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FDA Proposes Removing Ineffective Oral Phenylephrine from OTC Cold Medicines Including Sudafed and Benadryl

Nov 7, 2024, 08:15 PM

The U.S. Food and Drug Administration (FDA) proposed on Thursday to remove oral phenylephrine, a widely used active ingredient in over-the-counter cold and cough medications, including brands such as Sudafed and Benadryl, stating that it is not effective as a nasal decongestant. The proposal aligns with the advice of the FDA's advisory committee and follows new research indicating that phenylephrine is ineffective when taken orally in pill or syrup form. The FDA emphasized that there are no safety concerns associated with the drugs but aims to ensure that medications on the market are both safe and effective. "It is FDA’s role to ensure that drugs are safe and effective," said an FDA official. "Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step to propose removing oral phenylephrine because it is not effective as a nasal decongestant." This move brings the FDA one step closer to removing products containing oral phenylephrine from pharmacy shelves.