FDA Panel Says Common Over-The-Counter Decongestant Doesn’t Actually Work



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An advisory panel at the Food and Drug Administration concluded on Tuesday that a common over-the-counter decongestant is no more effective than a placebo when taken orally.
Phenylephrine, a common ingredient in cold and allergy medicines that is supposed to alleviate nasal congestion, simply doesn’t do the job when taken orally, even at doses well above recommended, according the latest review of more than a dozen studies and trials.
The drug is the most popular oral decongestant in the U.S., found in medications including Benadryl Allergy Plus Congestion and Sudafed PE, generating nearly $1.8 billion in sales last year, according to the FDA.
The drug is still effective in its nasal spray form, according to the agency. The drug is meant to work by temporarily constricting blood vessels, and the data presented at a meeting this week showed that when taken orally, not enough of the active drug reaches its target, referred to as bioavailability.
When the drug was originally declared effective, an FDA panel reviewed the data for oral doses between 5 mg and 40 mg across 14 studies. The current panel noted that 11 of those were sponsored on behalf of a single drug manufacturer. The current panel also noted that the “science has since evolved” and that those evaluations used an outdated methodology.
The current panel looked at three large, “adequately controlled” trials conducted after 2007, and determined that the efficacy of PE was not significantly different from that of a placebo.
“We have now come to the initial conclusion that orally administered PE is not effective as a nasal decongestant,” the advisory panel stated in its report.
Phenylephrine, or PE, took over the market in the early 2000s when pseudoephedrine, the decongestant in Sudafed, was moved behind the pharmacy counter to prevent its use as an ingredient in illegal methamphetamine.
If the FDA follow’s the panel’s recommendation and revokes PE’s status as “generally recognized as safe and effective,” many common cold and allergy products could disappear from store shelves.
The FDA advisory panel noted that education would be required to remind people that pseudoephedrine is still available to consumers from pharmacists upon request.
TMX contributed to this article.