September 15, 2023
A U.S. Food and Drug Administration panel has concluded that a common decongestant does not effectively relieve cold and allergy symptoms, setting up a possible recall of many popular medicines.
Phenylephrine is designed to constrict blood vessels in the nose to decrease congestion, and is found in products from Sudafed, Mucinex, NyQuil and Tylenol. Though it's been used for decades, the FDA said on Tuesday that research indicates the ingredient does not provide significant relief — meaning that while it is not harmful, it doesn't really work.
The FDA noted that evidence of phenylephrine's efficacy was mostly based on studies from 40 years ago, with sample sizes of less than 200 people. A review of more recent and robust research suggested that the decongestant, when administered orally, was no different than a placebo, since very small amounts of the ingredient actually reach the nose.
"When we look at the pharmacokinetics or how it's available in the body, at the current dosages, there's literature that says it should not really work for nasal decongestion," said Dr. Gurston Nyquist, an ENT doctor with Jefferson Health. "So its bioavailability is low and the concentrations in the blood are not high enough that it would support it causing decongestion of the nose or nasal constriction of the blood vessels in the nose."
In a unanimous vote, the FDA advisory committee said phenylephrine was ineffective when administered orally. Though the vote itself has no immediate impact on phenylephrine, it could lead to an FDA order to remove the ingredient from over-the-counter medicines. This would be a significant disruption in pharmaceuticals, since products containing phenylephrine brought in $1.8 billion in sales last year.
Dr. Nyquist expects it to happen.
"I do think that it's likely, considering all the members of the FDA voted that it didn't show efficacy," he said. "When they vote that way, it's most likely that the FDA will follow that ruling."
In a statement published Thursday, the FDA emphasized that there are no known safety issues with phenylephrine and that it had not made a final decision. Nasal sprays containing the decongestant, the FDA added, were not found to be ineffective.
But there are other medicines on the market, like Afrin, with alternative ingredients that serve as decongestants. Pseudoephedrine, found in Sudafed and other drugs, is highly effective as a decongestant, but it is sold "behind the counter," meaning it does not require a prescription, but people must request it from a pharmacist.
Anti-inflammatories containing acetaminophen, such as Tylenol, can help reduce any aches or fever while the antihistamines found in Claritin and Benadryl can provide allergy relief.
However, Nyquist emphasized that nasal decongestants are not recommended for long-term use, since they can worsen symptoms after three or four days. People who are still feeling stuffy can consult a doctor or try a saline rinse.
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