An advisory panel of the Food and Drug Administration (FDA) has recently concluded that most over-the-counter decongestants, specifically those containing the active ingredient phenylephrine, are ineffective in relieving nasal congestion.
This conclusion could potentially lead to such products being removed from store shelves across the nation. As patient advocate Jennifer Schwartzott stated, “This drug and this oral dose should have been removed from the market a long time ago… The patient community requires and deserves medications that treat their symptoms safely and effectively and I don’t believe that this medication does.”
The FDA panel analyzed the early documents and studies that supported phenylephrine’s over-the-counter (OTC) use. They found these studies to be inconsistent, lacking modern study design standards, or having flawed data integrity.
Dr. Peter Starke, an FDA official who led the review of phenylephrine, said, “In conclusion, we do believe that the original studies were methodologically unsound and do not match today’s standard…we believe the new data are credible and do not provide evidence that oral phenylephrine is effective as a nasal decongestant.”
Despite this, there has been industry opposition to the regulation of the drug. The Consumer Healthcare Products Association, an industry representative group, argued for keeping the drug available, citing the “totality of the scientific evidence” that supports efficacy. They criticized more recent clinical studies as having “important limitations” and being conducted on an inappropriate study population to evaluate the efficacy of phenylephrine for OTC use.
The group also shared a survey that revealed 1 in 2 households in the US used an oral decongestant over the past year. It also found that people prefer oral decongestant tablets over nasal sprays by 3 to 1.
The market for decongestants is significant: A consumer study of 100,000 US households showed that about half purchased medications with phenylephrine over the course of the year, and most did so several times a year.
Though the findings of the FDA advisory panel are nonbinding, the FDA usually sides with the panel, which may lead to oral phenylephrine products being removed from store shelves in the near future.
