An advisory panel to the Food and Drug Administration (FDA) unanimously agreed on Tuesday that phenylephrine, a common decongestant ingredient in many over-the-counter cold medicines, is ineffective.
The panel’s vote sets the stage for the FDA to potentially ban the ingredient, leading to the removal of hundreds of products containing it from store shelves.
If the FDA were to order their removal, popular products like Tylenol, Mucinex, and Benadryl cold and flu remedies could become unavailable as companies scramble to reformulate them.
While the FDA generally follows the recommendations of advisory panels, a final decision may take several months, and the findings could be disputed, causing further delays in product substitutions or removal from stores.
In the meantime, experts advise consumers not to panic or discard all the drugs in their medicine cabinet. Although phenylephrine does not effectively relieve nasal congestion when taken orally, it is not considered dangerous, and these products do contain other ingredients that can help alleviate cold symptoms.
The panel’s vote follows a review of existing studies, with the majority of advisers concluding that the research proves the ingredient is useless and no better than a placebo.
Some advisers noted that patients taking phenylephrine were merely delaying the use of more effective remedies.
Maria Coyle, the panel’s chairwoman, stated, “I think we clearly have better options in the over-the-counter space to help our patients, and the studies do not support that this is an effective drug.”
Dr. Leslie Hendeles, a pharmacist from the University of Florida, expressed that phenylephrine does not alleviate nasal congestion. She said, “If you have a stuffy nose and you take this medicine, you will still have a stuffy nose.”
Phenylephrine is found in at least 250 products, amounting to nearly $1.8 billion in sales last year. Popular products include Sudafed Sinus Congestion, Tylenol Cold & Flu Severe, NyQuil Severe Cold & Flu, Theraflu Severe Cold Relief, Mucinex Sinus Max, and others.
Phenylephrine and pseudoephedrine are the main oral decongestants in these products.
Under old agency standards, phenylephrine was considered safe and effective, and the FDA still maintains its safety. However, the panel’s vote suggests that the ingredient is ineffective in relieving nasal congestion. Nasal sprays containing phenylephrine, as well as its use in surgery or to dilate the eyes, are still considered effective.
Alternative medicines for congestion include products containing oral pseudoephedrine for colds and nasal steroids, antihistamines, and oral pseudoephedrine for hay fever or allergic rhinitis.
If the FDA decides to eliminate phenylephrine from products, it could disrupt the market for cold medicine manufacturers. This could potentially lead to increased use of pseudoephedrine, which is restricted due to its association with illicit meth labs.
Pseudoephedrine products require customers to follow certain procedures, including age restrictions, identification requirements, and purchase limits.
Pseudoephedrine also has side effects such as increased blood pressure and feelings of jitteriness and wakefulness.
The issue of phenylephrine’s effectiveness has been under discussion at the FDA for decades, with efforts to delay a decision likely to occur due to its potential impact on major corporations.
The FDA will consider panel expert opinions and public comments before making a final decision. The agency may also provide a grace period for companies to replace the ingredient in their products.
The Consumer Healthcare Products Association, which represents over-the-counter drug manufacturers, disagrees with the panel’s recommendation. They argue that phenylephrine is safe and effective, and removing it will burden consumers and strain the healthcare system.
Any changes or announcements regarding the ingredient’s status may take time, given the complexities involved and potential opposition from stakeholders.
