FDA to remove oral phenylephrine from OTC decongestants

The FDA has recommended the removal of oral phenylephrine from the list of approved active ingredients in over-the-counter (OTC) nasal decongestant products. This decision is based on a thorough evaluation indicating that oral phenylephrine is ineffective in alleviating nasal congestion.

The proposal is backed by recent data and insights from the FDA's Nonprescription Drug Advisory Committee, which found that the recommended dosage of oral phenylephrine does not consistently provide the desired relief for nasal congestion. Currently, oral phenylephrine is a common component in various OTC medications, either as a single ingredient or in combination with others, such as acetaminophen.

Importantly, the FDA highlighted that the ineffectiveness concerns pertain exclusively to the oral form of phenylephrine. Nasal sprays that contain phenylephrine are not affected by this proposal and continue to be considered effective. The focus of the FDA's proposal is strictly on the efficacy of oral phenylephrine as a nasal decongestant, with no safety issues being raised.

The FDA's evaluation included both historical data, which had initially validated phenylephrine's effectiveness as a nasal decongestant, and more recent studies that have called its efficacy into question. This comprehensive review led to the realization that oral phenylephrine does not work as originally believed, prompting the FDA to reconsider its approval status for this particular use.