine.
“The switch from pseudoephedrine to phenylephrine was a big mistake,” says Ronald Eccles, former head of the Common Cold Unit at Cardiff University. Eccles criticized the switch as early as 2006. The evidence at that time was already indicating that phenylephrine was an ineffective oral drug.
The issues with phenylephrine surfaced quickly. Randy Hatton, along with colleagues at the University of Florida, began receiving numerous questions about its effectiveness. Patients complained that it did nothing for their congestion. Hatton decided to investigate further and filed a Freedom of Information Act request to obtain the data behind the FDA’s 1976 evaluation of the drug. He discovered that the 14 studies considered by the FDA had mixed results. Suspiciously, the positive studies were all conducted at the same research center. Upon excluding those questionable studies, the drug no longer appeared effective at its usual dose.
The case for phenylephrine was weak, but the case against it was not definitive. When Hatton and his team filed a citizen petition, they asked the FDA to explore higher doses that may be more effective, rather than completely pulling the drug from the market.
Further damning evidence emerged after the petition led to an FDA advisory committee meeting in 2007. Scientists from the pharmaceutical company Schering-Plough (now Merck) presented new data that dismantled phenylephrine’s supposed efficacy. They showed that very little phenylephrine reaches the nasal passages, where it could reduce congestion and swelling by constricting blood vessels. When taken orally, most of it gets destroyed in the gut, with only 1 percent being active in the bloodstream. This supported the experiences of people who took the drug and felt no relief. Additional studies demonstrated that phenylephrine was no better than a placebo for people with pollen allergies.
These studies were significant, prompting the FDA to reassess how oral phenylephrine works in the body. However, experts were still not ready to dismiss the drug entirely. The 2007 meeting concluded with the advisory committee requesting data on higher doses.
Subsequent studies conducted by Merck showed that increasing the dose did not yield any benefits. Phenylephrine was ineffective even at four times the labeled dosage of 10 milligrams every four hours. This prompted Hatton and his colleagues to file a second citizen petition, leading to the recent advisory panel meeting. During the meeting, one committee member stated that the drug simply does not work, and the panel voted 16-0 in agreement. However, the FDA has the final say on whether phenylephrine will be removed from the market.
This isn’t the only cold-and-flu drug with questionable efficacy in its approved form. Guaifenesin and dextromethorphan, common cough drugs, have also faced scrutiny. However, there isn’t enough clinical-trial data to reach a definitive conclusion about them. Hatton believes that the fact that Merck funded these studies helped strengthen their case against phenylephrine. Typically, failed studies from pharmaceutical companies go unpublished. Hatton hopes for public funding of trials like Merck’s to evaluate other over-the-counter drugs.
There are other effective decongestants available. Although phenylephrine is ineffective when taken orally, it is very effective when sprayed into the nose. Neo-Synephrine is one such phenylephrine nasal spray. There are also nasal sprays containing other decongestants, like Afrin. However, the only other common oral decongestant is pseudoephedrine, which requires an additional step of asking the pharmacist for it.
Unfortunately, restricting pseudoephedrine has not curbed the meth epidemic. Meth-related overdoses have skyrocketed as Mexican drug rings developed new, cheap methods of meth production without using pseudoephedrine at all. While an effective drug remains behind the counter, ineffective alternatives fill the shelves.
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