FDA advisers will consider whether an ingredient in commonly used decongestants should be reclassified after the agency found it is ineffective. Oral formulations of phenylephrine, which is in drugs like Sudafed PE and some versions of NyQuil, doesn’t work at standard or even higher doses, the FDA said in briefing documents posted ahead of the two-day advisory meeting that starts Monday.
There have been long-running questions about the effectiveness of phenylephrine, and the FDA review raises potentially big implications for the over-the-counter drug market. Research firm IRI found that OTC pills that treat cough, sinus and flu symptoms — a category that includes phenylephrine — generated about $5 billion in sales in 2021, according to the Wall Street Journal.
Driving the news: If the committee of foreign advisors to the FDA agrees the ingredient is ineffective, that could lead to the agency revoking the drug’s designation as “Generally Recognized as Safe and Effective.” That would mean higher regulatory barriers for including phenylephrine in OTC products.
The FDA usually follows the advice of independent advisory committees, but it is not required to.
The FDA said it’s been monitoring the ingredient since the agency last reviewed it in 2007.
Since then, the FDA said, there have been three large trials of oral phenylephrine that it described as “by far the largest and most carefully conducted trials” of the ingredient ever conducted.
The trials “confirm that orally administered PE is not effective at any dose that can be developed and still provide a reasonable margin of safety,” the FDA wrote.
Effective Decongestants: Alternatives to Phenylephrine and Sudafed
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