The Food and Drug Administration (FDA) is proposing to officially remove a popular ingredient in many cold and allergy medications – oral phenylephrine.
The active ingredient is used in over-the-counter decongestants; however, based on research from the FDA, the ingredient is ineffective at doing that, which is what prompted this proposed order.
“It is the FDA’s role to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”
What to know about oral phenylephrine
The FDA explained that this ingredient is used either as a single active ingredient in over-the-counter cold medications, or in combination with acetaminophen or dextromethorphan. Regardless of how it’s used, the FDA’s latest research has found that oral phenylephrine doesn’t do its job at relieving symptoms of congestion.
To come to this decision, the FDA looked at both the most current research available on oral phenylephrine, as well as the last three decades worth of research on utilizing the ingredient for decongestion.
Ultimately, they found that the drug is ineffective at helping relieve cold or allergy symptoms. However, consumers should also know there are no known major safety concerns with the ingredient.
Additionally, if the medication they take has other active ingredients, those will continue to do their job – even if oral phenylephrine doesn’t.
What happens next?
Because this issue is currently a proposed order, consumers will continue to see drugs with oral phenylephrine on store shelves. Once a final decision is made, then further action will be taken to remove these drugs from stores.
In the meantime, the FDA encourages consumers to check the labels on their cold and allergy medications and avoid anything that contains phenylephrine.
Some alternatives the agency recommends include:
Oral pseudoephedrine
Nasal sprays with nasal decongestants
Nasal sprays with corticosteroids
Nasal sprays with antihistamines
Cool mist humidifiers
Saline nose drops, rinses, or sprays
Nasal suctioning with a bulb syringe for kids
The FDA also recommends that consumers consult with their doctors or pharmacists if they have any questions about what they should or shouldn’t be taking.
“Consumers should know that a range of safe and effective drugs and other treatments are available to temporarily relieve congestion symptoms due to allergies or a common cold,” said Theresa Michele, M.D., director of the Office of Nonprescription Drug Products in CDER. “Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms.”