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0 / 31 Fotos
What is phenylephrine?
- Phenylephrine, a common decongestant, is used in medications such as Sudafed PE and Dayquil. But does it work?
© Getty Images
1 / 31 Fotos
Why is phenylephrine popular?
- Phenylephrine is often combined with other medicines to treat the common cold, flu, fever, and even allergies.
© Getty Images
2 / 31 Fotos
Doctors’ views on phenylephrine
- Many doctors view phenylephrine as ineffective and say that Americans would be better off without it.
© Shutterstock
3 / 31 Fotos
What is the FDA?
- In the US, the Food and Drug Administration regulates medications and ensures their safety and efficacy.
© Shutterstock
4 / 31 Fotos
FDA action on phenylephrine
- On November 7, 2024, the FDA proposed revoking phenylephrine approval for use in both liquid solutions and pills.
© Shutterstock
5 / 31 Fotos
Why the FDA acted
- The decision followed a unanimous vote by federal advisors who stated that oral phenylephrine is ineffective in congestion relief.
© Shutterstock
6 / 31 Fotos
Expert review of studies
- Experts have reviewed both modern and historic studies and found that phenylephrine performed no better than placebos.
© Shutterstock
7 / 31 Fotos
Flaws in early research
- There are even studies from the 1960s and 1970s supporting phenylephrine that were found to have contained flaws and questionable data.
© Shutterstock
8 / 31 Fotos
Oral phenylephrine sales
- Despite being deemed ineffective, oral phenylephrine generates an incredible US$1.8 billion in annual sales.
© Shutterstock
9 / 31 Fotos
Effectiveness in nasal sprays
- 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.
© Shutterstock
10 / 31 Fotos
Phenylephrine wasn't always standard
- After a 2006 law that restricted pseudoephedrine sales, many products replaced pseudoephedrine with phenylephrine.
© Shutterstock
11 / 31 Fotos
Why was pseudoephedrine restricted?
- Pseudoephedrine was moved behind pharmacy counters to restrict access due to its potential use in producing methamphetamine.
© Shutterstock
12 / 31 Fotos
“PE” products on shelves
- Some drugmakers reformulated their products with phenylephrine and rebranded them as "PE" versions in order to keep them easily accessible.
© Getty Images
13 / 31 Fotos
Consumer alternatives to phenylephrine
- Consumers are still able to find pseudoephedrine-containing versions of decongestants. Examples include Sudafed and Claritin D at pharmacy counters.
© Shutterstock
14 / 31 Fotos
How to buy pseudoephedrine products
- 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.
© Shutterstock
15 / 31 Fotos
Nasal spray alternatives
- Over-the-counter options include items like nasal sprays that can help with congestion relief.
© Shutterstock
16 / 31 Fotos
Saline drops and rinses
- 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.
© Shutterstock
17 / 31 Fotos
Nasal steroids for long-term relief
- Doctors recommend nasal steroids such as Flonase for long-term treatment of congestion, itching, and sneezing.
© Getty Images
18 / 31 Fotos
Limitations of nasal steroids
- Nasal steroids must be used daily for the best effectiveness. They also aren't ideal for immediate relief.
© Shutterstock
19 / 31 Fotos
Fast-acting antihistamine sprays
- Astepro and other anti-histamine sprays are fast-acting for short-term relief.
© Getty Images
20 / 31 Fotos
Why phenylephrine fails orally
- Phenylephrine breaks down in the stomach, preventing it from entering the bloodstream and reaching the nasal passages.
© Shutterstock
21 / 31 Fotos
Higher doses of oral phenylephrine don’t work
- Studies found that doses that are even 400% higher than a normal dose don’t effectively relieve nasal congestion.
© Shutterstock
22 / 31 Fotos
Safety risks of higher doses
- According to the FDA, increasing phenylephrine doses beyond current levels may pose serious safety risks.
© Shutterstock
23 / 31 Fotos
Future of oral phenylephrine
- Oral phenylephrine will still be available for some time as there is a structured FDA regulatory process that must be followed.
© Getty Images
24 / 31 Fotos
FDA's multistep process
- Before phenylephrine is removed from shelves, the FDA must gather public comments, review feedback, and write a final order.
© Shutterstock
25 / 31 Fotos
Timeline for removal
- 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.
© Shutterstock
26 / 31 Fotos
Drugmakers may delay action
- What's more, drugmakers can request additional FDA hearings, which can potentially delay the process further.
© Shutterstock
27 / 31 Fotos
Industry pushback
- The Consumer Healthcare Products Association argues that consumers should always retain the choice to buy phenylephrine products.
© Shutterstock
28 / 31 Fotos
Critics' response to industry
- Critics of the Consumer Healthcare Products Association's point of view say that offering a choice between effective and ineffective medicines is misleading.
© Shutterstock
29 / 31 Fotos
What this means for consumers
- Consumers should always educate themselves and seek a doctor's or medical professional's opinion when in doubt. Sources: (AP) (CNBC)
© Shutterstock
30 / 31 Fotos
© Shutterstock
0 / 31 Fotos
What is phenylephrine?
