Effectiveness of common decongestant under review by FDA advisory committee - GMA

Beginning Monday, a U.S. Food and Drug Administration advisory committee is meeting to discuss the effectiveness of the oral formulation of a very common nasal decongestant, phenylephrine. The decision could lead to this formulation of the drug being taken off the market.

The ingredient under review is found in some forms of over-the-counter medications like Dayquil, Mucinex and Sudafed PE.

All over-the-counter medications hold a designation as "generally recognized as safe and effective" by the FDA, but clinical trials have found that oral phenylephrine, or PE, does not improve nasal congestion any more than a placebo at the dosage marked for over-the-counter use.

"There are certain studies that compare it to a placebo that don't show any discernible benefit," ABC News medical correspondent Dr. Darien Sutton told "Good Morning America." "The FDA advisory committee is going to meet, and there is a chance that they might say that this is no longer effective."

Experts first raised concerns about PE in 2007. Since then, more evidence has accumulated showing that the drug offers little to no relief for nasal congestion. This is believed to be because the drug is processed by the body before it reaches the nasal passages where it needs to work.

The committee will review the available data and vote on whether the evidence shows that oral PE is effective or not. Then, the FDA will need to decide if it stays on the market.

Walgreens pharmacy, over-the-counter medicine, cough, cold and flu relief.

Jeff Greenberg/Universal Images/Getty Images

In a public statement, the Consumer Healthcare Products Association, which represents manufacturers of over-the-counter-drugs, expressed concern that removing PE from the market could delay consumers from seeking care or may overburden the health care system by seeking treatment for a minor illness if adequate over-the-counter treatments cannot be accessed. The group said it "urge[s] the panel to be mindful of the significantly negative unintended consequences associated with removing PE from the OTC monograph."

The FDA said in its briefing documents that it is concerned about any unintended consequences for consumers of changing the status of oral PE, but that benefits could include "avoiding the unnecessary costs and delay in care of taking a drug that has no benefit" and "avoiding missed opportunities for use of more effective treatments."

While the drug's effectiveness is in question, the FDA has not raised any additional concerns about its safety. Known side effects including nervousness, jitteriness and sleeplessness, and it should be avoided or used with caution under the guidance of a doctor in people with certain health conditions including high blood pressure and glaucoma, according to the National Institutes of Health.

The FDA advisory committee's questions are specific to the oral form of the drug, and there are effective formulations of PE as a nasal decongestant when it is delivered through a nasal spray. But experts warn that over-using this drug can have a rebound effect that worsens nasal congestion.

Sutton said that when it comes to treating cold and flu symptoms like nasal congestion, sometimes less is more.

"I rarely advise patients to take these medications as mesmerizing as those as can be. I say stick to simple tactics."

Sutton recommends having a humidifier handy during dry months of the year, using nasal saline and staying hydrated.

Dr. Jade A Cobern, M.D., MPH is a licensed and practicing physician and a member of the ABC News Medical Unit.

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Effectiveness of common decongestant under review by FDA advisory committee - GMA
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