The U.S. Food and Drug Administration (USFDA) on Friday announced that it is proposing to remove oral phenylephrine, a common ingredient in decongestants, after a detailed analysis on its effectiveness. Till now, phenylephrine was an active ingredient that can be used in over-the-counter (OTC) monograph drug products for the temporary relief of nasal congestion.
However, an agency review of the available data determined that oral phenylephrine is not effective for this use. For now, companies may continue to market OTC monograph drug products containing oral phenylephrine as a nasal decongestant. “This is a proposed order. Only a final order will affect what products can be marketed. The proposed order is based on effectiveness concerns, not on safety concerns,” FDA said in its statement.
Currently, oral phenylephrine is widely used as a nasal decongestant active ingredient in many OTC monograph drug products. It is important to note that some products only contain oral phenylephrine as a single, active ingredient. Others contain oral phenylephrine and another active ingredient (e.g., acetaminophen or dextromethorphan), and the presence of oral phenylephrine in these medicines does not affect how other active ingredients work to treat the symptoms for which they are intended, FDA explained.
“The agency conducted a comprehensive review of all available data on the safety and efficacy of oral phenylephrine, including the historical data that were used to support the determination made 30 years ago that oral phenylephrine was effective as a nasal decongestant, as well as newer clinical data on oral phenylephrine that have since become available,” the US regulatory body said in a statement.
As a variety of different drug products may be sold under the same brand name, consumers should always read the Drug Facts label to determine which ingredients are in a medication, and to be aware of important warnings and directions for use, FDA warned. Phenylephrine is also an ingredient in nasal sprays to treat congestion. The FDA’s action is only related to orally administered phenylephrine and not the nasal spray form.
“The FDA is seeking public comments on this proposed order. Instructions on how to submit comments are found in the proposed order available on OTC Monographs@FDA. If, after considering the comments, the FDA concludes oral phenylephrine is not effective as a nasal decongestant, the FDA will issue a final order removing oral phenylephrine from the OTC monograph, and drug products thereafter could no longer contain oral phenylephrine as a nasal decongestant,” it stated.
The FDA would provide manufacturers with appropriate time to either reformulate drugs containing oral phenylephrine or remove such drugs from the market, it added.