Doctors, pharmacists, and medical groups have asked FDA to stop the sale of decongestants with phenylephrine, citing multiple studies that suggest the ingredient does not actually relieve congestion, Jared Hopkins writes for the Wall Street Journal.
Phenylephrine is an ingredient used in medications intended to clear congestion from a cold, flu, or allergies. Currently, phenylephrine can be found in over 260 oral nose and sinus medications, including versions of Benadryl, Mucinex, and Tylenol, according to a 2020 study published in JAMA Otolaryngology–Head & Neck Surgery.
However, at least one company has tested the ingredient as a substitute for pseudoephedrine, which was restricted to be sold behind the pharmacy counter in 2006 because it can be used to make methamphetamine.
Schering-Plough—later acquired by Merck & Co.—which manufactured Claritin-D at the time, tested whether phenylephrine was an effective substitute for pseudoephedrine. According to published studies, the company determined that phenylephrine was ineffective, and continued using pseudoephedrine inClaritin-Dsold behind the pharmacy counter.
According to Leslie Hendeles and Randy Hatton, professors at the University of Florida's pharmacy school who evaluated research on phenylephrine drugs in the 2000s, their analysis revealed insufficient evidence to support phenylephrine's effectiveness.
Meanwhile, at least four randomly controlled studies have found that phenylephrine was not more effective at relieving congestion than a placebo. The studies were funded by Schering, then Merck, according to the Journal.
Merck funded the studies because it was considering bringing a decongestant to market, according to Eli Meltzer, an allergist who helped conduct research published in 2015 and 2016.
"Physicians and pharmacists say because oral phenylephrine is metabolized in the gut and liver, it can't reach the bloodstream in sufficient levels and cause the blood vessels to narrow and provide relief," Hopkins writes.
"The evidence is clear that oral phenylephrine does not work," said Hatton. "If it doesn't get into the blood in the first place, it can't go to the nose and cause nasal constriction and therefore relieve your congestion."
When asked to review the review the recent studies and their findings, Garret FitzGerald, a professor of translational medicine and therapeutics at the Perelman School of Medicine at the University of Pennsylvania, determined them to be credible.
Following these studies, doctors, pharmacists, and industry groups—including the American Academy of Allergy, Asthma and Immunology and the American College of Clinical Pharmacy—have argued the pills should not be sold.
"Why give something if it has no benefit?" Meltzer said. "It's a waste of money."
In 2015, University of Florida pharmacy researchers who reviewed testing of the pills filed a citizen's petition asking FDA to remove phenylephrine from its list of approved over-the-counter medicines.
The agency in 2016 told the researchers it was reviewing the request but was not able to reach a decision, claiming the petition "raises complex issues requiring extensive review and analysis." An agency spokesperson noted that federal law prohibits the public discussion of the filings.
According to Stefanie Ferreri, a professor at the University of North Carolina's Eshelman School of Pharmacy who has followed the issue but is not involved in the petition, FDA has likely not taken action because the issue poses a low risk of harm.
"It's not a safety concern so it's not a priority of the FDA," said Ferreri, who supports stopping the use of phenylephrine in decongestants.
However, the Consumer Healthcare Products Association (CHPA), an industry trade group, argued that the medicines should remain on the market. According to a CHPA spokesperson, FDA recognized that phenylephrine is safe and effective as an oral decongestant. In addition, the spokesperson noted that its member companies comply with federal regulations.
For instance, Johnson & Johnson (J&J), which manufactures Tylenol and Benadryl, said FDA recognizes phenylephrine as an ingredient that works safely. In addition, J&J noted that it evaluates the latest science, safety information, and regulatory information on each of its products.
Separately, Reckitt Benckiser Group PLC, which manufactures Mucinex, said it follows the federal regulations in all markets it operates within. (Hopkins, Wall Street Journal, 12/23/22)
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