Popular decongestant ‘no better than placebo’, says FDA panel
More than 240 million bottles and packages of OTC products containing phenylephrine were sold in 2022, show retail sales estimates.
Oral phenylephrine, a nasal decongestant in dozens of OTC cold and flu medications, is no better than placebo and could be struck off therapeutic goods lists, a US Food and Drug Administration panel has found.
The drug watchdog will now weigh up banning the ingredient, potentially forcing dozens of products off pharmacy shelves.
The non-binding recommendation of the US Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee is that oral phenylephrine is safe but “not effective as a nasal decongestant”.
The committee’s 89-page report, published this week, stressed that nasal sprays with phenylephrine were still considered effective.
