The Ineffectiveness of Phenylephrine in Decongestants
Government experts have determined that the leading decongestant used by millions of Americans, which contains phenylephrine, offers no relief for a stuffy nose. The drug ingredient has long been questioned for its effectiveness, and advisers to the Food and Drug Administration (FDA) unanimously voted against it.
Dr. Mark Dykewicz, an allergy specialist, stated that modern studies show no improvement in congestion with phenylephrine when conducted properly. The FDA convened its outside advisers to reevaluate phenylephrine, which became the primary drug in over-the-counter decongestants after medicines containing pseudoephedrine were moved behind pharmacy counters.
Pseudoephedrine had to be moved due to its potential for being illegally processed into methamphetamine. Although the original versions of decongestants containing pseudoephedrine are still available without a prescription, they account for only about one-fifth of the market. Phenylephrine versions, labeled as “PE” on packaging, comprise the remaining majority.
If the FDA follows the panel’s recommendations, manufacturers such as Johnson & Johnson and Bayer may need to remove their oral medications containing phenylephrine from store shelves. This could result in consumers switching to behind-the-counter pseudoephedrine products or phenylephrine-based nasal sprays and drops.
The FDA would need to collaborate with drugstores, pharmacists, and other healthcare providers to educate consumers on the remaining options for treating congestion if this occurs.
Furthermore, the panel informed the FDA that studying phenylephrine at higher doses was not possible due to the risk of dangerously elevated blood pressure. Dr. Paul Pisaric of Archwell Health in Oklahoma expressed concern about safety and concluded that phenylephrine did not work as a decongestant.
The FDA was prompted to hold this meeting by University of Florida researchers who petitioned for the removal of most phenylephrine products. Recent studies indicated that these products did not outperform placebo pills in patients with cold and allergy congestion. Similar challenges to the drug’s effectiveness were made in 2007, but the FDA allowed the products to remain on the market pending further research.
This time, the FDA’s panel unanimously agreed that there is no evidence to support the effectiveness of phenylephrine as a decongestant. The FDA’s scientific review published before the meeting supported this conclusion and identified multiple flaws in the studies conducted in the 1960s and 1970s that initially approved phenylephrine.
The studies were deemed “extremely small” and employed statistical and research techniques that are no longer acceptable. Three larger, rigorously conducted studies published since 2016 also showed no difference between phenylephrine medications and placebos for relieving congestion.
A trade group representing nonprescription drugmakers argued that the new studies had limitations and advocated for continued access to phenylephrine. However, the FDA reviewers believe that their latest assessment reflects new insights into how phenylephrine is metabolized when taken orally, rendered largely ineffective in relieving congestion.
The FDA has the authority to remove phenylephrine from the list of effective decongestants for over-the-counter pills and liquids. Doing so would eliminate unnecessary costs and delays in care associated with using a drug with no benefit. The process for changing the FDA’s nasal decongestants drug list, or monograph, has been expedited by a law passed in 2020, allowing for quicker updates on nonprescription ingredients.
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