Ineffectiveness of Oral Decongestant Ingredient Highlighted by FDA Panel

Oral phenylephrine-based (PE) decongestants, widely used for nasal congestion, have been deemed ineffective by a US FDA expert panel after analyzing clinical trials. The medicine fails to alleviate nasal stuffiness when ingested due to significant breakdown before entering the bloodstream. Consequently, the panel recommends reclassifying oral PE decongestants to prevent misleading labeling. This may compel manufacturers to reformulate popular products. While the FDA’s response is pending, a trade organization representing manufacturers expresses concern. In contrast, scientists and researchers welcome the findings. In 2022, PE decongestants generated $1.76 billion in sales in the US, while effective alternatives like pseudoephedrine (PSE) made $542 million. Consumer education is crucial for choosing appropriate alternatives.


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