A Popular OTC Decongestant Might Soon Be Pulled From Shelves for Being Useless
A common ingredient in over-the-counter cold and cough medicines might not be long for this world. The Food and Drug Administration is about to decide whether oral phenylephrine should remain in OTC nasal decongestant drugs. Outside experts will deliberate the topic and offer their recommendations this week, but FDA scientists have already argued that oral phenylephrine is practically worthless.
This week, the FDA is hosting an advisory committee meeting on nonprescription drugs, with one of the topics being whether oral phenylephrine should be pulled from the market as a nasal decongestant. The ingredient is found in many cold and allergy medicine brands, such as Sudafed PE and certain formulations of Nyquil. The specific change being debated is whether phenylephrine should lose its current designation of being “Generally Recognized as Safe and Effective,” or GRASE. In advance of this meeting, the agency’s own researchers detailed their conclusions in a report released last Thursday.
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The FDA’s review is not the final word on the subject. It’s possible that the advisory committee will recommend once again that oral phenylephrine remains on shelves. But even if the panel does recommend that, the FDA can still choose to ignore their advice and pull the drug anyway.
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