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On Thursday, the FDA proposed removing oral phenylephrine from the list of approved active ingredients for over-the-counter (OTC) nasal decongestants, citing concerns over its effectiveness. After ...
The unanimous vote, which specifically declared oral formulations of phenylephrine ineffective, is expected to disrupt the market for OTC cold and allergy remedies, where consumers largely prefer ...
The U.S. Food and Drug Administration (FDA) announced that it plans to ban products containing phenylephrine, an ingredient found in many over-the-counter (OTC) oral cold and flu medications.
The stakes are high, experts say, because a committee vote declaring phenylephrine ineffective as an oral decongestant could push the FDA to revoke the drug’s over-the-counter designation as ...
[13] [2] Phenylephrine has replaced pseudoephedrine in many over-the-counter oral decongestant products. [2] However, oral phenylephrine appears to be ineffective as a decongestant. [ 31 ] [ 32 ] In 2022, the combination with brompheniramine and dextromethorphan was the 265th most commonly prescribed medication in the United States, with more ...
The FDA notes the proposed order is not based on safety concerns, and that the presence of oral phenylephrine in these medicines does not affect how other active ingredients treat symptoms.
Actually, J&J came up with phenylephrine in the 70s, but nobody has bothered to use it until pseudoephedrine became restricted. From the link "In 1976, the FDA deemed a 10 milligram oral dose of phenylephrine safe and effective at relieving congestion, making it possible for companies to use the ingredient without conducting studies."
[1] [10] If treatment of the lesions is ineffective, studies have shown that intravenous fentanyl, a slow-acting narcotic, or a fentanyl patch can be used to slow respiration. In patch form, fentanyl is a good alternative to morphine therapy for its high lipid solubility and ability to be worn on the body.