CSPI urges removal of ineffective oral decongestant phenylephrine from market

Drug works as a nasal spray but not as a pill

The nasal decongestant phenylephrine does not work when taken in oral form and should be removed from the marketplace, according to the nonprofit Center for Science in the Public Interest.

Together with Drs. Leslie Hendeles and Randy Hatton, two pharmacists who filed petitions seeking phenylephrine’s removal as early as 2007, CSPI filed comments with the Food and Drug Administration expressing support for the agency’s proposed order to remove oral phenylephrine from Over-the-Counter (OTC) Monograph M012, which sets out which cold, cough, and allergy medications are safe and effective.

This submission follows growing scientific evidence and a unanimous vote by the FDA Nonprescription Drug Advisory Committee in 2023 that oral phenylephrine is not effective as a nasal decongestant.

Oral phenylephrine is widely marketed in cold and flu medicines, including Sudafed PE, DayQuil Cold & Flu, and Mucinex Cold, Flu & Sore Throat. According to the FDA, Americans spent $1.76 billion on 242 million packages of oral products containing phenylephrine in 2022. Despite the ubiquity of oral phenylephrine products, decades of clinical and pharmacological evidence have shown that phenylephrine does not improve nasal congestion compared to a placebo when taken orally. Nonetheless, these products remain on store shelves, costing consumers billions of dollars in ineffective treatment and potentially delaying treatment with non-prescription drugs that actually are effective.

Phenylephrine first came under intense scrutiny after access to pseudoephedrine, another decongestant, was placed behind the pharmacy counter by statute in 2005 due to its potential use in illicit methamphetamine synthesis. Manufacturers subsequently reformulated many decongestants to contain oral phenylephrine—despite existing doubts about its efficacy.

Drs. Hendeles and Hatton began challenging oral phenylephrine’s efficacy in a 2007 citizen petition, suggesting that the FDA’s approved 10 milligram dose was not supported by evidence. They called for the removal of phenylephrine from the OTC monograph in a 2015 citizen petition, when new studies demonstrating ineffectiveness became available and submitted further supporting data in 2022.

In September 2023, the FDA’s advisory committee reviewed original and updated efficacy data and concluded unanimously that oral phenylephrine at current doses is not effective. Notably, FDA’s briefing materials made clear that the original studies reviewed by the 1976 OTC Monograph Panel had methodological and statistical limitations.

Large, well-designed studies conducted more recently found no significant differences between oral phenylephrine and placebo in relieving nasal congestion. Briefing materials established that less than 1 percent of oral phenylephrine gets into the blood stream, explaining the lack of efficacy. Based on this review and recommendation, the FDA issued a proposed order to remove oral phenylephrine from OTC products, determining that it is no longer generally recognized as safe and effective.

“Safe and very effective alternatives are currently available without a prescription,” said Dr. Hendeles, PharmD, Professor Emeritus in the College of Pharmacy and Department of Pediatrics at the University of Florida. “For nasal stuffiness from a cold, a phenylephrine nasal spray is available as well as the longer acting oxymetazoline spray that gives almost instant relief, and several topical nasal corticosteroid sprays or an antihistamine spray are available for stuffiness caused by allergies.”

"The current lack of an effective oral decongestant in front of the counter is no excuse to sell an ineffective one anywhere in the store,” said CSPI executive director Dr. Peter G. Lurie. “Removing oral phenylephrine will not inhibit access to actual congestion relief but will help consumers avoid spending money on medications that do not work.”

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