ClickCease Phenylephrine No Longer Considered Effective | Easy Drug Card

Phenylephrine No Longer Considered Effective

What is phenylephrine?

Phenylephrine is a decongestant medication that is available over-the-counter under the generic name phenylephrine and the brand names Sudafed PE, Suphedrine PE, Sudogest PE, and Nasal Decongestant PE. Many combination over-the-counter cough and cold products contain phenylephrine as well. Some examples of these common combination products containing phenylephrine include DayQuil, NyQuil, Theraflu, Mucinex Fast-Max, Tylenol Cold + Flu, Alka-Seltzer Plus, and Robitussin Severe Multi-Symptom to name a few. When selecting combination cough and cold products, it is important to read the full list of ingredients to be sure the active drugs are appropriate for your specific circumstance. It is good practice to also read the label warning and directions for use of over-the-counter products. Phenylephrine also is available as a nasal spray under the brand name Neo-Synephrine, but this article will focus on the oral version of phenylephrine only. Phenylephrine is not to be mistaken with pseudoephedrine, which is sold under the brand name Sudafed. Sudafed (without the “PE”) is sold from behind the pharmacy counter and requires a photo ID to purchase the product. Whereas phenylephrine (Sudafed PE) can be found throughout the regular open pharmacy shelves.

See our blog about How To Avoid Rebound Congestion

FDA Advisory Committee News

Phenylephrine has been readily available as an over-the-counter congestion reliever, as the food and drug administration (FDA) had found it to be generally safe and effective when used as recommended. However, the advisory committee to the FDA, which provides the FDA with independent advice and recommendations, recently met and discussed the newer data available for phenylephrine. They concluded that the current scientific data does not support the idea that phenylephrine is effective as a nasal decongestant when used at the recommended dosage. They had no concern for the safety of the product but concluded that it is likely not effective to treat congestion. This conclusion does not apply to nasal spray products containing phenylephrine, but just the oral phenylephrine products. With this information, the medication will remain available over-the-counter for the time being until the FDA makes a decision based on the new information. The FDA advisory committee simply provides recommendations to the FDA, but the FDA makes any final decisions regarding the drug products.

What should you do in the meantime?

Also, see our blog – Can you use Mucinex for Postnasal Drip?

Though more recent scientific data suggests phenylephrine is ineffective for nasal decongestion, the product will remain readily available to the public as an over-the-counter medication. This will be until the FDA makes their own determination about the drug product. Phenylephrine is still considered safe, and the advisory committee did not raise any concerns about the safety of the drug. Therefore, if you take phenylephrine, it may not work well for congestion but likely is not harmful with normal use. Alternative over-the-counter products for congestion include nasal sprays and pseudoephedrine. Nasal congestion and treatment are dependent on the cause of the congestion. Congestion can be caused by common infections like the cold or flu or can be caused by other factors like allergies and seasonal changes. If you’re unsure which decongestant to use for symptom relief, speak with your health care provider or pharmacist.

Disclaimer: This blog is written for informational and educational purposes only. It is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read or seen online.

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Dr. Andrea M. Jones

Dr. Andrea M. Jones is a clinical pharmacist specializing in transitions of care to facilitate a smooth transition for patients between the hospital and outpatient settings. Dr. Jones graduated from the University of Colorado School of Pharmacy and completed post-graduate year 1 residency at the Southern Arizona VA Healthcare System in Tucson, Arizona. Dr. Jones also worked in retail/community pharmacies for over 5 years during undergraduate studies at the University of Kentucky and pharmacy school at the University of Colorado.




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