A recent advisory by the Food and Drug Administration’s (FDA) Nonprescription Drug Advisory Committee that recommends a re-evaluation of the effectiveness of oral phenylephrine in over-the-counter (OTC) cough and cold products has caused some confusion and uncertainty about products that contain phenylephrine, and what people can use to help manage congestion issues.
Sonali Kshatriya, pharmacist and manager in the Walgreens office of clinical integrity, explains what the phenylephrine advisory means for you and your family, and offers product recommendations so patients suffering from congestion can make it comfortably through cold and flu season.
A: The FDA oversees the regulation of OTC medications. Currently, there are two regulatory pathways in the U.S. for the FDA to approve a nonprescription drug. One is the drug application process and the other is the OTC Drug Review—often used for older drugs—that establishes the general category of the drug and includes active ingredients, use, doses, routes of administration, and is given their GRASE (Generally Recognized as Safe and Effective) designation for its intended use. This allows drug makers to include a drug in this designation without FDA pre-approval. However, the FDA can add, change, or remove the GRASE designation after following a specific administrative process.
This kind of opinion is exactly what regulatory agencies like the FDA are structured to do. They review and evaluate available data and evidence to make informed decisions to support public-health-related approvals and guidance. As there is more information, recommendations may change based on that information. This is a strength of the system, to adapt to this data.
Phenylephrine-containing nasal sprays were not included in the review and will not be impacted by any future FDA actions related to this specific recommendation.
Sonali Kshatriya, pharmacist and manager in the Walgreens office of clinical integrity, explains what the phenylephrine advisory means for you and your family, and offers product recommendations so patients suffering from congestion can make it comfortably through cold and flu season.
Q: How does the process work for FDA review of OTC medications?
A: The FDA oversees the regulation of OTC medications. Currently, there are two regulatory pathways in the U.S. for the FDA to approve a nonprescription drug. One is the drug application process and the other is the OTC Drug Review—often used for older drugs—that establishes the general category of the drug and includes active ingredients, use, doses, routes of administration, and is given their GRASE (Generally Recognized as Safe and Effective) designation for its intended use. This allows drug makers to include a drug in this designation without FDA pre-approval. However, the FDA can add, change, or remove the GRASE designation after following a specific administrative process.Q: How does the FDA advisory committee's recommendation impact how people should view phenylephrine?
A: The advisory committee reached the conclusion that the FDA should re-evaluate the original GRASE designation of oral phenylephrine after reviewing data around how effective the drug may be as a decongestant when taken in pill or liquid form. It is important to understand that this is not an official drug recall or questioning the safety of oral phenylephrine, but rather it is solely reviewing the data to determine effectiveness. The FDA will now need to decide what to do next, including if it will keep or remove the GRASE designation for OTC oral forms of phenylephrine.This kind of opinion is exactly what regulatory agencies like the FDA are structured to do. They review and evaluate available data and evidence to make informed decisions to support public-health-related approvals and guidance. As there is more information, recommendations may change based on that information. This is a strength of the system, to adapt to this data.
Q: Does the advisory from the FDA panel apply to all forms of phenylephrine?
A: The evidence reviewed and discussed by the FDA advisory committee and its subsequent recommendations were only related to OTC oral phenylephrine (tablets, liquids, etc.) The committee focused on whether oral phenylephrine, when used as labeled, provided clinically significant relief, and reported that the results of several studies of oral phenylephrine did not support the efficacy claims.Phenylephrine-containing nasal sprays were not included in the review and will not be impacted by any future FDA actions related to this specific recommendation.
Q: What is Walgreens position on phenylephrine?
A: Walgreens follows guidance from regulatory agencies such as the FDA and is always committed to providing customers safe and effective options for their care. Walgreens pharmacists are available to help answer questions about phenylephrine as well as offer alternative recommendations for symptom relief to help customers feel better.Q: As we move into cold and flu season, what products do you recommend to people who may now be looking for a different way to treat congestion?
A: There are a variety of medication options for congestion relief if you are looking for alternative products in place of oral phenylephrine. People can consider nasal spray forms of phenylephrine that are not part of the FDA committee’s advisory, like Wal-Four Nasal Spray, or products with pseudoephedrine as the active ingredient such as Sudafed®, which can be found behind the pharmacy counter (note: OTC Sudafed PE 10mg oral tablets contain phenylephrine). If the congestion is due to allergies, antihistamines with active ingredients such as loratadine or fexofenadine are options, along with fluticasone nasal spray. Non-drug options such as humidifiers, saline spray or rinse (neti pot) may also provide some relief. As always, you should read the label and take the product as directed and check with your doctor or pharmacist if you have other health conditions.Q: What should people do with products they currently have that include phenylephrine as an ingredient?
A: FDA approval status for products containing phenylephrine has not changed at this time, and there is no formal recommendation for retailers to stop selling or consumers to stop using phenylephrine. However, consumers who wish to use a different OTC medicine should be aware that there are many options available to provide relief from congestion symptoms, and should ask their pharmacist or doctor if they have questions.