On Nov. 7, the U.S. Food and Drug Administration (FDA) proposed removing oral phenylephrine from over the counter (OTC) medications due to “effectiveness concerns.”
According to FDA, oral phenylephrine is widely used as an active ingredient in nasal decongestants. The agency conducted a comprehensive review of all available data on the safety and efficacy of oral phenylephrine including historical and newer clinical data.
“It is the FDA’s role to ensure that drugs are safe and effective. Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER).
Nathan Jones, CEO of Xlear Inc. (American Fork, UT) responded to FDA’s decision, stating, “With the FDA concluding that this common decongestant isn’t effective, as we enter cold and flu season, and as families prepare to celebrate the holidays, many Americans need an answer for the discomfort of sinus congestion.”
Jones further elaborated on how xylitol (the active ingredient in many of Xlear’s products) can help with congestion.
“For congestion caused by pathogens—like colds and flus—people can enhance that effect by using a nasal spray that contains xylitol. A series of studies show xylitol (a natural sugar) deactivates and/or blocks the adhesion of many types of viruses and bacteria to your airway cells,” Jones said. “Adhesion is the process by which a pathogen attaches to your tissue to initiate infection. Using a nasal spray with xylitol helps block adhesion of these pathogens.”
For more information, visit www.xlear.com.
