Phenylephrine: The FDA wants to pull the popular decongestant from shelves over concerns about its effectiveness

CNN
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The U.S. 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 that it doesn’t work.

Phenylephrine, found in products like Sudafed PE, Vicks DayQuil, and Mucinex Sinus-Max, has been widely used as a nasal decongestant for decades. The FDA’s proposal is not an immediate order; A six-month public comment period will begin, after which the agency will make a final decision on whether to remove it from the shelves.

As a preventative measure, CVS stopped selling products containing phenylephrine last year after an FDA advisory committee said it was ineffective. Other major pharmacies, including Walgreens and Rite Aid, still carry products containing the drug for now.

Although phenylephrine was approved by the FDA for over-the-counter use in the 1970s, its popularity skyrocketed in 2005 after legislation banned products that use a similar decongestant, pseudoephedrine – which is also used in large quantities to make methamphetamine can be – banished behind the pharmacy counter.

Phenylephrine’s safety is not a cause for concern, but its effectiveness has been debated for years. In 2007, an FDA advisory panel that reviewed available studies concluded that phenylephrine “may be effective” as a decongestant but recommended further research.

Since then, several large clinical trials have shown that the drug is ineffective when taken orally. In September 2023, an FDA advisory committee concluded that the evidence was clear that phenylephrine was ineffective at its typical oral dosage.

If the FDA ultimately decides to ban the ingredient, it will give manufacturers time to “either reformulate or withdraw drugs containing oral phenylephrine from the market,” Dr. Theresa Michele, director of the FDA’s Office of Non-Prescription Drugs, on Thursday.

Phenylephrine is also used in nasal sprays to relieve congestion, but Michele noted that the FDA’s proposal only targets oral forms of the drug.

The Consumer Healthcare Products Association, which represents manufacturers of over-the-counter medications, said it was disappointed by the FDA’s action.

“CHPA maintains its position that there are no changes to GRASE [generally recognized as safe and effective] The status of oral PN for nasal congestion is justified based on data available since the previous review in 2007. … PE is the only OTC oral decongestant available without purchase restrictions and is included in numerous OTC cough and cold medications labeled “decongestant,” the association said in a statement.

“Consumers need options for self-care, and choice in self-care is a core feature of our nation’s healthcare system. PE should remain an available option for consumers because Americans deserve the opportunity to choose the safe and effective OTC medications they prefer and rely on.”