Government advisers say the leading decongestant used by millions of Americans to treat nasal congestion doesn't actually work.
WASHINGTON — 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.
The FDA assembled its outside advisers to take another look at phenylephrine, which became the main drug in over-the-counter decongestants when medicines with an older ingredient — pseudoephedrine — were moved behind pharmacy counters. A 2006 law had forced the move because pseudoephedrine can be illegally processed into methamphetamine.
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 FDA review begun in the 1972. 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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