FDA Proposes Removal of Oral Phenylephrine from OTC Products Due to Ineffectiveness

The FDA has proposed removing oral phenylephrine from over-the-counter (OTC) products used for nasal congestion. This decision follows a review of clinical data and the unanimous recommendation from the Nonprescription Drug Advisory Committee, which found that oral phenylephrine is not effective as a decongestant.

FDA Director Patrizia Cavazzoni stated, “It is the FDA’s role to ensure that drugs are safe and effective.” The proposed change will not affect nasal spray formulations of phenylephrine, which continue to be effective. Currently, products containing oral phenylephrine can still be sold. The FDA is collecting public comments before finalizing this decision.

Prayer Points

• Pray for Commissioner Robert Califf to make wise decisions at the FDA.
• Pray for FDA officials and advisors to be guided in their actions and approvals.

Source: Food and Drug Administration