U.S. FDA advisory committee issues opinion that phenylephrine-containing pills are “ineffective”/Tim Boyle/Getty Images/File
2023.09.13 Wed posted at 18:30 JST
(CNN) On the 12th, an independent advisory committee of the U.S. Food and Drug Administration (FDA) concluded that phenylephrine, a common ingredient in over-the-counter anti-allergy and cold medicines, is not effective in pill form. The consensus was that
Phenylephrine is considered safe to use, and this point was not controversial. But many doctors have voiced doubts about phenylephrine’s effectiveness for years.
The FDA’s Non-Prescription Drug Advisory Committee will hold a two-day meeting starting on the 11th. A vote was taken on the 12th on the question, “Is the efficacy of phenylephrine orally administered at standard doses as a nasal decongestant supported by current scientific data?” and all 16 committee members unanimously voted. The conclusion was that it was “not substantiated.” The consensus was that there was no need for further research on this issue.
One of the committee members, Diane Ginsburg of the University of Texas at Austin School of Pharmaceutical Sciences, declared “ineffective products should not be distributed.”
The FDA said it would consider the committee’s recommendations, but did not specify a time frame. If the FDA decides to reclassify phenylephrine, which it considers generally safe and effective (GRASE), interested parties will have an opportunity to comment on the proposal and submit additional data. In the meantime, phenylephrine-containing products will still be allowed to be advertised, but if the FDA agrees with the advisory committee, manufacturers could be forced to stop selling phenylephrine-containing products or change their ingredients.
Although the committee did not address nasal spray products containing phenylephrine, some studies have shown that nasal sprays have at least a temporary effect.
#Overthecounter #drug #ingredient #phenylephrine #ineffective #tablet #form #FDA #advisory #committee
2023-09-13 09:30:00
