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What is phenylephrine? -

Phenylephrine, a common decongestant, is used in medications such as Sudafed PE and Dayquil. But does it work?

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Why is phenylephrine popular? -

Phenylephrine is often combined with other medicines to treat the common cold, flu, fever, and even allergies. 

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Doctors’ views on phenylephrine -

Many doctors view phenylephrine as ineffective and say that Americans would be better off without it.

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What is the FDA? -

In the US, the Food and Drug Administration regulates medications and ensures their safety and efficacy.

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FDA action on phenylephrine -

On November 7, 2024, the FDA proposed revoking phenylephrine approval for use in both liquid solutions and pills.

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Why the FDA acted -

The decision followed a unanimous vote by federal advisors who stated that oral phenylephrine is ineffective in congestion relief.

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Expert review of studies -

Experts have reviewed both modern and historic studies and found that phenylephrine performed no better than placebos.

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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.

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Oral phenylephrine sales -

Despite being deemed ineffective, oral phenylephrine generates an incredible US$1.8 billion in annual sales.

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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.

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Phenylephrine wasn't always standard -

After a 2006 law that restricted pseudoephedrine sales, many products replaced pseudoephedrine with phenylephrine. 

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Why was pseudoephedrine restricted? -

Pseudoephedrine was moved behind pharmacy counters to restrict access due to its potential use in producing methamphetamine.

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“PE” products on shelves -

Some drugmakers reformulated their products with phenylephrine and rebranded them as "PE" versions in order to keep them easily accessible.

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Consumer alternatives to phenylephrine -

Consumers are still able to find pseudoephedrine-containing versions of decongestants. Examples include Sudafed and Claritin D at pharmacy counters.

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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.

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Nasal spray alternatives -

Over-the-counter options include items like nasal sprays that can help with congestion relief.

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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.

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Nasal steroids for long-term relief -

Doctors recommend nasal steroids such as Flonase for long-term treatment of congestion, itching, and sneezing.

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Limitations of nasal steroids -

Nasal steroids must be used daily for the best effectiveness. They also aren't ideal for immediate relief.

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Fast-acting antihistamine sprays -

Astepro and other anti-histamine sprays are fast-acting for short-term relief.

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Why phenylephrine fails orally -

Phenylephrine breaks down in the stomach, preventing it from entering the bloodstream and reaching the nasal passages.

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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.

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Safety risks of higher doses -

According to the FDA, increasing phenylephrine doses beyond current levels may pose serious safety risks.

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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.

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FDA's multistep process -

Before phenylephrine is removed from shelves, the FDA must gather public comments, review feedback, and write a final order.

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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.

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Drugmakers may delay action -

What's more, drugmakers can request additional FDA hearings, which can potentially delay the process further.

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Industry pushback -

The Consumer Healthcare Products Association argues that consumers should always retain the choice to buy phenylephrine products.

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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.

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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)

See also: Medicine side effects and how to deal with them

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