(Bloomberg) — The U.S. Food and Drug Administration says a common ingredient in over-the-counter nasal decongestants is ineffective, and a change in the agency’s stance could have a significant impact on some versions of Nyquil, Sudafed and Mucinex.
The FDA announced that phenylephrine, the active ingredient in many over-the-counter cold and cough remedies, is ineffective at standard doses and even higher doses, according to a report released Thursday. The agency found no safety concerns with phenylephrine. The FDA’s assessment comes ahead of a hearing next week in which an independent advisory panel will discuss the consequences of removing the ingredient from the market.
“Because this would represent a significant change in the agency’s position, we believe it would be useful to present this information in a public forum, with full debate and vote by an expert committee,” the FDA said. The two-day hearing will begin on Monday, September 11.
If the committee agrees that the ingredient is ineffective and FDA ultimately removes the ingredient from the market, Manufacturers such as Kenvue Inc, Reckitt Benckiser Group Plc and Procter & Gamble Co will have to reformulate or stop selling certain drugs. Representatives for the three companies did not immediately respond to requests for comment.
The FDA reviewed phenylephrine in 2007, when University of Florida researchers questioned its effectiveness and the agency convened an advisory committee meeting. A group of outside experts then voted that the ingredient may be effective at existing doses, but that more research is needed.
The FDA has since continued to evaluate data on this issue.andA 2015 study of more than 500 adults with seasonal allergies received seven days of phenylephrine at an even higher than normal dose They were no better than placebo at relieving nasal congestion.
The Consumer Healthcare Association, a U.S. trade group for over-the-counter drug manufacturers, insists the ingredient is safe and effective, citing a series of studies conducted since the 1960s. In a report at next week’s meeting, the association said the new studies on phenylephrine did not “invalidate the conclusions of previous studies” and argued that some of the studies were conducted in the wrong populations to assess their effectiveness.
In recent years, phenylephrine has been increasingly used as an alternative to pseudoephedrine in many over-the-counter cold medications. The pseudoephedrine commonly found in Sudafed can be used to make illegal forms of methamphetamine, which is why since 2006 the U.S. government has required that all drugs containing pseudoephedrine not be sold over the counter.
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