FDA proposes removal of active ingredient from oral nasal decongestants after efficacy concerns

The U.S. Food and Drug Administration proposed the removal of oral phenylephrine as an active ingredient from over-the-counter monograph drug products designed to treat nasal congestion.

The decision came after the agency conducted a comprehensive review of available safety and efficacy data and concluded that oral phenylephrine may not be an effective active ingredient as a nasal decongestant.

The proposed removal of phenylephrine will only affect the orally administered forms of the drug and not nasal sprays. The FDA emphasized that the findings were based on efficacy, not safety concerns.

Read more: FDA

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