A panel of independent experts from the Food and Drug Administration (FDA) concluded that phenylephrine, a popular ingredient in many over-the-counter allergy and cold medications, is ineffective.
It is a main ingredient in products such as Benadryl Allergy Plus Congestion, Sudafed PE and Vicks Sinex. "The Agency undertook a careful and thorough review of all of the available data. The new data appear compelling that the monographed dosage of oral PE results in no meaningful systemic exposure or evidence of efficacy," detailed the report issued by the panel.
Backgrounder FDA by Williams Perdomo on Scribd
Higher doses are also ineffective
In addition, the expert review suggests that using higher doses that have been clinically tested up to 40 mg every four hours have also not shown efficacy. Although the use of the ingredient was considered safe, experts had already questioned the effectiveness of these drugs.
"These products generated nearly $1.8 billion in sales last year alone, according to FDA data presented to the Nonprescription Drug Advisory Committee on Monday during the committee's two-day meeting," CNN reviewed.
The FDA said it will take the expert panel's conclusion into consideration. However, it did not elaborate on its final decision regarding the sale of the drug. CNN explained that, if the agency decides to reclassify phenylephrine, interested parties would have the opportunity to comment on the proposed change and provide any additional data.
"During that process, companies would still be able to market products with phenylephrine. But if the FDA agrees with the committee, companies may be required to remove products with phenylephrine from store shelves or reformulate them," CNN detailed.
Phenylephrine was approved by the agency for over-the-counter use in the 1970s. In 2007, the FDA committee reviewed the data available at the time and concluded that phenylephrine may be ineffective, but also called for more research.
