A 16-person FDA advisory panel agreed Sept. 12 that oral phenylephrine, an ingredient commonly found in over-the-counter cold and allergy medications, does not help with nasal congestion.
Phenylephrine, an ingredient approved for nasal congestion in 1976, has long been scrutinized because of research disproving its efficacy. The FDA meeting was originally scheduled for April 12 before the FDA postponed it to Sept. 11-12.
The ingredient is in multiple forms, including pills, nasal sprays and liquids, but the panel exclusively focused on the pill solutions. FDA data found that only a tiny amount of the oral solution reaches the nose, and its efficacy is similar to a placebo. If phenylephrine loses its over-the-counter status, the product will be pulled from shelves and drugmakers will have to change their formulas.
The agency is expected to decide on whether to revoke the ingredient's OTC label, but the FDA has not declared when it will make its final decision.