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.
“At issue is phenylephrine, an almost-century-old ingredient in versions of Benadryl, Mucinex, Tylenol and other over-the-counter pills, syrups and liquids to clear up congested noses,” the Wall Street Journal reported. “Phenylephrine, first permitted for use in 1938, didn’t go through the rigorous clinical trials that regulators require today for medications, and more recent studies found the ingredient to be ineffective at relieving congestion. The latest research prompted pharmacists and physicians to call for ending the sales of the drugs.”
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.
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
Dr. Scott Gottlieb, a Pfizer board member, complained about the FDA’s findings on the social media platform X.
“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 cost,” he said.
But 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.
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.
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.”
“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 recently approved Covid “boosters” that were tested on eight lab rats.
. . . And yet another source of relief and/or comfort taken away from everyday people. We are slowly being backed into a corner with no relief in sight. Then push plenty of fear, and the people will give those in power anything and everything they want — including all the money and power they could ask for.