Overview
Phenylephrine, a common ingredient in over-the-counter cold medicines, could soon be banned from pharmacy shelves.
In November 2024 the Food and Drug Administration announced its proposal to remove phenylephrine from the approved list of over-the-counter drugs to treat nasal congestion, citing evidence that the oral version of the drug is ineffective.
This proposal comes about a year after an FDA advisory committee concluded that the drug does not work.
Companies can continue to market over-the-counter monograph drug products containing oral phenylephrine as a nasal decongestant. This is a proposed order. Only a final order will affect which products can be marketed. The proposed order is based on concerns about efficacy, not safety.
Introduction
Oral phenylephrine is widely used as an active ingredient in nasal decongestants found in various OTC (over-the-counter) monograph medicines. Some of these products contain only oral phenylephrine, while others combine it with additional ingredients such as acetaminophen or dextromethorphan. It is important to note that the presence of phenylephrine in these drugs does not interfere with the effectiveness of the other active ingredients in treating the symptoms for which they are intended.
The FDA has a responsibility to ensure that drugs are safe and effective.
The agency carried out a detailed review of all the available evidence on the safety and efficacy of oral phenylephrine, including the historical data that, 30 years ago, supported its approval as a nasal decongestant, as well as more recent clinical studies.
In 2023, the FDA convened the Nonprescription Drug Advisory Committee to evaluate the ‘Generally Recognized as Safe and Effective’ (GRASE) status of oral phenylephrine. After reviewing new data on its efficacy, the committee unanimously concluded that current scientific evidence does not support the efficacy of oral phenylephrine.
Products Contain Phenylephrine
Phenylephrine is widely used in cold and allergy medication to treat nasal congestion, as it’s thought to work by reducing swelling of the blood vessels in the nasal passages.
Phenylephrine isn’t always listed on the front of the box, as these products tend to contain multiple ingredients to treat various symptoms, so it’s best to check the active ingredients on the product label.
Brand names of oral phenylephrine products include:
Children’s Sudafed PE Nasal Decongestant
PediaCare Children’s Decongestant
Sudafed PE Congestion
Suphedrin PE
Why Has Phenyleprhine Been Used for So Long If It Doesn’t Work?
Oral phenylephrine has been used for decades as a nasal decongestant in over-the-counter (OTC) medicines due to a combination of historical, regulatory and scientific factors:
Based on Old Data: The approval of oral phenylephrine as a nasal decongestant was initially based on older studies, with different methodologies and standards than those required today. At the available data suggested that it could be effective, and these studies were considered sufficient for its approval.
Regulatory Change in the 2000: Phenylephrine gained even more popularity as an alternative after the restriction of pseudoephedrine, another effective nasal decongestant, due to its potential use in the illicit manufacture of methamphetamines. This led many manufacturers to replace pseudoephedrine with phenylephrine in their products.
Perceived Effectiveness: Many consumers reported some symptomatic relief, which can be attributed to placebo effects or individual variation in responses to the drugs.
Lack of Rigorous Review: For a long time, phenylephrine was not the subject of a modern regulatory review. Only recently did the FDA conduct a comprehensive review, using more rigorous scientific methodologies, which pointed to the lack of efficacy of oral phenylephrine at commonly used doses.
Trust in the Regulatory Process: Consumers and healthcare professionals tend to trust drugs that have been approved and are available on the market, assuming that they have been properly tested and are effective.
The FDA’s current review reflects advances in science and drug analysis, highlighting the need to re-evaluate products that were approved decades ago based on evidence that today would be considered insufficient.
If oral phenylephrine is banned by the FDA as an active ingredient in OTC nasal decongestants, there will be several implications for consumers, manufacturers and the OTC drug market.
What happens if phenyleprine is banned in cold medicines by the FDA?
- Impact on Consumers
- Reduced Options: Consumers will lose a widely available option for relieving nasal congestion, even though it is already known that oral phenylephrine is not effective.
- Search for Alternatives: They may be encouraged to look for other treatments, such as topical decongestants (nasal sprays) or medicines containing pseudoephedrine, which remains available but with sales restrictions.
- Changes in drug formulation
- Product reformulation: Manufacturers may need to reformulate their products, replacing phenylephrine with other effective active ingredients or removing the decongestant claim.
- Impact on Combination Medicines: Products that combine phenylephrine with other ingredients (such as acetaminophen or dextromethorphan) may also need to be adjusted.
- Market and Logistics
- Stock recalls and updates: Medicines containing phenylephrine as an active ingredient may be withdrawn from the shelves, which will require logistics for return and replacement.
- Costs for Manufacturers: Companies will incur additional costs related to reformulation, testing and repackaging of their products.
- Potential Increase in the Use of Pseudoephedrine
- Pseudoephedrine as an Alternative: Pseudoephedrine, which is more effective, may be more in demand, but it is subject to stricter regulations (it is sold behind the counter and with purchase limits).
- Focus on Topical Decongestants: Nasal sprays, such as those containing oxymetazoline, may gain popularity as they offer quick relief and are not subject to the same restrictions.
- Consumer Education
- Information Campaigns: It is likely that the FDA and health professionals will launch campaigns to educate the public about the reason for the ban and effective alternatives for treating nasal congestion.
- Global Effect
- Possible Influence on Other Countries: Regulators in other countries may follow the FDA’s example and review the use of phenylephrine in their markets, leading to global changes in the availability of this ingredient.
- Ultimately, the aim would be to ensure that the medicines available are based on sound scientific evidence, providing more effective treatments for consumers.
Conclusion
Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms.
Because a variety of different drug products may be sold under the same brand name, consumers should always read the Drug Facts label to determine which ingredients are in a medication, and to be aware of important warnings and directions for use. Phenylephrine is also an ingredient in nasal sprays to treat congestion. The FDA’s action is only related to orally administered phenylephrine and not the nasal spray form.
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References
Learn more about FDA. For the link, click here
Information about Nonprescription, Over-the-Counter (OTC), Oral Phenylephrine
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