A Food and Drug Administration advisory panel declared on Tuesday that a common oral decongestant, phenylephrine, is not effective in relieving a stuffy nose, leaving many consumers and pharmaceutical companies with questions heading into the cold and flu season.
Phenylephrine became more widely used as an oral decongestant in the early 2000s, when the Drug Enforcement Agency began more closely to regulate the more effective drug pseudoephedrine due to its use as an ingredient in methamphetamine.Researchers, however, began reevaluating the efficacy of phenylephrine shortly thereafter, with results of a 2007 study demonstrating its insufficient efficacy compared to placebos.
Here is everything you need to know about the decongestant market to be prepared for the coming flu and fall allergy season.Both phenylephrine and pseudoephedrine work by restricting blood vessels in the nasal passageways, making it easier to breathe. Because of their effects on blood vessels, both drugs have the side effects of raising blood pressure and should be avoided by those with cardiovascular problems.
"Why is oral phenylephrine so useless? It is extensively metabolized, starting in the gut wall," explained organic chemist Derek Lowe in a 2022 article published in Science. Lowe said that the useful rate of absorption"increases at higher doses as you apparently saturate out some of the metabolic pathways, but at the 10mg dose typically used for decongestants, you can forget it.
In many states, pseudoephedrine is also available in limited quantities without a prescription at pharmacy counters. The Combat Methamphetamine Epidemic Act of 2005, incorporated into the PATRIOT Act, requires the patient to present a photo ID for purchase, and pharmacies must keep this information for at least two years after purchase.
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