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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 ...
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 ...
An advisory committee to the FDA agreed this week that oral decongestant medications with phenylephrine are ineffective. Here is what we know about what does work. An FDA advisory group confirmed ...
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 ...
Such a ban was discussed as a result of multiple cases of alcohol poisoning and alcohol-related blackouts among users of such drinks. The majority of these alcohol poisoning cases were found on college campuses throughout the United States. Caffeinated alcoholic drinks such as Four Loko, Joose, Sparks and Tilt were the most popular around the U.S.