FDA Must Prioritize Removal of Oral Phenylephrine From Shelves
Washington, D.C. — In a unanimous vote Tuesday, the 16-member Food and Drug Administration’s (FDA) Nonprescription Drugs Advisory Committee agreed that the current (monograph) dosage of orally administered phenylephrine is not effective for relief of nasal congestion.
The committee’s decision was based on thorough and consistent analyses presented by the agency’s scientists showing that this drug, which is present in numerous over-the-counter medicines such as DayQuil, Sudafed PE and Tylenol Cold + Flu Severe, does not work.
In testimony earlier this week, Public Citizen’s Health Research Group urged the advisory committee to vote against the efficacy of this oral drug for nasal congestion at the current dosage or other possibly safe higher dosage. Based on updated technological methods, the FDA’s clinical pharmacologists have confirmed that the bioavailability of phenylephrine, when taken orally, is less than 1% because the drug is broken down during absorption. In addition, the FDA’s medical reviewer showed that publicly available data from three modern adequately controlled, industry-sponsored clinical trials illustrate the lack of efficacy of oral phenylephrine at current or reasonably higher doses.
Azza AbuDagga, Ph.D., a health services researcher for Public Citizen’s Health Research Group, released the following statement in response:
“We applaud the FDA for its work compiling and presenting evidence against the efficacy of orally administered phenylephrine. That this placebo-like, decades’ old drug remains on pharmacy shelves is a disservice to the millions of Americans who bought this drug in 2022 alone and many others who will likely purchase it in the coming weeks and months.
“We now urge the FDA to prioritize prompt removal of all oral phenylephrine-containing products from the U.S. market — a process that must include a robust education campaign about the inefficacy of these products and the availability of several effective treatment alternatives, including nasal phenylephrine.”