The US Food and Drug Administration (FDA) has proposed removing oral phenylephrine (oral PE) as an active ingredient in over-the-counter flu medicines. The body assures that the compound is not very effective in relieving nasal congestion.
The health regulator reached this conclusion after reviewing the “available data” on the substance’s capacity. It indicates that products that add oral phenylephrine can continue to be marketed without restrictions. “The presence of phenylephrine in these medicines does not affect the way the other active ingredients work. to treat the symptoms for which they are designed,” he adds.
The agency analyzed pre-existing data on the safety and effectiveness of oral PE. It included records that were used to define the agent’s effectiveness as a nasal decongestant three decades ago. The most recent studies in this regard were also considered. The investigation was carried out by a committee of experts that unanimously determined that there is insufficient scientific evidence to support the use of phenylephrine in over-the-counter medicines.
“The FDA’s role is to ensure that merchandise is safe and effective. Based on our analysis and consistent with the advice of the advisory committee we are taking this next step in the process to propose the elimination of oral phenylephrine because it is not effective as a nasal decongestant,” explains Patrizia Cavazzoni, director of the agency’s Center for Drug Evaluation and Research (CDER).
The FDA suggestion is preliminary. A final ruling is required to determine which drugs that use oral phenylephrine can be marketed. The agency reiterates that its proposal “is based on considerations of effectiveness, not safety.”
Theresa Michele, director of CDER’s Office of Nonprescription Drugs, notes that “consumers should know that there are a wide range of other safe and effective treatments to temporarily relieve congestion symptoms due to allergies or the common cold. “Patients can also talk to their doctor or pharmacist about ways to treat these discomforts.”
What is phenylephrine?
The General Council of Pharmaceutical Colleges of Spain explains that phenylephrine is a substance that reduces the diameter of blood vessels (vasoconstrictor). Until now, it was believed that this effect on the ducts that supply the mucous glands of the nasal passages and paranasal sinuses would reduce the production of secretions. That is why the compound has been authorized for use in oral drugs to treat symptoms related to colds, flu or allergies.
The FDA proposal limited only to oral remedies that use phenylephrine. Michele clarified that “nasal spray versions of the medication to relieve congestion are not included in this review.” Atomizers containing the active ingredient work differently, because they are applied directly to the respiratory tract, which guarantees faster absorption.
The Consumer Healthcare Products Association accuses the FDA’s decision of being unfounded. It notes that “there are no reasons to change the overall safety and efficacy status of oral phenylephrine. Consumers need self-care options. Freedom of choice is a fundamental principle in the United States healthcare system.”
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