FDA committee to consider whether ingredient in many popular decongestants actually works

The US Food and Drug Administration is re-evaluating the effectiveness of phenylephrine, a medication in many over-the-counter drug products that treat nasal and sinus congestion.

At a hearing Monday and Tuesday, the expert members of the FDA’s Nonprescription Drugs Advisory Committee are discussing the pill form of the drug, which is used in popular products like Benadryl Allergy Plus Congestion, Sudafed PE and Vicks Sinex. Phenylephrine is also used in some liquid and spray decongestants, but that form is not a part of this re-evaluation.

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 allergies prompt the body to send white blood cells to the nose, throat and sinuses, leading to swelling in the nasal membranes and the creation of mucus. Decongestants constrict the blood vessels in the sinuses and nose, reducing the swelling and helping fluids drain.

In pill form, some scientists say, phenylephrine gets absorbed by the gut and metabolized so well that only a tiny bit makes it to the bloodstream, where it is needed to reach the nose, according to the citizen petition that asks the FDA to pull the drug from store shelves. A citizen petition is a way for industry, consumer groups or individuals to petition the FDA to change regulations or take other administrative action.

In the briefing documents prepared for the FDA committee’s meeting this week, agency reviewers said that in looking at the evidence, “we have now come to the initial conclusion that orally administered PE [phenylephrine] is not effective as a nasal decongestant at the monographed dosage (10 mg of PE hydrochloride every 4 hours) as well as at doses up to 40 mg (dosed every 4 hours),”

If the FDA’s committee votes that this ingredient is not helpful for decongestant pills, the agency could decide to reclassify the ingredient, which is currently considered “Generally Recognized As Safe and Effective,” or GRASE.

When an ingredient is declared GRASE, drugmakers can add it to their products without having to go through an FDA approval process. If the FDA reclassifies phenylephrine, the ingredient would still be available, but the many over-the-counter tablets that use the ingredient may have to be taken off the shelf or reformulated.

Phenylephrine was approved by the FDA for over-the-counter use in the 1970s, but it became even more common after 2005, when legislation restricted access to OTC drugs that use a similar decongestant ingredient called pseudoephedrine.

Although medicines with pseudoephedrine were still considered over-the-counter, they began to be kept behind pharmacy counters because, in large quantities, pseudoephedrine can be used to make the illegal drug methamphetamine. Phenylephrine cannot be used to make meth.

Many doctors have questioned phenylephrine’s effectiveness for years. The same FDA committee meeting this week took a closer look at the science in 2007, including a meta-analysis that found that the ingredient “may be effective.” The committee called for more studies, including on the drug’s effectiveness at higher doses than the standard 10 to 40 milligrams. However, doses of 80 to 90 milligrams seemed to raise blood pressure, according to the FDA briefing documents.

Since that 2007 hearing, according to FDA briefing documents, three large clinical trials have shown that the orally administered ingredient is not effective as a decongestant in its typical dosage.

In 2015, University of Florida pharmacy professors Drs. Leslie Hendeles and Randy C. Hatton submitted a citizens petition to request that the FDA remove oral phenylephrine’s GRASE designation. The two had also submitted the petition that prompted the 2007 hearing.

A change to phenylephrine’s designation could be costly to manufacturers. The Consumer Healthcare Products Association, which represents makers of over-the-counter medicines and dietary supplements as well as consumer medical devices, opposes a change. The group says it urges the FDA panel “to recognize PE’s clear benefits and critical role in public health.”

The FDA committee’s briefing documents note that if the designation changed, there would need to be a concerted effort to educate the public about the decision, since so many people could see their preferred decongestants disappear from store shelves.

Dr. Zara Patel, director of endoscopic skull base surgery and a professor of otolaryngology at Stanford Medicine, said the public may be confused if they suddenly can’t find a product in stores. However, she said, they shouldn’t see it as a reason to distrust regulatory agencies.

“This is how science works. As we gain 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 does take action, people won’t get nervous and wonder whether the medicine they’ve been taking for years is actually unsafe. “It is the opposite case with this. It’s actually just not effective at the doses that is in these medications,” Patel said. “We wouldn’t want people to be taking something that has no benefit.”

It’s also important to note that the committee is not examining the effectiveness of sprays that use phenylephrine. These can be effective in the very short term, according to Dr. Brian D’Anza, a doctor at University Hospitals Health System in Cleveland who focuses on sinus and endoscopic skull base surgery.

“We do use it in our clinics as a way to decongest the nose in very short-term basis so we can look in there better, and sometimes we use it during surgery when we’re trying to stop the bleeding in the nose,” said D’Anza, who is not part of the FDA committee.

But the ingredient in the spray version works for only a short amount of time – usually 60 to 90 minutes – and then the effect can go away. It can also become addictive, and if used for a long period, it can damage nasal tissue.