FDA Advisory Committee questions the efficacy of nasal decongestant in products like Sudafed and Benadryl

Phenylephrine is used in over-the-counter medication like Sudafed PE Sinus Congestion and Benadryl Allergy Plus Congestion ULTRATABS.

Food and Drug Administration(FDA) Advisory Committee has questioned the effectiveness of nasal decongestant used in products like Sudafed and Benadryl. According to a report by The Hill, members of the committee voted against the oral use of phenylephrine as an effective nasal decongestant.

The U.S. Food and Drug Administration campus in Silver Spring, Maryland (AP)

Notably, phenylephrine is used in over-the-counter medication like Sudafed PE Sinus Congestion and Benadryl Allergy Plus Congestion ULTRATABS.

The FDA’s Nonprescription Drugs Advisory Committee consisted of 16 voting members in the meeting on Tuesday. All 16 members voted "no" on the question of whether scientific evidence supported the oral use of phenylephrine as an effective nasal decongestant.

Due to the latest developments in the committee's meeting, there is a possibility of removal of phenylephrine products from the market. Committee member Maryann Amirshahi opined that if it happens, it should be emphasised that it was “more of an efficacy issue as opposed to a safety issue.”

Earlier, academic journal "Science" had published an article in 2022 titled "The Uselessness of Phenylephrine". The article highlighted that oral phenylephrine is “extensively metabolized” in the gut. It also said that the standard 10 mg dose available over- the-counter has fairly low bioavailability.