September 23, 2023

By Cailley LaPara | Bloomberg

A panel of US regulatory advisers stated phenylephrine, a major part of over-the-counter chilly medicines together with some variations of Procter & Gamble Co.’s Nyquil, doesn’t really work.

The committee of 16 advisers to the Meals and Drug Administration voted unanimously on Tuesday that scientific proof doesn’t show that the nasal decongestant is efficient when taken orally at beneficial doses. Nearly all of panelists agreed that additional research to check greater doses of the drug wouldn’t be worthwhile.

The advisory committee’s choice isn’t binding, however the FDA’s personal employees have additionally questioned phenylephrine’s efficacy. If the company follows the panel’s advice, it might subsequent start a course of to take away the drug from the market, forcing producers, together with P&G, Kenvue Inc. (Sudafed) and Reckitt Benckiser Group (Mucinex), to reformulate many in style cough and chilly merchandise.

The businesses didn’t reply to requests for remark.

Shoppers spent about $1.8 billion on merchandise containing phenylephrine in 2022, in accordance with the FDA, though many chilly treatments with the decongestant additionally include different energetic elements like antihistamines and cough suppressants.

Phenylephrine has more and more been used as an alternative choice to pseudoephedrine in lots of non-prescription chilly treatments. Generally present in types of Sudafed, pseudoephedrine can be utilized to make unlawful types of methamphetamine. Since 2006, the US authorities has been requiring medicines containing it to be stored behind the counter.

Pharmacist’s Dilemma