Review finds oral phenylephrine ineffective, leading to a proposal for market removal.
The U.S. Food and Drug Administration (FDA) recently proposed removing oral phenylephrine from over-the-counter (OTC) products intended for nasal congestion relief due to findings that it is not effective for this purpose. This proposed action follows a comprehensive review of clinical data and the unanimous recommendation of the Nonprescription Drug Advisory Committee. Although this is not a safety issue, the FDA’s proposal, if finalized, would lead to oral phenylephrine’s removal from OTC drugs.
“It is the FDA’s role to ensure that drugs are safe and effective,” said Director Patrizia Cavazzoni of the FDA’s Center for Drug Evaluation and Research (CDER). “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”
For now, products containing this ingredient can still be sold. The proposed FDA change will not impact nasal spray formulations of phenylephrine, which remain effective for congestion relief. The agency is accepting public comments before issuing a final order.
As the Lord Leads, Pray with Us…
- For Commissioner Robert Califf to be prudent as he oversees the FDA.
- For FDA officials and advisors to be led by the Lord in their actions and approvals.
Sources: Food and Drug Administration
