Government advisers say the leading decongestant used by millions of Americans to treat nasal congestion doesn't actually work.
Those original versions of Sudafed and other medicines remain available without a prescription, but they account for about one-fifth of the $2.2 billion market for oral decongestants. Phenylephrine versions — sometimes labeled “PE” on packaging — make up the rest.
That was also the recommendation of FDA’s outside experts at the time, who met for a similar meeting on the drug in 2007. “The bottom line is that none of the original studies stand up to modern standards of study design or conduct,” said Dr. Peter Starke, the agency’s lead medical reviewer. Like many other over-the-counter ingredients, phenylephrine was essentially grandfathered into use during a sweeping. It has been sold in various forms for more than 75 years, predating the agency’s own regulations on drug effectiveness.
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