FDA Finds Popular Decongestants Ineffective in Relief of Congestion
The FDA has made a significant determination regarding the effectiveness of phenylephrine, the main drug found in popular decongestants. After analyzing modern studies, the FDA’s outside advisers unanimously voted against the use of phenylephrine for congestion relief. This decision has implications for well-known over-the-counter medications such as Sudafed and Dayquil.
Phenylephrine became the primary ingredient in decongestants after the older ingredient, pseudoephedrine, was moved behind pharmacy counters due to its potential for illegal use. However, if the FDA follows through with the panel’s recommendations, pharmaceutical giants like Johnson & Johnson and Bayer may be required to remove their phenylephrine-based products from store shelves.
Consumers may be left with limited options for treating congestion, either having to switch to pseudoephedrine products or phenylephrine-based nasal sprays and drops. The FDA would work with drugstores, pharmacists, and other health providers to educate consumers on these remaining options for relief.
The recent research showing the ineffectiveness of phenylephrine was a driving force behind the FDA’s decision. Studies have revealed that phenylephrine failed to outperform placebo pills in patients with cold and allergy congestion. The FDA’s scientific review found flaws in the original studies from the 1960s and 1970s that supported phenylephrine’s approval. More recent, rigorously conducted studies since 2016 have consistently shown no difference between phenylephrine medications and placebos in relieving congestion.
Nonprescription drugmakers argue that the new studies have limitations and advocate for continued access to phenylephrine. However, the FDA’s latest assessment indicates that phenylephrine is metabolized quickly when taken orally, leaving only trace levels that reach nasal passages. The drug appears to be more effective when directly applied to the nose.
Although the FDA’s decision on phenylephrine’s effectiveness is not immediate, it sets the stage for potential removal from the federal list of effective decongestants for over-the-counter use. As further research and discussions take place, the future of popular decongestants hangs in the balance, leaving consumers and drugmakers awaiting the FDA’s final verdict.
