FDA advisory committee says common ingredient in some nasal decongestants does not work
On Tuesday, a U.S. Food and Drug Administration advisory committee voted unanimously that the oral formulation of a very common nasal decongestant, phenylephrine, is not effective. The decision could lead to this formulation of the drug being taken off the market, but the FDA says nothing has changed yet.
Phenylephrine is found in some forms of over-the-counter medications like Dayquil, Mucinex and Sudafed PE.
"It's amazing the amount of dollars being spent on something that really has no efficacy," William Figg, Pharm.D., from the National Cancer Institute, said during the committee meeting.
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."
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.
Now that the committee has ruled this formulation is ineffective in treating nasal congestion, the FDA will need to decide if it stays on the market.
A spokesperson from the FDA tells ABC News there are several steps that would need to happen before this drug is taken off the market, during which time the marketing status of oral phenylephrine would not change. They did not have any further information on the timing of such a decision at this time.
In a statement on Thursday, the FDA said “advisory committees provide independent advice and recommendations to FDA, but the agency makes the final decision. FDA will consider the input of this advisory committee, and the evidence, before taking any action on the status of oral phenylephrine.”
In a public statement Tuesday, the Consumer Healthcare Products Association, which represents manufacturers of over-the-counter-drugs, called the decision "disappointing."
"We encourage FDA, before making any regulatory determination, to be mindful of the totality of the evidence supporting this long-standing OTC ingredient, as well as the significantly negative unintended consequences associated with any potential change in oral PE's regulatory status," CHPA president and CEO Scott Melville said in the statement.
He added, "We look forward to working with FDA in the coming days to further discuss how to best move forward in the interest of patients and consumers."
The FDA said previously in its briefing documents that it was 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.
In Tuesday's advisory committee meeting, some members stated that they believed keeping the ineffective drug on the market would be unsafe for consumers because it does not work and that could inadvertently cause harm if consumers continue to use this product instead of more effective treatments.
"Poor efficacy really is a safety issue for delayed treatment … because patients are getting the wrong thing and it's preventing them from getting the right thing," Dr. Stephen Clement from INOVA Fairfax Hospital in Falls Church, Virginia, said in the meeting.
Most of the advisory committee said they did not believe that further studies at higher dosages would be safe or effective, citing cardiovascular side effect concerns.
The FDA advisory committee's ruling is specific to the oral form of the drug. 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.
On Oct. 19, the FDA released a new statement.
"If the FDA determines that oral phenylephrine is no longer considered generally recognized as safe and effective (GRASE) under the conditions of use in OTC Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC Human Use (OTC Monograph M012), the FDA would issue a proposed order to amend OTC Monograph M012by removing oral phenylephrine as a GRASE active ingredient from that monograph. Stakeholders would have the opportunity to comment on the proposed order, including by providing additional data. During this time period, the marketing status of oral phenylephrine would not change. After considering all of the comments on the proposed order, the FDA would issue a final order on the GRASE status of oral phenylephrine for use as a nasal decongestant under the conditions of use in OTC Monograph M012," the statement read.
"The FDA has no further information to provide at this time regarding the timing of any decision the agency may make following the advisory committee meeting," the statement concluded.
Dr. Jade A Cobern, M.D., MPH is a licensed and practicing physician and a member of the ABC News Medical Unit.
