Government advisers say the leading decongestant used by millions of Americans to treat nasal congestion doesn't actually work.
FILE - Sudafed and other common nasal decongestants containing pseudoephedrine are on display behind the counter at Hospital Discount Pharmacy in Edmond, Okla., Jan. 11, 2005. The leading decongestant used by millions of Americans looking for relief from a stuffy nose is likely no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient. Advisers to the Food and Drug Administration voted unanimously on Tuesday, Sept.
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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