CVS Health announced on October 19 that certain oral cough and cold products in which phenylephrine is the only active ingredient will be removed from store shelves. The pharmacy chain’s decision was in response to a September 12 announcement by Food and Drug Administration advisers that phenylephrine (the main ingredient in popular over-the-counter decongestants) was found in under familiar brand names such as Sudafed PE, Vicks DayQuil, Theraflu and others were not effective). . After a two-day meeting, a panel of 16 experts unanimously concluded that the popular drug actually worked no better than a placebo.
The advisory panel’s conclusions are not binding, and the FDA has not yet decided whether to take action and remove phenylephrine from the list of ingredients for OTC use. Rival pharmacy chain Walgreens said on Thursday that it complies with FDA regulations and is monitoring the situation, Reuters reported.
What is “phenylephrine”?
Phenylephrine is an over-the-counter medication that has been used for decades to relieve nasal congestion and congestion caused by allergies or colds, and is thought to work by reducing swelling of blood vessels in the nasal passages.
The FDA advisory panel concluded that the oral form of phenylephrine was not effective, but nasal sprays and drops containing phenylephrine have not been reviewed and are still considered effective.
Phenylephrine has been around for a long time, what has changed?
In 2007, researchers at the University of Florida questioned the effectiveness of phenylephrine decades after its “legacy” approval during an FDA review that began in 1972, but the FDA allowing it to remain on the market pending additional research. The same University of Florida researchers again called on the FDA to remove phenylephrine products from shelves after recent studies showed they were no better than placebo at treating nasal congestion caused by colds and flu. allergy.
A lot has changed since 2007, Dr. Zara Patel of Stanford Medicine, tells Yahoo Life. Science has improved, the way we research drugs has improved, and even the outcome measures we use to determine whether nasal congestion is getting better have improved.
She added that people should not be upset about this new update.
This is just how science works. That’s the beauty of science, we can collect lots of new, better data and allow that data to change our thinking about something.
Experts Yahoo Life spoke to said they weren’t surprised and that many clinicians have avoided recommending phenylephrine to patients.
We’ve known that for a long time, Dr. J. Routt Reigart, chair of the American Academy of Pediatrics’ committee on drugs, told Yahoo Life. Most pediatricians do not knowingly prescribe medications containing phenylephrine.
Why doesn’t it work?
Experts concluded that when taken orally, phenylephrine is metabolized quite quickly, so the amount absorbed into the bloodstream will be less than 1% of the initial intake and not enough to be effective.
But if you’ve used phenylephrine in the recommended dosage before, you don’t need to worry. FDA advisories did not warn of any new side effects or dangers when taken as directed.
Not everyone is at risk, it’s just not effective, Patel said. I would say it’s more of a waste of time [and] a waste of money.
Why does phenylephrine seem to work for me?
If oral phenylephrine is your solution for nasal congestion, you may be confused to learn that it’s really no better than a dummy pill. Experts say there may be some placebo effect as patients feel relief thanks to their belief in the pill’s power.
Patel says that if medications containing phenylephrine have helped you feel better in the past, it may have more to do with the other ingredients involved.
She says that most of the time phenylephrine is combined with other medications that help relieve other symptoms people have with colds or allergies. Any over-the-counter common cold and sinus medications or over-the-counter allergy medications, they will not only have phenylephrine in them. They have phenylephrine plus some mucus thinning medication, maybe some expectorant to help with coughing or coughing. There are a lot of different medications that are often combined in these general cold or antihistamine pills and that may actually be why they actually provide some benefit.
It is also possible that some people received some benefit from oral phenylephrine, but FDA advisors concluded that was not true for the majority of people.
When we talk about safety and effectiveness, we are looking at an average,” explains Patel. Some people are more sensitive to the drug, so it is possible that some people will experience certain effects at lower doses than others. When we say a drug is ineffective, we mean that the majority of people taking that drug do not find it effective. That doesn’t mean some people might not have it.
What happens next and what should I use instead?
If the FDA decides to follow the advisory panel’s recommendation, drug manufacturers could be required to remove oral phenylephrine from store shelves. But that process may take some time.
“Advisory committees provide independent advice and recommendations to the FDA, but the agency makes the final decision,” the FDA said in a statement on September 14. “The FDA will consider comments contribution of this advisory committee and evidence before taking any action.” on the status of oral phenylephrine.”
Meanwhile, experts say there are many options.
Dr. James Tracy, vice president of the American College of Allergy, Asthma and Immunology, tells Yahoo Life that there are many other products that actually work. Almost all nasal sprays, such as antihistamine nasal sprays, work and are also over-the-counter medications, but they don’t claim to be decongestants.
Pseudoephedrine is the most common decongestant alternative, but because it has the potential for abuse, you may need to ask a pharmacist to help you get it over the counter. Some states also have per-family limits on how much you can buy or may require you to show some form of identification.
In addition to safe and effective topical steroid sprays and topical antihistamine sprays, phenylephrine is still considered effective in nasal spray form although Tracy warns it can be addictive if used regularly.
He says of phenylephrine nasal sprays, you should only use them for two to three days maximum. There can certainly be side effects of what we call rebound congestion [if overused]But they definitely work.
For children with allergies, Reigart says saline nasal drops or first-generation antihistamines like Benadryl can be beneficial for nasal congestion. But sometimes, you can skip the medicine.
My advice for the common cold or runny nose, if non-allergenic, is to not use anything, says Reigart.
This article was originally published on September 13, 2023 and has been updated.
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