What's happened
The FDA has proposed removing oral phenylephrine from over-the-counter medications, citing its ineffectiveness as a nasal decongestant. This follows a unanimous recommendation from an expert panel last year. The agency is seeking public comments and will allow manufacturers time to reformulate products containing the ingredient.
Why it matters
What the papers say
According to the New York Times, the FDA's proposal to remove oral phenylephrine stems from a recommendation by an expert panel that unanimously agreed on its ineffectiveness. Dr. Patrizia Cavazzoni, director of the FDA's drug division, emphasized the agency's role in ensuring drug safety and efficacy. Meanwhile, the Consumer Healthcare Products Association expressed disappointment, stating that many consumers have relied on oral phenylephrine for relief. The Independent also noted that the FDA's action is not based on safety concerns but rather on the lack of effectiveness, which has been a long-standing issue raised by experts like Dr. Leslie Hendeles, who has campaigned for its removal since the 1990s.
How we got here
Oral phenylephrine has been used in cold and allergy medications for over 75 years. Recent studies have shown it to be ineffective when taken orally, prompting the FDA to reconsider its status as an over-the-counter drug.
Common question
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Why is the FDA banning oral phenylephrine?
The FDA's recent proposal to ban oral phenylephrine has raised many questions among consumers and healthcare professionals alike. This decision stems from concerns about the effectiveness of this common nasal decongestant. Below, we explore the reasons behind this ban, alternatives available, and what it means for over-the-counter medication options.
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