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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.
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 FDA advisory committee’s decision last year was nonbinding — meaning the FDA itself makes the final call on whether oral phenylephrine is considered effective and whether it needs to be ...
The OTC drug phenylephrine does not work to relieve congestion, an FDA advisory panel said Tuesday. The ingredient is found in a number of cold and allergy pills. FDA panel says common over-the ...
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.
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." But in their letter, Hendeles and Hatton say phenylephrine does not effectively relieve nasal stuffiness at this dose."
The US Food and Drug Administration announced a proposal to remove oral phenylephrine – a common ingredient in many popular over-the-counter decongestants – from the market, citing evidence ...
The Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. 91–513, 84 Stat. 1236, enacted October 27, 1970, is a United States federal law that, with subsequent modifications, requires the pharmaceutical industry to maintain physical security and strict record keeping for certain types of drugs. [1]