Food and Drug Administration Proposes Withdrawal of Ineffective Cold Medicine

Thursday, 7 November 2024, 17:32

Food and Drug Administration announced a proposal to withdraw a commonly used ingredient in cold medicines due to its ineffectiveness. The focus is on oral phenylephrine, an ingredient used in many OTC medications, which health experts claim does not work as intended. As questions around its safety and efficacy grow, the FDA's action could significantly impact the medical landscape for cold and cough treatments.
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Food and Drug Administration Proposes Withdrawal of Ineffective Cold Medicine

FDA's Proposal to Withdraw Oral Phenylephrine

The Food and Drug Administration has announced plans to remove a common ingredient in cold medicines from the market. Proposed for withdrawal is oral phenylephrine, deemed ineffective as a nasal decongestant by FDA scientists. This decision follows a year-long review and advice from outside experts questioning its initial approval data.

Impact of the Decision

The FDA aims to enhance public health by addressing the ineffectiveness of oral phenylephrine. Several widely used OTC products—such as Advil, NyQuil, Sudafed, Robitussin, Tylenol, and Theraflu—rely on this ingredient, and the rejection could alter their formulations dramatically.

What's Next?

As the FDA proceeds with this proposal, consumers and manufacturers will need to prepare for changes in the cold medicine market. This move could pave the way for more effective alternatives.


This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.


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