The U.S. Food and Drug Administration is reevaluating the effectiveness of phenylephrine, a drug in many over-the-counter medications that treat nasal and sinus congestion.
At a hearing on Monday and Tuesday, expert members of the FDA’s Nonprescription Drug Advisory Committee are discussing the tablet form of the drug, which is used in popular products such as Benadryl Allergy Plus Congestion, Sudafed PE and Vicks Sinex. Phenylephrine is also used in some liquid and spray decongestants, but that form is not part of this reevaluation.
Phenylephrine 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 citizens’ petition to remove the drug’s over-the-counter status.
Phenylephrine works by temporarily reducing the swelling of blood vessels in the nasal passages. A respiratory infection or allergy causes the body to send white blood cells to the nose, throat, and sinuses, causing the nasal membranes to swell and create mucus. Decongestants constrict blood vessels in the sinuses and nose, reducing swelling and helping fluids drain.
In pill form, some scientists say, phenylephrine is absorbed from the intestine and metabolized so well that only a small amount reaches the bloodstream, where it is needed to reach the nose, according to the citizens’ petition asking the FDA to withdraw the medicine from store shelves. A citizen petition is a way for industry, consumer groups, or individuals to ask the FDA to change regulations or take other administrative action.
In briefing papers prepared for this week’s FDA committee meeting, agency reviewers said that by reviewing the evidence, we have now reached the initial conclusion that orally administered EP [phenylephrine] is not effective as a nasal decongestant in the monographed dosage (10 mg of PE hydrochloride every 4 hours), as well as in doses of up to 40 mg (administered every 4 hours),
If the FDA committee votes that this ingredient is not useful in decongestant pills, the agency may decide to reclassify the ingredient, which is currently considered Generally Recognized as Safe and Effective, or GRASE.
When an ingredient is declared GRASE, drug manufacturers can add it to their products without having to go through an FDA approval process. If the FDA reclassifies phenylephrine, the ingredient will still be available, but the many over-the-counter pills that use the ingredient may have to be pulled from the shelf or reformulated.
Phenylephrine was approved by the FDA for over-the-counter use in the 1970s, but became even more common after 2005, when legislation restricted access to OTC medications that use a similar decongestant ingredient called pseudoephedrine.
Although pseudoephedrine medications were still considered over-the-counter, they began to be stocked on pharmacy counters because, in large quantities, pseudoephedrine can be used to manufacture the illegal drug methamphetamine. Phenylephrine cannot be used to make methamphetamine.
Many doctors have questioned the effectiveness of phenylephrines for years. The same FDA committee meeting this week took a closer look at the science in 2007, including a meta-analysis that found the ingredient may be effective. The committee called for more studies, including on the effectiveness of drugs at higher doses than the standard 10 to 40 milligrams. However, doses of 80 to 90 milligrams appeared to increase blood pressure, according to FDA briefing documents.
Since that 2007 hearing, according to FDA briefing documents, three large clinical trials have demonstrated that the orally administered ingredient is not effective as a decongestant at its typical dosage.
In 2015, pharmacy professors at the University of Florida Drs. Leslie Hendeles and Randy C. Hatton filed a citizen petition to request that the FDA remove the GRASE designation from oral phenylephrines. The two also presented the petition that led to the 2007 hearing.
A change in the name of phenylephrines could cost manufacturers dearly. The Consumer Healthcare Products Association, which represents manufacturers of over-the-counter drugs and dietary supplements as well as consumer medical devices, opposes a change. The group says it urges the FDA panel to recognize the clear benefits and critical role of PEs in public health.
FDA committee briefing documents note that if the designation were to change, there would need to be a concerted effort to educate the public about the decision, as many people could see their favorite decongestants disappear from store shelves.
Zara Patel, director of endoscopic skull base surgery and professor of otolaryngology at Stanford Medicine, said the public can become confused if they suddenly can’t find a product in stores. However, she said, they should not see this as a reason to distrust regulatory agencies.
This is how science works. As we get more information, recommendations may change, and that’s not a bad thing. That’s the wonderful thing about science. We can use new information and change our perspective, said Patel, who is not affiliated with the FDA committee.
She hopes that if the FDA takes action, people won’t get nervous and wonder if the medicine they’ve been taking for years is really unsafe. It’s the opposite case of that. In fact, it’s simply not effective at the doses of these medications, Patel said. We wouldn’t want people to take something that doesn’t provide any benefit.
It is also important to note that the committee is not examining the effectiveness of sprays that use phenylephrine. They can be effective in the very short term, according to Dr. Brian DAnza, a physician at University Hospitals Health System in Cleveland who focuses on endoscopic skull base and sinus surgery.
We use it in our clinics as a short-term way to decongest the nose so we can look better, and we sometimes use it during surgery when we’re trying to stop nosebleeds, said DAnza, who is not on the hospital committee. FDA.
But the ingredient in the spray version only works for a short time, usually 60 to 90 minutes, and then the effect may wear off. It can also become addictive and, if used for a long time, can damage nasal tissue.
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