FDA to Phase Out Ineffective Phenylephrine, Shifting Focus to Reliable Cold Remedies
December 23, 2024U.S. officials are taking steps to phase out phenylephrine, a common decongestant in over-the-counter medications, after determining it does not effectively relieve nasal congestion.
This decision follows a unanimous vote by federal advisers in 2023, which was influenced by recent studies and earlier flawed research from the 1960s and 1970s.
Despite the impending changes, current regulations allow oral phenylephrine medications to remain available during a lengthy review process that includes public comment and potential product reformulation.
Experts explain that phenylephrine is ineffective when taken orally because it is rapidly broken down in the stomach, preventing it from entering the bloodstream.
Phenylephrine became the go-to decongestant after pseudoephedrine was moved behind pharmacy counters in 2006 due to its potential misuse in methamphetamine production.
Experts maintain that ineffective options like phenylephrine do not constitute real choices for consumers, despite arguments from industry advocates.
Concerns about phenylephrine's efficacy have been raised since 2007 by researchers, including those from the University of Florida, prompting petitions to the FDA in 2007 and 2015.
Doctors believe that eliminating phenylephrine will help consumers choose more effective alternatives for treating cold, flu, fever, and allergies.
Even higher doses of phenylephrine have proven ineffective and could pose safety risks, such as elevated blood pressure.
The Consumer Healthcare Products Association argues for the continued availability of phenylephrine, claiming consumers should have access to all products, even those that may not be effective.
Nasal steroids like Flonase and Nasacort are recommended for long-term relief, but they require daily use, while antihistamine sprays can offer quicker short-term relief.
The FDA's actions represent a significant victory for researchers who have long questioned the effectiveness of phenylephrine.
Summary based on 11 sources
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Sources
Yahoo News • Dec 23, 2024
FDA says decongestant in many cold medicines doesn't work. So what does?Yahoo News • Dec 23, 2024
FDA says decongestant in many cold medicines doesn't work. So what does?AP News • Dec 23, 2024
FDA says decongestant in many cold medicines doesn't work. So what does?PBS News • Dec 23, 2024
FDA says decongestant in many cold medicines doesn't work. What does help?