Officials with the Food and Drug Administration (FDA) announced Tuesday that one of America’s leading cold medicines doesn’t actually work, following a review of the latest research on the subject.
Advisers to the FDA unanimously determined that phenylephrine, a decongestant found in most cold and allergy medicines such as Sudafed PE, Allegra and Dayquil was essentially no better in providing relief than a dummy pill, the Associated Press (AP) reported.
“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” Dr. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine, told the outlet.
Advisory committee member Susan Blalock added that the evidence is “pretty compelling that this medication is not effective,” adding that she didn’t believe additional data was needed to support the conclusion, according to NBC News.
This is a shame. At FDA we looked closely at this question in 2003 when pseudoephedrine was forced behind the counter, concluding phenylephrine was active. Now cold sufferers may have even fewer accessible options, driving up healthcare costs1/2 https://t.co/j80oyr2Hoy
— Scott Gottlieb, MD (@ScottGottliebMD) September 12, 2023
Phenylephrine began showing up in OTC cold medications beginning in the early 2000s as a replacement for pseudoephedrine, the decongestant used in Sudafed, which is used as an ingredient to make methamphetamine, NBC News reported.
The advisory committee’s conclusion follows a two-day meeting that was prompted by researchers with the University of Florida, who petitioned the FDA to remove phenylephrine products on the basis of recent studies that showed the drug failed to outperform placebo pills in patients with cold and allergy congestion, the AP reported. Though these same researchers made a similar challenge to the FDA in 2007 regarding the effectiveness of phenylephrine, the FDA allowed products containing the decongestant to continue to be sold, pending further research, the outlet stated. (RELATED: FDA Documents Confirm Top Scientists Were Frustrated Over CDC Ramming Through Boosters)
Three large studies conducted by Merck and Johnson & Johnson since 2016 “showed no difference between phenylephrine medications and placebos for relieving congestion” in hundred of patients, the AP reported.
Furthermore, studies that gained phenylephrine its original approval in the 1960s and 1970s were found to be flawed and “extremely small,” using “statistical and research techniques no longer accepted by the agency,” regulators said, according to The AP.
“This drug and this oral dose should have been removed from the market a long time ago,” patient representative Jennifer Schwartzott, stated, according to the outlet. “The patient community requires and deserves medications that treat their symptoms safely and effectively and I don’t believe that this medication does.”
Following the advisory committee’s unanimous determination, the FDA will now be required to decide whether to strip all over-the-counter (OTC) medications containing the drug of their “safe and effective” labeling. Without such a label, any product containing phenylephrine could possibly be removed from store shelves or manufacturers may need to develop new formulas, the outlet stated.
The FDA has not indicated when it will make its decision on the matter, though it usually sides with its advisory committee’s recommendations, NBC News reported.