Washington — The U.S. Food and Drug Administration has announced a proposal to remove oral phenylephrine, a common ingredient found in many popular over-the-counter nasal decongestants, from the market, citing evidence that it is ineffective.
Phenylephrine, found in products such as Sudafed PE, Vicks DayQuil, and Mucinex Sinus-Max, has been widely used as a nasal decongestant for decades. FDA’s proposal is not an immediate mandate. There will be a six-month public comment period, after which the agency will make a final decision on whether to remove the book from shelves.
CVS preemptively stopped selling products containing phenylephrine last year after an FDA advisory panel declared phenylephrine ineffective. Other major pharmacies, including Walgreens and Rite Aid, still stock products containing the drug for now.
Phenylephrine was approved for over-the-counter use by the FDA in the 1970s, but in 2005 legislation banned products using the similar nasal decongestant pseudoephedrine (also used in large quantities to make methamphetamine) from drug stores. After being moved behind the counter, its popularity skyrocketed. .
Although there are no concerns about the safety of phenylephrine, its effectiveness has been debated for many years. In 2007, an FDA advisory committee that reviewed available research deemed phenylephrine “possibly effective” as a decongestant, while recommending further research.
Since then, several large clinical trials have shown that the drug is not effective when taken orally. In September 2023, an FDA advisory committee concluded that the evidence is clear that phenylephrine is ineffective at normal oral doses.
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If the FDA ultimately decides to ban the ingredient, it will give manufacturers time to “reformulate or remove drugs containing oral phenylephrine from the market,” said the director of the FDA’s Office of OTC Drugs. One Dr. Teresa Michele said Thursday.
Phenylephrine is also used in nasal sprays to relieve nasal congestion, but Michele noted that the FDA’s proposal only covers oral formulations.
The Consumer Healthcare Products Association, which represents over-the-counter drug manufacturers, said it was disappointed by the FDA’s move.
“CHPA changes the GRASE (Generally Recognized as Safe and Effective) status of oral PE for nasal obstruction removal based on data available since the last review in 2007. …PE is the only oral OTC nasal decongestant available with no purchase restrictions, and is comparable to many OTC cough and cold medications labeled as nasal decongestants. in medicine,” the association said in a statement.
“Consumers need self-care options, and freedom of self-care choice is a core attribute of our nation’s health care system. Because Americans have the right to choose safe and effective over-the-counter medicines, P.E. It should remain an available option for consumers’ tastes and recourse. ”
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