FDA Panel Says a Common Cold Medicines’ Decongestant Does Not Work, Here’s Why

If you’ve noticed lately that you still feel congested after taking a decongestant, there could be a valid reason for that.

On Tuesday, an advisory panel of the Food and Drug Administration (FDA) released new findings that reveal that one of the key ingredients found in many over-the-counter health products does not relieve congested individuals after all.

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Phenylephrine — commonly found in over-the-counter medications used to treat nasal congestion — is now considered ineffective. The ingredient has been touted as a decongestant to treat stuffy noses, sinus congestion, and pressure.

It was also previously believed to reduce the swelling of blood vessels in the nasal passages.

“It has poor oral bioavailability due to extensive first-pass metabolism in the gut and liver,” reports The Journal of Allergy and Clinical Immunology.

Cold medicine.

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The findings came unanimously after a vote and the discovery could reshape the over-the-counter healthcare industry as we know it, NBC News reported.

According to The New York Times, the FDA will likely have to make a decision whether to remove ineffective products or ban them. The media noted that the process could take months, even longer if the results are disputed.

In the United States, some of the most commonly used brands that list phenylephrine as the active ingredient include Sudafed PE, Vicks Nyquil Sinex Nighttime Sinus Relief, and Benadryl Allergy Plus Congestion.

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Combined, the drugs made nearly $1.8 billion last year, CNN added, citing data released Monday by the Over-the-Counter Drug Advisory Committee during a two-day meeting.

Susan Blalock, a retired professor at the UNC Eshelman School of Pharmacy in North Carolina, is a board member and spoke out after the information was made public.

The evidence is “pretty convincing that this drug is not effective. I don’t think additional data is needed to support that conclusion,” Blalock said.

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“I think we obviously have better options over the counter to help our patients, and the studies don’t show that this is an effective drug,” Maria Coyle, panel chair and associate professor of pharmacy at Ohio State University, added.

dr. Leslie Hendeles, a pharmacist at the University of Florida in Gainesville, added, “If you have a stuffy nose and you take this medicine, you’re still going to have a stuffy nose.”

In 2007, the pharmacist and some of her colleagues asked pharmaceutical companies to stop producing products with phenylephrine.

However, earlier this year, the Consumer Healthcare Products Association agreed to continue selling drugs with the ingredient.

Pharmacy.

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“Phenylephrine has been used safely and effectively as a nasal decongestant in American families for generations, and FDA regulations recognize it as safe and effective,” they said in a statement in March.

In light of Tuesday’s revelations, many in the healthcare industry unequivocally disagree.

“We really shouldn’t have products on the market that aren’t effective,” said committee member Dr. Diane Ginsburg of the University of Texas at Austin College of Pharmacy.

NBC News added that when it comes to information collected through two decades of research conducted in five different studies, the results found that phenylephrine taken orally had no greater effect on subjects than a placebo.

Categories: Trends
Source: HIS Education