FDA panel to reevaluate the most common over-the-counter decongestant, phenylephrine, criticized as useless

The Meals and Drug Administration plans to ask a panel of its exterior advisers to rethink whether or not the most common decongestant ingredient out there over the counter, phenylephrine, is efficient. 

There was a renewed petition to drag it from retailer cabinets over research displaying it was no more practical than a placebo in drugs and syrups. 

The April meeting of the FDA’s Nonprescription Medicine Advisory Committee will weigh whether or not the company ought to revoke oral phenylephrine’s classification as “Usually Acknowledged as Secure and Efficient” as a result of it might be ineffective.

That would pave the way in which for the FDA to upend the marketplace for these over-the-counter congestion treatments, undoing a 2007 meeting of the identical panel that had sided with proof suggesting it “could also be efficient” in its present formulation and calling for extra research of upper doses.

That adopted efforts to fight illegal manufacturing of methamphetamine, which moved treatments containing one other ingredient referred to as pseudoephedrine — utilized in medication like Johnson & Johnson’s Sudafed — behind pharmacy counters.

“Phenylephrine has been used safely and successfully as a nasal decongestant by American households for generations, and FDA rules acknowledge it as protected and efficient,” the Client Healthcare Merchandise Affiliation — an trade commerce group of over-the-counter drug producers — mentioned in an announcement Friday.

Earlier than the assembly in 2007, a meta-analysis from the group had concluded an oral dose of phenylephrine was efficient as a substitute for deal with congestion.

“CHPA members proceed to observe these rules. We acknowledge FDA can reevaluate the efficacy of lively components – as it’s right here,” the assertion added.

However in 2015, pharmacy professors Leslie Hendeles and Randy Hatton submitted a new petition calling on the FDA to drag the drug. 

Since their authentic petition that led to the 2007 assembly, they cited new knowledge discovering phenylephrine was no higher than a placebo and renewed criticism across the CHPA’s evaluation and a few “questionable” research underlying them.

“Let me be clear, oral phenylephrine will not be a security danger,” Hatton, a professor on the College of Florida, informed CBS Information. “It simply does not work.”

Hendeles and Hatton additionally penned a commentary in 2022 questioning the FDA’s inaction on their petition. The paper sparked renewed curiosity in scrutiny of the drug, described as  “useless” at reaching the bloodstream after being digested.

“I get it. Danger takes precedence. However eight years is lengthy sufficient to attend, you realize what I imply? That is hundreds of thousands and hundreds of thousands of {dollars} wasted on ineffective medication,” mentioned Hatton.

Hatton cited different medication which have higher knowledge supporting their efficacy at treating congestion. He additionally pointed to nasal spray types of phenylephrine that seem to work higher than their oral counterparts swallowed in capsules or syrups.

“Once you take it orally, it goes to the intestine. And because it’s being absorbed by way of the intestine, there are two enzymes that metabolize it to such an excellent extent that primarily a really miniscule quantity makes it into the bloodstream,” mentioned Hatton.

A statement in Might final 12 months from the American Academy of Allergy, Bronchial asthma & Immunology backed their petition. 

The group argued that retaining oral phenylephrine in over-the-counter medication “does a disservice to sufferers who could be liable to taking increased doses than really helpful” and unnecessarily delays docs visits for more practical prescriptions.

Hendeles declined to be interviewed till after his presentation on the FDA’s April assembly. The FDA didn’t instantly reply to a request for remark concerning the assembly.

Hatton says he usually makes use of oral phenylephrine as a case research of how over-the-counter medication are authorised within the U.S. when instructing college students on the college’s School of Pharmacy. 

“Lots of them work in trade. And those who’re pharmacists, I ask them, what have you ever heard from shoppers? And so they all say the identical factor: ‘Oh, everyone is aware of that does not work. Individuals complain on a regular basis, that does not work,'” mentioned Hatton.