FDA: Phenylephrine, key decongestant drug in Sudafed, Dayquil, not effective. What to know
Phenylephrine, the key drug used in leading decongestant brands such as Sudafed, Allegra and Dayquil, is nothing more than a placebo when taken orally, according to the latest research from a Food and Drug Administration panel.
Advisers to the FDA voted on Tuesday against the effectiveness of the drug, which became the main drug in over-the-counter decongestants when medicines with an older ingredient — pseudoephedrine — were moved behind pharmacy counters.
“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine, told the Associated Press.
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The Combat Methamphetamine Epidemic Act of 2005 banned over-the-counter sales of ephedrine, pseudoephedrine and phenylpropanolamine in 2006 because pseudoephedrine can be illegally processed into methamphetamine.
Drugmakers could be required to pull oral medications containing phenylephrine from store shelves if the FDA follows through on the panel’s recommendations.
Here’s what to know.
What is phenylephrine and what is it used for?
Phenylephrine is a key drug found in popular versions of Sudafed, Allegra, Dayquil and other medications that are used for temporary congestion relief caused by allergies, colds or sinus trouble.
What forms does phenylephrine come in?
Phenylephrine medications are available in oral liquid, tablets, chews, drops and nasal spray forms. Only oral variants may be impacted if the FDA follows through on the panel's recommendations.
What are phenylephrine brand names?
Oral versions of phenylephrine medicines can be found in Sudafed PE, Vicks Sinex, Benadryl Allergy Plus Congestion, Mucinex, Nyquil and more.
Phenylephrine found ineffective: Phenylephrine, the nasal decongestant in many cold medicines, found ineffective by FDA panel
Why the FDA panel says phenylephrine isn’t effective
Phenylephrine works by reducing the swelling of blood vessels in the nasal passages, but FDA reviewers said their latest assessment reflects new testing insights into how quickly phenylephrine is metabolized when taken by mouth, leaving only trace levels that reach nasal passages to relieve congestion.
The panel didn’t rule out phenylephrine’s effectiveness when applied directly to the nose in sprays or drops, but those products were not part of their review.
The new findings echo previous studies that show most phenylephrine products fail to outperform placebo pills in patients with cold and allergy congestion.
What are some phenylephrine decongestant alternatives?
Alternatives to phenylephrine-based decongestants are widely accessible, so the impact on consumers should be minimal. Antihistamines can be used to help congestion, and they’re safer for your cardiovascular health, according to the Harvard Medical School.
Nasal sprays also tend to be more effective at treating nasal congestion as the medicine is applied directly to the source of the problem. Nasal decongestants shouldn’t be used long-term, however.
Some pseudoephedrine-based medicines are also still available for purchase without a prescription. They can be purchased from behind the counter but have daily limits.
This article originally appeared on Pensacola News Journal: Phenylephrine decongestant alternatives? What to know after FDA panel
