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If you live in the US, changes could be coming to your local pharmacy soon—namely the cold and flu aisle. Phenylephrine is commonly used as a decongestant in many of America's most well-known medicines, including Dayquil and Sudafed PE. However, in November 2024, the FDA proposed revoking phenylephrine in pill and liquid forms due to its ineffectiveness.
In this gallery, you'll find out everything you need to know about phenylephrine including what doctors and researchers are saying about it, why it is deemed ineffective, and possible alternatives.
Curious to know more about phenylephrine? Click through now.
Phenylephrine, a common decongestant, is used in medications such as Sudafed PE and Dayquil. But does it work?
Phenylephrine is often combined with other medicines to treat the common cold, flu, fever, and even allergies.
Many doctors view phenylephrine as ineffective and say that Americans would be better off without it.
In the US, the Food and Drug Administration regulates medications and ensures their safety and efficacy.
On November 7, 2024, the FDA proposed revoking phenylephrine approval for use in both liquid solutions and pills.
The decision followed a unanimous vote by federal advisors who stated that oral phenylephrine is ineffective in congestion relief.
Experts have reviewed both modern and historic studies and found that phenylephrine performed no better than placebos.
There are even studies from the 1960s and 1970s supporting phenylephrine that were found to have contained flaws and questionable data.
Despite being deemed ineffective, oral phenylephrine generates an incredible US$1.8 billion in annual sales.
If phenylephrine is used in nasal spray form, it is still considered effective. Sprays are less popular than oral medications despite being more effective, at least in this scenario.
After a 2006 law that restricted pseudoephedrine sales, many products replaced pseudoephedrine with phenylephrine.
Pseudoephedrine was moved behind pharmacy counters to restrict access due to its potential use in producing methamphetamine.
Some drugmakers reformulated their products with phenylephrine and rebranded them as "PE" versions in order to keep them easily accessible.
Consumers are still able to find pseudoephedrine-containing versions of decongestants. Examples include Sudafed and Claritin D at pharmacy counters.
If you're planning to purchase pseudoephedrine in the US, you'll need to bring a government photo ID to the pharmacy and present it to the pharmacist.
Over-the-counter options include items like nasal sprays that can help with congestion relief.
If you're hoping to get some congestion relief without medication, you can try saline drops or rinses which can help quickly clear mucus from the nose.
Doctors recommend nasal steroids such as Flonase for long-term treatment of congestion, itching, and sneezing.
Nasal steroids must be used daily for the best effectiveness. They also aren't ideal for immediate relief.
Astepro and other anti-histamine sprays are fast-acting for short-term relief.
Phenylephrine breaks down in the stomach, preventing it from entering the bloodstream and reaching the nasal passages.
Studies found that doses that are even 400% higher than a normal dose don’t effectively relieve nasal congestion.
According to the FDA, increasing phenylephrine doses beyond current levels may pose serious safety risks.
Oral phenylephrine will still be available for some time as there is a structured FDA regulatory process that must be followed.
Before phenylephrine is removed from shelves, the FDA must gather public comments, review feedback, and write a final order.
The timeline for removal is quite obscure as even after a final decision, companies will more than likely have a year or more to reformulate or remove products.
What's more, drugmakers can request additional FDA hearings, which can potentially delay the process further.
The Consumer Healthcare Products Association argues that consumers should always retain the choice to buy phenylephrine products.
Critics of the Consumer Healthcare Products Association's point of view say that offering a choice between effective and ineffective medicines is misleading.
Consumers should always educate themselves and seek a doctor's or medical professional's opinion when in doubt.
Sources: (AP) (CNBC)
The FDA has declared a common decongestant ineffective
What safe alternatives exist?
HEALTH Medicine
If you live in the US, changes could be coming to your local pharmacy soon—namely the cold and flu aisle. Phenylephrine is commonly used as a decongestant in many of America's most well-known medicines, including Dayquil and Sudafed PE. However, in November 2024, the FDA proposed revoking phenylephrine in pill and liquid forms due to its ineffectiveness.
In this gallery, you'll find out everything you need to know about phenylephrine including what doctors and researchers are saying about it, why it is deemed ineffective, and possible alternatives.
Curious to know more about phenylephrine? Click through now.