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FDA wants to pull decongestant found in many cold, allergy medicines

By Megan Ziegler
Published  November 10, 2024 10:34am PST
Health
FOX TV Digital Team
article

FILE - A bottle of Vicks DayQuill cold and flu medicine containing phenylephrine is displayed for sale in a CVS Pharmacy store in Hawthorne, California on September 12, 2023. (Photo by Patrick T. Fallon/ AFP via Getty Images)

The Brief

    • The FDA is proposing ending use of a popular nasal decongestant, phenylephrine, in oral form. 
    • The FDA’s proposal is based on effectiveness concerns, not safety concerns.
    • Phenylephrine is an active ingredient in many pill and liquid medications, but also can be taken in other forms, in which its effectiveness is not under review. 

The U.S. Food and Drug Administration this month announced its proposal to remove a popular decongestant found in many over-the-counter medications from shelves. 

The decongestant in question is phenylephrine, which is found in popular cough and cold products, including Benadryl Allergy Plus Congestion, Sudafed PE Sinus Congestion and Vick's DayQuil. 

The reason for the FDA’s proposal isn’t due to safety, but, rather, over the ongoing concern that the drug isn’t effective when taken in oral form. 

Here is what to know about it: 

What is phenylephrine?

Phenylephrine has been used for temporary relief of nasal congestion since being approved by federal health regulators in 1976. 

By 2006, it became the main ingredient in many over-the-counter medicines, replacing the older ingredient pseudoephedrine, which was moved behind counters because it could be processed into methamphetamine. 

Some products contain only oral phenylephrine as a single, active ingredient, while others contain oral phenylephrine and another active ingredient, such as acetaminophen or dextromethorphan.

"The presence of oral phenylephrine in these medicines does not affect how other active ingredients work to treat the symptoms for which they are intended," the FDA noted.

Why is phenylephrine under review?

The effectiveness of phenylephrine when taken as a pill or liquid has been questioned for some time. 

Studies conducted in the past few years by the drugmakers Merck and Johnson & Johnson have shown no difference between phenylephrine medications and placebos for relieving congestion, according to The Associated Press. 

As such, last year, CVS Health pulled from its shelves oral decongestants that contained phenylephrine as the only active ingredient. 

"Think of it almost like a useless drug that's sitting in there," Dr. Dipak Chandy, who is with New York's Westchester Medical Center, told FOX Business in 2023 when CVS was removing the products. "It's doing nothing, and it's doing no harm. It's doing no good. … It's really a completely pointless drug that's mixed in with a bunch of other medications."

READ MORE: CVS pulls popular cold medicines from store shelves

The FDA said the drug appears more effective when applied directly to the nose, in sprays or drops. Those products are not under review.

The Consumer Healthcare Products Association said last week it was disappointed in the FDA’s latest proposal to remove oral phenylephrine from shelves.

"We believe Americans deserve access to safe and effective OTC medicines and the option to choose the products they prefer for self-care," their statement read, in part.