The Food and Drug Administration (FDA) has announced a proposal to remove oral phenylephrine from the list of approved over-the-counter (OTC) drugs for treating nasal congestion, citing evidence that the oral form of the medication is ineffective. This decision comes after an FDA advisory committee concluded in September 2023 that the drug does not provide relief from nasal congestion when taken orally.
The proposal is open for public comment until May 7, 2025, after which the FDA will make its final decision. Until then, companies can continue to manufacture and market oral phenylephrine products, as the proposal is based on the drug's effectiveness, not safety.
Scope of the Proposed Ban
The FDA's proposal specifically targets orally administered phenylephrine found in tablets and capsules. Nasal spray formulations of phenylephrine are not affected by this proposal. According to Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, the decision aligns with the FDA's role to ensure drugs are both safe and effective.
Phenylephrine's Rise to Prominence
Phenylephrine's widespread use in OTC cold medications began in 2006 following the Combat Methamphetamine Epidemic Act. This law restricted over-the-counter sales of pseudoephedrine, a more effective decongestant, due to its use in methamphetamine production. Drug companies then switched to phenylephrine, which the FDA had previously deemed safe and effective in the 1970s.
Evidence of Ineffectiveness
However, subsequent research, including a 2007 paper by Leslie Hendeles, PharmD, professor emeritus at the University of Florida College of Pharmacy, indicated that oral phenylephrine was no more effective than a placebo in treating nasal congestion. Later studies with stronger designs and larger sample sizes reinforced these findings, leading to the FDA advisory committee's conclusion in 2023.
Alternative Treatments
Experts recommend several alternative treatments for nasal congestion. For common colds, nasal sprays containing phenylephrine can be effective, as the drug is absorbed directly into the nasal passages. Oral pseudoephedrine, available behind the pharmacy counter for adults 18 and older, remains a viable option. For allergies, nasal steroids like Flonase and antihistamine nasal sprays like Astepro are recommended.
Sterling Elliott, PharmD, a clinical pharmacist and assistant professor of orthopedic surgery at Northwestern University Feinberg School of Medicine, advises caution against overuse of nasal decongestant sprays, as daily use for more than a week can lead to congestion rebound.
