FDA Advisory Panel Rules that Oral Phenylephrine Is Ineffective

Jennifer Middleton, MD, MPH
Posted on September 25, 2023

A recent U.S. Food and Drug Administration (FDA) advisory panel has concluded that over-the-counter (OTC) oral phenylephrine is ineffective as a nasal decongestant. This finding is not especially surprising, as oral phenylephrine’s effectiveness has been questioned for decades. The FDA, though, must now decide whether to require phenylephrine’s removal from OTC cough and cold products, which may "significantly disrupt the market for the makers of cold medicines” and confound our patients looking for relief from common cold symptoms as the U.S. heads into fall and winter.

The Combat Methamphetamine Act of 2005 moved pseudoephedrine, which is quite effective for the temporary relief of nasal congestion, behind the counter of U.S. pharmacies. Pseudoephedrine was being used to produce illicit methamphetamines, and the U.S. Drug Enforcement Agency (DEA) wanted to limit its access. This restriction on pseudoephedrine, however, has not decreased the use of illicit methamphetamines in the U.S.. Pseudoephedrine is available in most of the U.S. without a prescription, though a few states require a prescription. It is now stored behind pharmacy counters, and purchasers must show a U.S. driver’s license or identification card. Understandably concerned about the effect of this change on sales, OTC cold and cough medication manufacturers quickly reformulated their products with phenylephrine instead (for example, “Sudafed” went behind the counter but “Sudafed PE” sits on drugstore shelves). Unfortunately, purchasers of these phenylephrine products likely did not experience any improvement in their nasal congestion; “‘[i]f you have a stuffy nose and you take this medicine, you will still have a stuffy nose.’”

Phenylephrine may be ineffective but it’s not dangerous in OTC doses, and patients with common cold symptoms may still find some relief from the other ingredients in multi-product formulations. It should be noted that nasal phenylephrine was not included in this review and is effective for nasal congestion. We can help our patients navigate viral upper respiratory tract infections (URIs) by reminding adult patients that “[t]reatments with proven effectiveness...include over-the-counter analgesics, zinc, nasal decongestants with or without antihistamines, and ipratropium for cough”. The list of safe and effective treatment options in children with URIs includes "acetylcysteine, honey (for children one year and older), nasal saline irrigation, intranasal ipratropium, and topical application of ointment containing camphor, menthol, and eucalyptus oils,” and we should remind parents and caregivers that children under the age of 4 years should not use any OTC cold products. Vaccinations for influenza, COVID, and RSV reduce morbidity and mortality, and handwashing remains the best prevention for all of these viral illnesses.

You can find more information about the FDA advisory committee’s review of phenylephrine effectiveness data here. The DEA website has information on dextromethorphan, another OTC cough/cold medication with abuse potential. And, AFP has plenty of resources for you as we head into the colder months in the Northern hemisphere: the AFP By Topic on Respiratory Tract Infections includes resources for physicians and patients on the common cold and RSV, and there are also AFP By Topics on Influenza and COVID-19.