Advisers 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.
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 backed the conclusions of an FDA scientific review published before this week’s meeting, which found numerous flaws in the 1960s and 1970s studies that supported phenylephrine’s original approval. Regulators said the studies were “extremely small” and used statistical and research techniques no longer accepted by the agency.
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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