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While the FDA has issued a proposal, it has yet to issue a final order, which would determine the future availability of products containing oral phenylephrine as a nasal decongestant.
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 ...
In September 2023, an FDA advisory committee of 16 experts held a two-day meeting, which culminated with the announcement that oral phenylephrine is not effective, and works no better than a ...
Phenylephrine was originally approved by the FDA in 1976 based on reports that suggested the medication helped reduce congestion. Worth noting: The overwhelming “ evidence ” to support this ...
Phenylephrine, which alongside paracetamol is one of Lemsip's two primary active ingredients and is intended to be responsible for most of the product's claimed effects, was discovered to be ineffective as a decongestant in 2015, leading some pharmacists to call for the ingredient to be banned. [4]
The Food and Drug Administration (FDA) is proposing the removal from the market of a common ingredient found in most oral over-the-counter cold medicines because it doesn’t work.
Phenylephrine, sold under the brand names Neosynephrine and Sudafed PE among others, is a medication used as a decongestant for uncomplicated nasal congestion in the form of a nasal spray or oral tablet, [5] to dilate the pupil, to increase blood pressure given intravenously in cases of low blood pressure, and to relieve hemorrhoids as a suppository.
Phenylephrine is an oral medication primarily used as a decongestant. [5] [6] It is a selective α 1-adrenergic receptor activator which results in the constriction of both arteries and veins. [5] Common side effects include nausea, headache, and anxiety. [5] Phenylephrine was patented in 1927 and came into medical use in 1938. [7]