A common ingredient in over-the-counter nasal decongestants is not effective, the Food and Drug Administration said, a change to the agency’s position that could have major implications for some versions of Nyquil, Sudafed and Mucinex.
(Bloomberg) — A common ingredient in over-the-counter nasal decongestants is not effective, the Food and Drug Administration said, a change to the agency’s position that could have major implications for some versions of Nyquil, Sudafed and Mucinex.
The FDA said phenylephrine, an active ingredient in many over-the-counter cold and cough medicines, is not effective at standard or even higher doses, according to a report Thursday. The agency did not identify safety issues with phenylephrine. The FDA’s assessment comes ahead of a hearing next week in which an independent group of advisers will debate the consequences of pulling the ingredient from the market.
“Because this would represent a major change in the agency’s position, we believe that presenting this information in an open public forum, along with a full discussion and vote” from a committee of experts, the FDA said “will be extremely helpful.” The two-day hearing starts Monday, Sept. 11.
If the committee agrees it’s ineffective and the FDA ultimately pulls the ingredient from the market, manufacturers like Kenvue Inc., Reckitt Benckiser Group Plc and Procter & Gamble will have to reformulate or stop selling some medicines. Representatives for the three companies did not immediately respond to a request for comment.
Phenylephrine was previously reviewed by the FDA in 2007, when it held an advisory committee meeting after researchers from the University of Florida challenged whether it worked. A panel of outside experts at the time voted the ingredient was likely effective at existing doses but that more research was needed.
Since then, the FDA has continued to evaluate data on the issue. In one 2015 study of over 500 adults with seasonal allergies, seven days of treatment with phenylephrine at doses even higher than the norm was no better than a placebo at relieving nasal congestion.
The Consumer Healthcare Products Association, a US trade group for over-the-counter drugmakers, argues the ingredient is safe and effective, citing a body of research since the 1960s. In a report for next week’s meeting, the industry body said newer research into phenylephrine doesn’t “negate the conclusions of previous studies” and argued some of them were conducted on the wrong groups of people to evaluate efficacy.
Phenylephrine has increasingly been used as a substitute for pseudoephedrine in many non-prescription cold remedies in recent years. Commonly found in forms of Sudafed, pseudoephedrine can be used to make illegal forms of methamphetamine so since 2006, the US government has been requiring any medicines containing it be kept behind the counter.
More stories like this are available on bloomberg.com
©2023 Bloomberg L.P.