Cold and flu season is in full swing and is a bad time for consumers to learn that some of their most trusted go-to products don’t actually work.
advisory committee US Food and Drug Administration Phenylephrine is the active ingredient in common over-the-counter cough and cold medicines such as Sudafed PE, Theraflu, and NyQuil Severe Cold and Flu, and is said to be as effective as a placebo when taken orally, according to September 2023. was unanimously concluded. The 2023 FDA Advisory Committee met to consider the growing evidence that oral phenylephrine is ineffective as a treatment for nasal congestion. The committee did not consider the effectiveness of phenylephrine nasal spray.
In response, CVS, one of the largest pharmacy chains in the United States, We no longer sell products Products containing oral phenylephrine as the only active ingredient at your local pharmacy.
The committee’s decision may come as a surprise to the millions of Americans who suffer from nasal congestion and colds this fall and winter, many of whom have been using products containing phenylephrine for years.
Consumers are probably wondering whether they should stop using over-the-counter products containing phenylephrine, whether they will still be on shelves this winter, and what other options they have. Consumers may also wonder whether combination cough, cold, and flu products are safe and effective for use at home.
As the FDA considers the advisory committee’s conclusions, oral phenylephrine remains widely available in many pharmacies, despite the fact that more effective over-the-counter medications and non-pharmacological approaches exist to relieve congestion. likely to be sold at.
as a pharmacist a person who concentrates on Patient care in the communityhere are some tips if you need relief from cold or flu symptoms.
inside story
As of fall 2023, phenylephrine is listed as the only active ingredient or one of the active ingredients in thousands of over-the-counter products, including tablets, liquids, nasal sprays, gels, and ointments.
This drug has long been used to temporarily relieve symptoms when taken as an oral tablet, oral solution, or nasal spray. sinus or nasal congestion Due to a cold or seasonal allergies. Phenylephrine is the only oral nasal decongestant on pharmacy and grocery store shelves since another popular nasal decongestant. pseudoephedrineregulations become stricter, I went behind the counter in 2006..
The latest analysis is not the first time oral phenylephrine has been scrutinized by an FDA advisory committee.A 2007 panel examining its use concluded that further research is needed To make a final decision on the effectiveness of phenylephrine.
Subsequent additional research revealed that There is no difference in efficacy The difference between phenylephrine and placebo is likely due to orally ingested phenylephrine being inactivated in the intestine.
safety concerns
The 2023 advisory committee concluded that there were no documented safety issues with oral phenylephrine alone. However, researchers and advisory committee members have expressed concern that ineffective phenylephrine-containing products may remain on pharmacy shelves.
Even if oral phenylephrine is safe, taking an ineffective drug could result in consumers spending money on a product that is only as effective as a placebo. Placebo effect It is a well-known phenomenon in which people taking inert products may experience effects. The placebo tablets used in the phenylephrine study had the same or similar shape and color as the phenylephrine tablets, but did not contain the active ingredient.
The committee also noted that if phenylephrine remained on the market, the opportunity for pharmacists to recommend something more effective for nasal congestion would be lost.
Despite the advisory committee’s conclusions, no formal action has been taken by the FDA as of late October 2023. If FDA proposes changes to the availability of phenylephrine, consumers will be asked to consider their comments before making a final ruling.
The story behind pseudoephedrine
Fortunately, no prescription Oral nasal decongestant pseudoephedrine It is known to be effective and has been available commercially for many years. This medication is available as a single-ingredient product or in combination with other ingredients in products marketed to treat sinus congestion.
Pseudoephedrine is a nasal decongestant taken orally to relieve nasal congestion. It works by constricting blood vessels that are dilated due to colds, flu, and seasonal allergies.
However, purchasing products containing pseudoephedrine is not as easy as you might think. When pseudoephedrine is used, Manufacture the street drug methamphetaminethe FDA requires: sold behind the counter Daily and monthly quantities are limited. Photo ID is also required at time of sale.
If the FDA acts on the advisory committee’s conclusion that oral phenylephrine is not an effective nasal obstruction drug, pseudoephedrine could be the only remaining oral drug available to treat nasal congestion without a prescription. There is.here are some What you need to know about pseudoephedrine:
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Pseudoephedrine should not be used in doses greater than those recommended on the label. If you experience dizziness, nervousness, or insomnia, stop using products containing pseudoephedrine and consult your health care professional.
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Consumers with heart disease, high blood pressure, thyroid disease, diabetes, or enlarged prostate should not use pseudoephedrine without consulting their health care provider, such as a pharmacist or doctor.
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Products containing pseudoephedrine should not be used while taking or within 2 weeks after stopping taking prescription monoamine oxidase inhibitors, which are most commonly used to treat depression and Parkinson’s disease.
Other treatments
In addition to oral pseudoephedrine, medicated nasal sprays containing phenylephrine or oxymetazoline as active ingredients can also relieve nasal congestion. These products are sold under brand names such as Afrin.
but, Medications aren’t the only way to relieve congestion. Non-drug approaches include hot steam showers. Safe use of neti pot, a vaporizer or humidifier, a saline nasal spray, and a warm, damp washcloth on your face. All of these non-drug approaches can help relieve nasal passages and temporarily relieve nasal congestion. If her symptoms of congestion persist for more than two weeks or if she develops signs of infection, see a doctor.
Because products containing oral phenylephrine will remain on the market for the foreseeable future, it is important for consumers to read the labels on over-the-counter products to identify the active ingredients and their risks.
Before purchasing any over-the-counter product, talk to your pharmacist about your symptoms, medical condition, and other medicines you are taking. Your pharmacist can help you determine whether your condition can be managed with self-care or whether you need to see a doctor.
