Last Updated on November 8, 2024 by The Health Master
Phenylephrine
In a significant move, the U.S. Food and Drug Administration (USFDA) has proposed the removal of oral phenylephrine as an active ingredient in over-the-counter (OTC) drugs for nasal congestion.
This widely used ingredient, found in popular cold and cough syrups like Benadryl, Advil, and Tylenol, has been deemed ineffective by the health regulator.
Phenylephrine: A Closer Look
Phenylephrine is commonly used in a range of OTC medications, including nasal sprays.
However, the USFDA’s proposed action specifically targets orally administered phenylephrine.
The agency’s decision is based on the findings of an expert panel, which unanimously concluded that oral phenylephrine is ineffective as a nasal decongestant.
The Controversy and Legal Battles
The ineffectiveness of oral phenylephrine has sparked controversy and legal battles.
Several companies, including Procter & Gamble and GSK, have faced lawsuits alleging that they misled consumers about the efficacy of their products containing phenylephrine.
USFDA Seeks Public Input
The USFDA is now seeking public comments on its proposed order.
While companies can continue to market drugs containing oral phenylephrine for the time being, they will eventually need to either reformulate their products or remove them from the market.
Industry Reaction
The Consumer Healthcare Products Association expressed disappointment with the USFDA’s proposal, stating that it contradicts the agency’s long-standing position on oral phenylephrine.
The association intends to review the proposed order and submit comments accordingly.
Related news: Phenylephrine used as a cold medicine is ineffective: USFDA Panel
Key Takeaways
- The USFDA has proposed removing oral phenylephrine from OTC drugs for nasal congestion.
- This decision is based on expert findings that the ingredient is ineffective.
- The move could impact a wide range of popular cold and cough medications.
- The USFDA is seeking public input on the proposed order.
- Companies will need to adapt their products or discontinue them.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.
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