WASHINGTON — Significant changes are on the horizon for over-the-counter cold and cough medications. The U.S. Food and Drug Administration (FDA) has made the decision to phase out phenylephrine, a commonly used decongestant in popular medications like Sudafed and Dayquil, after concluding that it is ineffective at relieving nasal congestion.
Phenylephrine has long been a staple in medications designed to alleviate the discomfort associated with colds, flu, and allergies. However, multiple studies and expert opinions have questioned its efficacy. In December 2024, the FDA proposed to revoke its approval for use in oral pills and liquid solutions, a decision based on the conclusion that phenylephrine does not provide the relief it promises. The FDA’s action follows a unanimous vote by an advisory panel in 2024, which found no evidence that oral phenylephrine products work better than a placebo in reducing congestion.
The FDA’s decision is a response to long-standing concerns raised by researchers, including those at the University of Florida, who have petitioned the FDA to reconsider the use of phenylephrine since 2007. The evidence suggests that when ingested, phenylephrine is rapidly broken down in the digestive system, rendering it ineffective before it can reach the nasal passages.
As the FDA moves toward removing phenylephrine from the market, consumers may need to look for alternative decongestants. One option is pseudoephedrine, which was previously the most common decongestant in cold medicines. Due to concerns about its potential misuse in the production of methamphetamine, pseudoephedrine is now sold behind the pharmacy counter, and consumers are required to show identification to purchase it. Products containing pseudoephedrine, such as Sudafed and Claritin D, remain effective and available with this restriction.
For those seeking over-the-counter remedies, nasal sprays or solutions, including saline sprays, remain a viable option. Nasal steroids, such as Flonase, Nasacort, and Rhinocort, are also recommended by doctors for long-term relief of nasal congestion and related symptoms. These medications are effective when used consistently but may not provide immediate relief.
While phenylephrine-based nasal sprays will still be available, the discontinuation of phenylephrine in oral medications will prompt consumers to reconsider their choices. Experts agree that the FDA’s decision will ultimately benefit public health, helping consumers make more informed choices about the medications they use. According to Dr. Brian Schroer of the Cleveland Clinic, removing ineffective options from the market will make it easier for individuals to select products that truly provide relief for their symptoms.
For more information about effective alternatives to phenylephrine, consider visiting resources like the Mayo Clinic or the American Academy of Allergy, Asthma, and Immunology.
The decision to remove phenylephrine from the market will not be immediate. The FDA must still review public comments on its proposal and will then issue a final order. The process may take up to two years, but once finalized, the change will mark a significant shift in the cold and cough medicine landscape.
