
The FDA proposed the removal of oral phenylephrine from over-the-counter (OTC) drugs for nasal congestion relief, following an extensive review of clinical data that determined the ingredient’s lack of effectiveness. The advisory committee supported the decision, concluding that phenylephrine does not meet the effectiveness criteria at recommended dosages. Although the proposal does not affect products currently on the market, it calls for public comments before finalizing the removal. The FDA clarified that the action is not based on safety concerns and does not impact nasal spray forms of phenylephrine. Should the final order proceed, manufacturers will be granted time to reformulate or withdraw affected products.
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