FDA Proposes Removing Ineffective Cold Medicine Phenylephrine from Market
The Food and Drug Administration has proposed removing oral phenylephrine, a common ingredient in over-the-counter cough and cold medicines, from the market due to its ineffectiveness as a nasal decongestant. This decision follows the agency’s own scientific review, which found that oral phenylephrine is poorly absorbed into the bloodstream and its effectiveness is questionable, contradicting earlier studies. The FDA is seeking public comment on this proposal, and if finalized, manufacturers will need to remove or reformulate products containing oral phenylephrine. While the FDA considers oral phenylephrine safe at current levels, it acknowledges that higher doses would be needed to achieve any meaningful effect, raising safety concerns.
John Q. Hosedrinker