FDA panel re-evaluates phenylephrine, the most common over-the-counter decongestant, which has been criticized as useless

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The Food and Drug Administration plans to ask a panel of outside advisers to reconsider its Most common decongestant ingredient Phenylephrine, available over the counter, is effective.

There have been renewed petitions to pull it from store shelves after studies found it was no more effective than a placebo in tablets and syrup.

An April meeting of the FDA’s Nonprescription Drugs Advisory Committee will consider whether the agency should rescind oral phenylephrine’s classification as “generally recognized as safe and effective” because of its ineffectiveness. It is possible

This could pave the way for the FDA to upend the market for these over-the-counter congestion remedies, canceling a 2007 meeting of the same panel that found it biased by the evidence that it “in its current formulation” can be effective” calling for more. High dose study.

This was followed by efforts to combat the illegal manufacture of methamphetamine, which moved treatments containing another ingredient called pseudoephedrine – used in drugs such as Johnson & Johnson’s Sudafed – behind pharmacy counters.

The Consumer Healthcare Products Association – an industry trade group of over-the-counter drug manufacturers – stated, “Phenylephrine has been used safely and effectively by American families for generations, and FDA regulations recognize it to be safe and effective.” ” a statement Friday.

Prior to the meeting in 2007, a meta-analysis by the group had concluded that a single oral dose of phenylephrine was effective as a treatment option for congestion.

“CHPA members continue to follow these rules. We acknowledge that the FDA may re-evaluate the efficacy of active ingredients – as it has here,” the statement said.

But in 2015, pharmacy professors Leslie Handels and Randy Hatton filed a new petition to the FDA to withdraw the drug.

Since their original petition that led to the 2007 meeting, they cited new data that found phenylephrine was no better than a placebo and renewed criticism surrounding the CHPA’s analysis and some “questionable” studies. .

“Let me be clear, oral phenylephrine is not a safety risk,” Hatton, a professor at the University of Florida, told CBS News. “It doesn’t work.”

Hendeles and Hatton also wrote a commentary in 2022 questioning the FDA’s inaction on their petition. The paper sparked renewed interest in investigating the drug, which has been described as “useless” in the bloodstream after being digested.

“I get it. Risk is prioritized. But eight years is a long time to wait, you know what I mean? Millions and millions of dollars wasted on ineffective drugs,” Hatton said.

Hatton cited other drugs that have better data supporting their efficacy in treating congestion. He also pointed to nasal spray forms of phenylephrine that seem to work better than their oral counterparts swallowed in capsules or syrup.

“When you take it orally, it goes into the gut. And since it’s being absorbed through the gut, there are two enzymes that metabolize it to such a large extent that essentially a very The smallest amount makes it into the bloodstream,” Hatton said.

In May last year, a statement from the American Academy of Allergy, Asthma and Immunology supported his plea.

The group argued that keeping oral phenylephrine in over-the-counter medications “causes a disservice to patients who may be prone to taking higher doses than recommended” and unnecessarily results in visits to doctors for more effective prescriptions. Let’s delay

Handels declined to be interviewed until after his presentation at the FDA’s April meeting. The FDA did not immediately respond to a request for comment regarding the meeting.

Hatton says he often uses oral phenylephrine as a case study for how over-the-counter drugs are approved in the US when teaching students in the University College of Pharmacy.

“Many of them work in industry. And I ask those who are pharmacists, what have you heard from consumers? And they all say the same thing: ‘Oh, everyone knows it doesn’t work. People Complains all the time.” , it doesn’t work,” Hatton said.

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