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FDA Advisory Board Rules That Many Over-The-Counter Decongestants Really Don’t Work

by Precious Gibson
September 13, 2023
Reading Time: 1 min read
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FDA Advisory Board Rules That Many Over-The-Counter Decongestants Really Don't Work

Sudafed

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If you’ve taken an over-the-counter decongestant pill and noticed you didn’t feel better, it’s likely because it doesn’t work.

The Food and Drug Administration has dropped a bombshell regarding a common cold and allergy meds ingredient known as phenylephrine. This drug is found in many OTC pills, such as Sudafed, Nyquil, Dayquil, and Benadryl, to name a few. Phenylephrine is supposed to reduce swollen blood vessels in the nasal passages, which reduces congestion, NBC News explains.

On Monday, the panel of experts released the findings, which included placebo research, concluding that when taken orally, minimal amounts of phenylephrine actually reach the nasal cavity. FDA Advisory Committee member Susan Blalock declared the study was sufficient enough to determine these pills and syrups are virtually useless. Now, the agency must decide how to proceed with phenylephrine oral products. They can now choose to revoke the “safe and effective” stamp from drugs containing phenylephrine. Furthermore, the FDA could also decide whether or not phenylephrine will remain on the approved list of pill and liquid decongestants altogether. Since the advisory board’s recommendations are not the final say on the matter, it might take years to remove OTC medications containing the components from the market.

This isn’t the first time oral phenylephrine has been called into question. Multiple studies have found that the ingredient has no actual benefit for those who take it by pill or liquid, though in nasal spray form, it is more effective. However, throughout the years, the FDA has sought additional research.

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