By Aliyah Siddiqui
Nation and World Editor
A common ingredient used to treat decongestion in many cold syrups has been announced as ineffective, according to a panel of experts. According to many studies, the ingredient, phenylephrine, works just as well as a placebo when taken in its oral or liquid form.
“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” said Dr. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine who was on the panel.
Phenylephrine became a popular ingredient in over-the-counter decongestants after another ingredient, pseudoephedrine, was banned in 2006 as it was often illegally converted into methamphetamine. Other alternatives, such as phenylpropanolamine, were also banned by the FDA due to its association with brain bleeds, leaving phenylephrine as the main contender for decongestants. According to AP, phenylephrine-containing oral decongestants make up 80% of the market.
Besides last week’s review, there have been numerous questions in the past about the effectiveness of phenylephrine. In 2007, University of Florida researchers questioned the efficacy, telling the FDA that more evidence was necessary to conclude that it worked. They also questioned whether it would be more effective at higher dosages; this increase, however, can not be implemented due to its relationship with increasing blood pressure.
It is also important to note, however, that phenylephrine is only ineffective in oral (tablet) or liquid form; it still works as a decongestant in nasal sprays. According to the New York Times, this difference in efficacy is due to the fact that phenylephrine is destroyed in the stomach after being ingested, preventing the medicine from reaching the bloodstream and nose in oral/liquid forms.
As a result of the FDA panel’s findings, there have been lawsuits against corporations, including Proctor and Gamble, Walgreens and Kenvue, for misleading consumers on the efficiency of phenylephrine. As reported by Reuters, the suit claims that the corporations knew by 2018 that marketing claims regarding phenylephrine were false but still continued to deceive consumers.
Although the drug has been ruled ineffective, the FDA still needs to decide whether it will remain on the market. According to ABC, this decision will take a while, but members of the FDA advisory committee mentioned concerns about keeping the drug on the market, including patients having the burden of paying for a drug that does not work or forgoing more reliable treatments.
Pharmaceuticals also advise caution before removing products from shelves. In a public statement, the Consumer Healthcare Products Association, which represents manufacturers of over-the-counter-drugs, commented on the announcement.
"We encourage FDA, before making any regulatory determination, to be mindful of the totality of the evidence supporting this long-standing OTC ingredient, as well as the significantly negative unintended consequences associated with any potential change in oral PE's regulatory status," Scott Melville, president of CHPA, said.
The FDA is currently seeking public comment to decide whether products with phenylephrine should be removed from stores.
