According to research, phenylephrine is ineffective
According to research, phenylephrine is ineffective against allergies and colds; this compound is in many popular medications.
Phenylephrine is a popular ingredient in many over-the-counter allergy and cold medications, and according to research from the Food and Drug Administration (FDA), it is not effective.
This was confirmed on Tuesday, September 12th, by an independent advisory committee of the U.S. Food and Drug Administration, better known as the FDA.
Phenylephrine is the primary ingredient used in products such as Benadryl Allergy Plus Congestion, Sudafed PE, and Vicks Sinex.
Based on the study, phenylephrine is ineffective and has no effect on those affected by colds or allergies.
The ingredient is considered safe to use; that was not up for debate, but many doctors have questioned the efficacy of phenylephrine for years.
These products generated nearly $1.8 billion in sales just last year, according to FDA data presented to the Over-the-Counter Drug Advisory Committee during the two-day committee meeting.
On Tuesday, the committee unanimously voted on the specific question, “Do you support the current scientific data presented that the monograph dose of orally administered phenylephrine is effective as a nasal decongestant?” The vote was unanimous among its 16 members, and the committee agreed that the issue does not need further study.
“We really shouldn’t have products on the market that are not effective,” said committee member Diane Ginsburg, a specialist from the University of Texas at Austin’s College of Pharmacy.
The FDA told the committee that it would take their advice into consideration but did not provide a timeline.
If the agency decides to reclassify phenylephrine from “Generally Recognized as Safe and Effective” (GRASE), stakeholders would have the opportunity to comment on the proposed change and provide any additional data.
During that process, companies could still market products with phenylephrine.
Phenylephrine is ineffective
Now, the debate arises: since phenylephrine is ineffective, what will pharmacies do, and most importantly, what will consumers do? But if the FDA agrees with the committee, companies may be required to remove phenylephrine products from store shelves or reformulate them.
The agency approved phenylephrine for over-the-counter use in the 1970s but became even more common after 2005.
However, after legislation restricted access to over-the-counter medications using a similar decongestant ingredient called pseudoephedrine, phenylephrine saw increased consumption.
Studies conducted since then, including three large clinical trials, have shown that the orally administered ingredient is not effective as a decongestant in its typical dose.
Phenylephrine is ineffective and is considered the most common ingredient in over-the-counter oral, nasal, and sinus products, according to the American Academy of Allergy, Asthma, and Immunology.
Last year, the group supported a citizen petition to remove its over-the-counter status.
Phenylephrine works by temporarily reducing the inflammation of blood vessels in the nasal passages.
A respiratory infection or allergies cause the body to send white blood cells to the nose, throat, and nasal sinuses, leading to swelling of the nasal membranes and mucus production.
Decongestants constrict the blood vessels in the nasal sinuses and the nose, reducing swelling and helping to drain fluids.
In pill form, some scientists say phenylephrine is absorbed in the gut and metabolized so effectively that only a small amount reaches the bloodstream.
If phenylephrine is no longer available, there are other over-the-counter options, including nasal spray antihistamines, nasal corticosteroids, nasal saline products, and tablets with pseudoephedrine.
