If you’ve had a sneaking suspicion that those decongestant medicines you’ve been taking aren’t really doing much, you’re probably right. At least according to an advisory panel reporting to the Food and Drug Administration (FDA), which states that the main ingredient in many over-the-counter decongestants, phenylephrine, is ineffective and doesn’t perform better than placebo.
If the agency decides to ban the ingredient, it could mean that Sudafed P.E., NyQuil Severe Cold & Flu and Tylenol Cold & Flu Severe and other cold and flu remedies for both kids and adults could be pulled from shelves while manufacturers reformulate, making flu season that much more complicated. Here are our best recommendations on what to do or take instead.
A panel of experts advising the FDA unanimously agreed that oral phenylephrine in OTC nasal decongestants is not effective at relieving symptoms. While it can still be useful in nasal spray formulations (like Afrin), the panel determined that phenylephrine is destroyed in the gut when ingested orally, which means it never gets to the intended target location of constricting blood vessels in nasal passages to reduce congestion—and doesn’t actually work.
The drug is not considered a safety risk, but several advisers noted that patients taking the drug were merely delaying their journey to a useful remedy, The New York Times reports.
“I think we clearly have better options in the over-the-counter space to help our patients, and the studies do not support that this is an effective drug,” said Maria Coyle, the chairwoman of the panel and an associate professor of pharmacy at Ohio State University.
The FDA has yet to decide whether to ban phenylephrine, and it could be a while until they do so. Some medications containing phenylephrine have other active ingredients, like expectorants to loosen mucus, that have been shown to be effective. But you may still want to look for alternative options.
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“Me, personally, I wouldn’t want myself or my kid to take anything that’s unnecessary and that’s demonstrated ineffective,” said Jennifer Le, a member of the advisory committee and a professor of clinical pharmacy with the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California, San Diego, to The Times.
For adults, pseudoephedrine (commonly sold as Sudafed) has been shown to be effective at reducing nasal congestion, but it’s not safe for kids under 6, and may come with some side effects, like an increase in blood pressure or rapid heart rate. Pseudoephedrine is considered a restricted OTC, so it’s only available from a pharmacist behind the counter.
If your stuffiness is related to allergies, oral antihistamines like Zyrtec, Allegra and Claritin may help, or a nasal steroid spray like Flonase. (Before using any allergy medications in kids, consult with their pediatrician.)
Cold medications for kids formulated without phenylephrine include multi-symptom products that tackle cough and congestion with cough suppressants (like dextromethorphan HBr) and expectorants (like guaifenesin) to help loosen sticky mucus.
Cold medicines are typically used for symptom management and temporary relief and don’t get to the root of the issue, but they may allow both adults and kids to get better rest. They aren’t without side effects, however.
It’s worth noting that having a cold doesn’t necessarily mean you or your child needs cold medicine. In many cases, colds need to run their course, but if the virus turns into a sinus or ear infection, reach out to your primary care provider or your child’s pediatrician for best next steps.
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