Government advisers say the leading decongestant used by millions of Americans to treat nasal congestion doesn't actually work.
The leading decongestant used by millions of Americans looking for relief from a stuffy nose is no better than a dummy pill, according to government experts who reviewed the latest research on theAdvisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the key drug found in popular versions of Sudafed, Dayquil and other medications stocked on store shelves.
Those original versions of Sudafed and other medicines remain available without a prescription, but they're less popular and 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. The group also told the FDA that studying phenylephrine at higher doses was not an option because it can push blood pressure to potentially dangerous levels.
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 advisers essentially backed the conclusions of an FDA scientific review published ahead of this week's meeting, which found numerous flaws in the 1960s and 1970s studies that supported phenylephrine's original approval. The studies were"extremely small" and used statistical and research techniques no longer accepted by the agency, regulators said.
A trade group representing nonprescription drugmakers, the Consumer Healthcare Products Association, argued that the new studies had limitations and that consumers should continue to have"easy access" to phenylephrine.
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