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The US Food and Drug Administration announced Proposal To remove oral phenylephrine – a common ingredient in many popular pharmacies – from the market, citing. Evidence That it doesn't work.
Phenylephrine, found in products such as Sudafed PE, Vicks DayQuil, and Mucinex Sinus-Max, has been widely used for nasal congestion for decades. The FDA proposal is not an immediate order; It begins a six-month public comment period, after which the agency makes a final decision to pull it from the shelves.
In pre-emptive action, C.V.S He stopped selling products with phenylephrine after an FDA advisory committee declared it ineffective last year. Other major pharmacies, including Walgreens and Rite Aid, still stock products containing the drug.
Although phenylephrine received FDA approval for over-the-counter use in the 1970s, its popularity skyrocketed in 2005 following the outlawing of a similar decongestant, pseudoephedrine — which, in large quantities, can also be used to make methamphetamine — behind pharmacy counters. .
The safety of phenylephrine is not a concern, but its effectiveness has been debated for years. In the year In 2007, an FDA advisory panel recommended more research but reviewed existing studies suggesting that phenylephrine may be “potentially effective.”
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.
If the FDA ultimately decides to ban the substance, it will allow manufacturers “time to reformulate or remove drug products containing oral phenylephrine from the market,” Dr. Theresa Michel, director of the FDA's Office of Nonprescription Drugs, said Thursday.
Phenylephrine is also used in nasal sprays to relieve congestion, but Michel pointed out that the FDA's proposal only targets oral dosage forms.
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The Consumer Healthcare Products Association, which represents manufacturers of over-the-counter drugs, said it was disappointed by the FDA's move.
“CHPA maintains its position that there are no changes to GRASE. [generally recognized as safe and effective] Oral PE is warranted for nasal congestion based on data from the last review in 2007. … PE is the only oral OTC decongestant available without a prescription and is included in many OTC cough and cold medications that are labeled as such. The association he said. In the description.
“Consumers want options for self-care, and freedom of choice for self-care is a core feature of our nation's health care system. PE must remain an available option for consumers, because Americans deserve the choice of safe and effective OTC medications of their choice.