- Phenylephrine, a common decongestant, is used in medications such as Sudafed PE and Dayquil. But does it work?
© Getty Images
1 / 31 Fotos
Why is phenylephrine popular?
- Phenylephrine is often combined with other medicines to treat the common cold, flu, fever, and even allergies.
© Getty Images
2 / 31 Fotos
Doctors’ views on phenylephrine
- Many doctors view phenylephrine as ineffective and say that Americans would be better off without it.
© Shutterstock
3 / 31 Fotos
What is the FDA?
- In the US, the Food and Drug Administration regulates medications and ensures their safety and efficacy.
© Shutterstock
4 / 31 Fotos
FDA action on phenylephrine
- On November 7, 2024, the FDA proposed revoking phenylephrine approval for use in both liquid solutions and pills.
© Shutterstock
5 / 31 Fotos
Why the FDA acted
- The decision followed a unanimous vote by federal advisors who stated that oral phenylephrine is ineffective in congestion relief.
© Shutterstock
6 / 31 Fotos
Expert review of studies
- Experts have reviewed both modern and historic studies and found that phenylephrine performed no better than placebos.
© Shutterstock
7 / 31 Fotos
Flaws in early research
- There are even studies from the 1960s and 1970s supporting phenylephrine that were found to have contained flaws and questionable data.
© Shutterstock
8 / 31 Fotos
Oral phenylephrine sales
- Despite being deemed ineffective, oral phenylephrine generates an incredible US$1.8 billion in annual sales.
© Shutterstock
9 / 31 Fotos
Effectiveness in nasal sprays
- 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.
© Shutterstock
10 / 31 Fotos
Phenylephrine wasn't always standard
- After a 2006 law that restricted pseudoephedrine sales, many products replaced pseudoephedrine with phenylephrine.
© Shutterstock
11 / 31 Fotos
Why was pseudoephedrine restricted?
- Pseudoephedrine was moved behind pharmacy counters to restrict access due to its potential use in producing methamphetamine.
© Shutterstock
12 / 31 Fotos
“PE” products on shelves
- Some drugmakers reformulated their products with phenylephrine and rebranded them as "PE" versions in order to keep them easily accessible.
© Getty Images
13 / 31 Fotos
Consumer alternatives to phenylephrine
- Consumers are still able to find pseudoephedrine-containing versions of decongestants. Examples include Sudafed and Claritin D at pharmacy counters.
© Shutterstock
14 / 31 Fotos
How to buy pseudoephedrine products
- 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.
© Shutterstock
15 / 31 Fotos
Nasal spray alternatives
- Over-the-counter options include items like nasal sprays that can help with congestion relief.
© Shutterstock
16 / 31 Fotos
Saline drops and rinses
- 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.
© Shutterstock
17 / 31 Fotos
Nasal steroids for long-term relief
- Doctors recommend nasal steroids such as Flonase for long-term treatment of congestion, itching, and sneezing.
© Getty Images
18 / 31 Fotos
Limitations of nasal steroids
- Nasal steroids must be used daily for the best effectiveness. They also aren't ideal for immediate relief.
© Shutterstock
19 / 31 Fotos
Fast-acting antihistamine sprays
- Astepro and other anti-histamine sprays are fast-acting for short-term relief.
© Getty Images
20 / 31 Fotos
Why phenylephrine fails orally
- Phenylephrine breaks down in the stomach, preventing it from entering the bloodstream and reaching the nasal passages.
© Shutterstock
21 / 31 Fotos
Higher doses of oral phenylephrine don’t work
- Studies found that doses that are even 400% higher than a normal dose don’t effectively relieve nasal congestion.
© Shutterstock
22 / 31 Fotos
Safety risks of higher doses
- According to the FDA, increasing phenylephrine doses beyond current levels may pose serious safety risks.
© Shutterstock
23 / 31 Fotos
Future of oral phenylephrine
- Oral phenylephrine will still be available for some time as there is a structured FDA regulatory process that must be followed.
© Getty Images
24 / 31 Fotos
FDA's multistep process
- Before phenylephrine is removed from shelves, the FDA must gather public comments, review feedback, and write a final order.
© Shutterstock
25 / 31 Fotos
Timeline for removal
- 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.
© Shutterstock
26 / 31 Fotos
Drugmakers may delay action
- What's more, drugmakers can request additional FDA hearings, which can potentially delay the process further.
© Shutterstock
27 / 31 Fotos
Industry pushback
- The Consumer Healthcare Products Association argues that consumers should always retain the choice to buy phenylephrine products.
© Shutterstock
28 / 31 Fotos
Critics' response to industry
- Critics of the Consumer Healthcare Products Association's point of view say that offering a choice between effective and ineffective medicines is misleading.
© Shutterstock
29 / 31 Fotos
What this means for consumers
- Consumers should always educate themselves and seek a doctor's or medical professional's opinion when in doubt. Sources: (AP) (CNBC)
© Shutterstock
30 / 31 Fotos
The FDA has declared a common decongestant ineffective
What safe alternatives exist?
© Shutterstock
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.
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