7 Mar 2023 • The U.S. Food and Drug Administration has asked a panel of its advisors to reassess the effectiveness of the oral version of phenylephrine. The medication’s safety isn’t in question, just whether it actually does what it claims to do.

The FDA initially received a new petition to withdraw the medication back in 2015, submitted by University of Florida pharmacy professors Leslie Hendeles and Randy Hatton. The duo had cited new data that showed phenylephrine was not more effective than a placebo. "Let me be clear, oral phenylephrine is not a safety risk," Hatton told CBS News. "It just doesn't work."

"When you take it orally, it goes to the gut. And as it's being absorbed through the gut, there are two enzymes that metabolize it to such a great extent that essentially a very miniscule amount makes it into the bloodstream," Hatton explained.

The FDA’s Nonprescription Drugs Advisory Committee will meet in April to consider the effectiveness of the oral version of phenylephrine.

Source: US News | Read full story