FDA Proposes Ending Use of Ineffective Decongestant Phenylephrine in OTC Medications

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The FDA has proposed to end the use of oral phenylephrine as an over-the-counter (OTC) nasal decongestant due to its ineffectiveness at recommended doses. The proposal is based on extensive scientific reviews and unanimous recommendations from FDA advisory committees, which concluded that oral phenylephrine is no more effective than a placebo in treating nasal congestion.

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Key Details of the Proposal:

Ineffectiveness:
- Studies have shown that oral phenylephrine does not effectively relieve nasal congestion because it is broken down by enzymes in the gut before it can reach the bloodstream, making it ineffective as a decongestant.
- The FDA advisory committee found that oral phenylephrine is not effective as a nasal decongestant and recommended its removal from the OTC monograph, which lists ingredients generally recognized as safe and effective (GRASE).

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Safety:
- While oral phenylephrine is not effective, it has not been shown to be unsafe when used at recommended doses.
Impact on Products:
- If the FDA finalizes the proposal, oral phenylephrine will be removed from OTC nasal decongestants. This could affect many well-known brands that contain this ingredient, such as Sudafed, Benadryl, and NyQuil.
- The removal of phenylephrine from OTC products could lead to a significant shift in the market for cold and allergy medications. Manufacturers would need to reformulate their products to ensure they remain effective without phenylephrine.
Alternatives:
- Consumers seeking alternatives for nasal congestion relief can consider other OTC options such as pseudoephedrine (available behind the pharmacy counter), oxymetazoline nasal sprays (e.g., Afrin), saline nasal sprays, and humidifiers.
- Topical decongestants like oxymetazoline are effective but should not be used for more than three days to avoid rebound congestion.
Future Steps:
- The FDA will consider public comments on the proposed order before making a final decision. If the proposal is finalized, the public will still have the opportunity to comment before the final order is issued.
- The FDA remains committed to ensuring that OTC medicines are safe and effective, and it will work closely with manufacturers to ensure the availability of effective alternatives.

Conclusion:

The FDA's proposal to remove oral phenylephrine from OTC nasal decongestants is driven by its ineffectiveness, despite being generally recognized as safe. This move aims to ensure that consumers have access to effective treatments for nasal congestion, while also prompting manufacturers to reformulate their products to meet new standards.

FDA Proposes Ending Use of Ineffective Decongestant Phenylephrine in OTC Medications

Preview

Key Details of the Proposal:

Ineffectiveness:
- Studies have shown that oral phenylephrine does not effectively relieve nasal congestion because it is broken down by enzymes in the gut before it can reach the bloodstream, making it ineffective as a decongestant.
- The FDA advisory committee found that oral phenylephrine is not effective as a nasal decongestant and recommended its removal from the OTC monograph, which lists ingredients generally recognized as safe and effective (GRASE).

Preview

Safety:
- While oral phenylephrine is not effective, it has not been shown to be unsafe when used at recommended doses.
Impact on Products:
- If the FDA finalizes the proposal, oral phenylephrine will be removed from OTC nasal decongestants. This could affect many well-known brands that contain this ingredient, such as Sudafed, Benadryl, and NyQuil.
- The removal of phenylephrine from OTC products could lead to a significant shift in the market for cold and allergy medications. Manufacturers would need to reformulate their products to ensure they remain effective without phenylephrine.
Alternatives:
- Consumers seeking alternatives for nasal congestion relief can consider other OTC options such as pseudoephedrine (available behind the pharmacy counter), oxymetazoline nasal sprays (e.g., Afrin), saline nasal sprays, and humidifiers.
- Topical decongestants like oxymetazoline are effective but should not be used for more than three days to avoid rebound congestion.
Future Steps:
- The FDA will consider public comments on the proposed order before making a final decision. If the proposal is finalized, the public will still have the opportunity to comment before the final order is issued.
- The FDA remains committed to ensuring that OTC medicines are safe and effective, and it will work closely with manufacturers to ensure the availability of effective alternatives.