FDA advisers will consider whether an ingredient in commonly used decongestants should be reclassified after the agency found it is ineffective.
Driving the news: 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.
Driving the news: If the committee of outside 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.”
Catch up quick: The FDA said it’s been monitoring the ingredient since the agency last reviewed it in 2007.
Of note: The FDA said it hasn’t identified any safety issues with the ingredient, but it said it’s concerned about possible unintended consequences of revoking its OTC status.