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Pulling “Ineffective” Decongestant From Shelves Could Disrupt Supply Chain

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In 2023, a US Food and Drug Administration (FDA) advisory panel concluded there was no evidence that a common over-the-counter decongestant – oral phenylephrine – was effective.

Now, a new study has found that, despite this conclusion, phenylephrine remains popular among consumers, and pulling it from the shelves could create supply chain disruptions.

Effective or not?

Phenylephrine is a decongestant, used to relieve a stuffy nose during a bout of cold or flu. It is available over the counter (OTC) in oral pills or as a nasal spray.

However, there have been suggestions over the last several decades that oral phenylephrine may not be as effective as we once thought.

This led to an advisory panel to the FDA in 2023 concluding that there is no scientific data to support the efficacy of oral phenylephrine formulations as a nasal decongestant.

Currently, medications like phenylephrine are sold OTC as they are generally recognized as safe and effective (GRASE) by the FDA. However, this conclusion means the FDA can issue a proposed order to remove phenylephrine from sale OTC.

The FDA stated in a press release that, if no longer considered GRASE, it would “work closely with manufacturers to reformulate products as needed to help ensure availability of safe and effective products to treat symptoms of colds or allergies.”

Researchers from the University of Pittsburgh analyzed sales of phenylephrine and another OTC decongestant, pseudoephedrine, in response to the FDA’s call for public comment on whether to remove phenylephrine from sale. The research is published in JAMA.

Phenylephrine remains a popular choice

They found that phenylephrine was the most common oral decongestant in the study period (2012–2021). During this time, US pharmacies purchased 19.8 billion units of phenylephrine products versus 13.2 billion units of pseudoephedrine products.

However, there are also differences in how the two decongestants are formulated. Pseudoephedrine is typically sold as a standalone product, whereas phenylephrine is commonly combined with other drugs – such as acetaminophen or antihistamines – to treat multiple symptoms experienced during a cold, for example.

Therefore, pulling phenylephrine from sale could also remove these multi-symptom products, potentially leading to supply chain disruption.

“During the time required for reformulation and introduction of new products, clinicians and consumers could consider oral pseudoephedrine or intranasal decongestants, including phenylephrine or oxymetazoline, as alternatives,” the authors wrote in the paper.

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"The FDA needs to hold [OTC] drugs to a standard of effectiveness similar to that of prescription drugs,” said the study’s lead author Dr. Timothy Anderson, an assistant professor of medicine at the University of Pittsburgh. “A comparable pathway is needed for drugs that are sold [OTC] as exists for post-approval monitoring of the risks and efficacy of prescription drugs. This will require a substantial investment in infrastructure to expand capacity.”

Importantly, the FDA’s recommendation relates only to oral phenylephrine formulations; there is still evidence that phenylephrine nasal sprays are effective. However, these are only recommended for short-term use due to their potential to cause rebound congestion.

Reference: Anderson TS, Suda KJ, Gellad WF, Tadrous M. Trends in phenylephrine and pseudoephedrine sales in the US. JAMA. 2024. doi: 10.1001/jama.2023.27932