The Food and Drug Administration (FDA) is looking to remove oral phenylephrine from its list of approved over-the-counter ingredients. After a committee review, the oral decongestant was unanimously determined to be ineffective, according to FDA. However, removal from store shelves would occur no earlier than 2026, and the agency emphasizes that its proposed ban is based on effectiveness concerns, not on safety concerns. Over-the-counter oral phenylephrine has been on the market for 30 years.
Chime in now: The FDA is seeking comments on this proposed order on a public website. It does not appear that the agency would put phenylephrine behind the counter as it has with pseudoephedrine-containing decongestant products that had the potential for misuse and safety concerns. Urgent care clinicians, due to the prevalence of upper respiratory presentations, routinely recommend over-the-counter medications and might soon find fewer choices.