The U.S. Food and Drug Administration (FDA) has proposed removing oral phenylephrine from over the counter (OTC) medications used for nasal congestion relief. This proposal follows a review that found oral phenylephrine ineffective for this purpose. The FDA’s proposal is based on concerns about the drug’s effectiveness, not its safety.
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Oral phenylephrine is commonly found in many OTC drugs, either as a sole active ingredient or alongside others like acetaminophen or dextromethorphan. The FDA clarified that phenylephrine’s ineffectiveness does not impact the function of these other ingredients in treating symptoms.
Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, emphasized the agency’s commitment to ensuring drug efficacy and safety. The proposed removal stems from both historical and recent clinical evidence suggesting oral phenylephrine does not effectively alleviate nasal congestion.
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Last year, the FDA’s Nonprescription Drug Advisory Committee reviewed the scientific data and unanimously agreed that oral phenylephrine’s recommended dosage is not effective in OTC products. Theresa Michele, M.D., from the Office of Nonprescription Drug Products, reassured consumers that various effective treatments for congestion due to allergies or colds are still available. She advises consumers to check Drug Facts labels for ingredient details.
It’s important to note that this action applies only to orally administered phenylephrine, not the nasal spray form. The FDA invites public comments on this proposal. Should the FDA’s final decision confirm inefficacy, manufacturers will have to reformulate or remove products containing oral phenylephrine. Instructions for submitting feedback are available on the FDA’s OTC Monographs.
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