The FDA focused the debate on nasal decongestants for oral use.
A popular ingredient in many over-the-counter medications that promise relief from nasal congestion caused by allergies and colds is ineffective in tablet form. This was determined by an independent advisory committee of the US Food and Drug Administration (FDA).
While the medications are safe to use, the effectiveness of phenylephrine, which is found in products such as Benadryl Allergy Plus Congestion, Sudafed PE and Vicks Sinex, has been questioned.
That’s why the FDA’s Nonprescription Drug Advisory Committee decided to spend two days debating the ingredient’s effectiveness earlier this week. When asked, “Do current scientific data support that oral administration of a monographic dose of phenylephrine is effective as a nasal decongestant?”, the 16 experts who make up the team answered “No.”
Phenylephrine was approved by the FDA for over-the-counter use in the 1970s, but became more widely used after 2005, when U.S. legislation restricted access to over-the-counter medications that use a similar decongestant called pseudoephedrine.
Although it is available in various forms, including liquids, pills and nasal sprays, the organization focused on oral formulations. Since 2007, the FDA had classified phenylephrine as an ingredient that “may be effective,” but at the time called for further research.
After the committee meeting earlier this week, the team concluded that the issue did not require further investigation.