2023-09-13 19:14:11
The FDA focused debate on nasal decongestants for oral use.
A popular ingredient in many over-the-counter medications that promise to relieve nasal congestion from allergies and colds is ineffective in tablet form. This was stated by an independent advisory committee of the United States Food and Drug Administration (FDA).
While the medications are safe to use, the effectiveness of phenylephrine, present in products such as Benadryl Allergy Plus Congestion, Sudafed PE and Vicks Sinex, had been called into question. (Read: The two updated vaccines against covid-19 that were approved in the United States)
For this reason, the FDA’s Nonprescription Drug Advisory Committee decided to debate the effectiveness of the ingredient for two days earlier this week. When asked “Does the current scientific data presented support that the monographic dose of phenylephrine administered orally is effective as a nasal decongestant?”, the 16 experts that make up the team answered no.
Phenylephrine was approved by the FDA for over-the-counter use in the 1970s, but became more common after 2005, when U.S. legislation restricted access to over-the-counter medications that use a similar decongestant ingredient called pseudoephedrine. (Read: Colombia, the ninth country where the most cosmetic surgeries are performed in the world)
Although it comes in different 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 that time it called for more research.
After the committee that was held earlier in the week, the team determined that the issue does not need to be studied further.
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