The FDA has initiated the process to remove oral phenylephrine from the list of approved over-the-counter decongestants, following a conclusion that the drug is ineffective in treating nasal congestion. The proposed order came after a review of scientific studies that have consistently shown that phenylephrine offers no significant benefit over a placebo. Although it was approved in the 1970s and has been a popular alternative since pseudoephedrine became restricted, new studies have concluded that the drug is poorly absorbed and largely ineffective when taken orally. This move has sparked dissent from the industry, with the Consumer Healthcare Products Association disputing the FDA's findings and indicating plans to comment on the proposal.

Key Points:

• FDA proposes to remove oral phenylephrine from the OTC monograph due to its ineffectiveness.
• A review of studies shows no significant difference between phenylephrine and placebo.
• Phenylephrine was approved in the 1970s but became more prominent after pseudoephedrine restrictions.
• Subsequent studies indicated poor absorption of phenylephrine when taken orally.
• The Consumer Healthcare Products Association disagrees with the FDA's conclusion and plans to respond.
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