Surprising Revelation: FDA Experts Confirm Common Nasal Decongestant Ineffective – Orange County Register

By CAILLEY LAPARA | Bloomberg

A panel of regulatory advisers in the US has unanimously recommended that phenylephrine, a key ingredient in certain over-the-counter cold medicines, including some versions of Procter & Gamble Co.’s Nyquil, has no proven effectiveness.

The committee, composed of 16 advisers to the Food and Drug Administration (FDA), concluded that there is insufficient scientific evidence to support the efficacy of oral phenylephrine at recommended doses. Furthermore, the majority of panelists agreed that conducting further studies to test higher doses of the drug would not be worthwhile.

While the advisory committee’s decision is not binding, the FDA’s own staff have also expressed doubts about the efficacy of phenylephrine. Should the agency follow the panel’s recommendation, it could initiate the process of removing the drug from the market. This would require manufacturers, including P&G, Kenvue Inc. (Sudafed), and Reckitt Benckiser Group (Mucinex), to reformulate their popular cough and cold products.

Also see: COVID-19, flu and RSV: A guide to this fall’s vaccine options

The companies mentioned did not respond to requests for comment.

According to the FDA, consumers spent approximately $1.8 billion on products containing phenylephrine in 2022. However, many cold remedies that contain the decongestant also contain other active ingredients such as antihistamines and cough suppressants.

As a substitute for pseudoephedrine, phenylephrine has increasingly been used in non-prescription cold remedies. Pseudoephedrine, commonly found in Sudafed, can be utilized to make illegal forms of methamphetamine. Since 2006, the US government has required medicines containing pseudoephedrine to be kept behind the counter.

Pharmacist’s Dilemma

Reference

Denial of responsibility! Vigour Times is an automatic aggregator of Global media. In each content, the hyperlink to the primary source is specified. All trademarks belong to their rightful owners, and all materials to their authors. For any complaint, please reach us at – [email protected]. We will take necessary action within 24 hours.
Denial of responsibility! Vigour Times is an automatic aggregator of Global media. In each content, the hyperlink to the primary source is specified. All trademarks belong to their rightful owners, and all materials to their authors. For any complaint, please reach us at – [email protected]. We will take necessary action within 24 hours.
DMCA compliant image

Leave a Comment