Changes are on the horizon for over-the-counter cold and cough medications as U.S. regulators move to eliminate phenylephrine, a common decongestant found in many popular remedies. The Food and Drug Administration (FDA) has determined that this ingredient, featured in brands like Sudafed and DayQuil, does not effectively relieve nasal congestion.
The FDA’s recent proposal to revoke phenylephrine’s approval for use in pills and liquid medications marks the start of a process that could lead to its removal from store shelves. This decision is based on growing evidence that the drug is no better than a placebo when taken orally, leaving consumers searching for alternative treatments.
Phenylephrine, often combined with other ingredients to treat colds, flu, and allergies, has been under scrutiny for years. While it remains widely available, many medical professionals have doubted its efficacy. “People walk into pharmacies, see rows of medications, and pick something that ultimately won’t work,” said Dr. Brian Schroer of the Cleveland Clinic.
Last year, an FDA advisory panel reviewed several large, recent studies comparing phenylephrine’s effectiveness to a placebo and found no significant difference in relieving nasal congestion. The panel also reexamined older studies from the 1960s and 1970s that initially supported the drug’s use and identified flaws and unreliable data in those findings.
Importantly, the FDA’s proposal targets phenylephrine in oral medications, which generate around $1.8 billion in annual sales in the U.S. The drug is still considered effective when used in nasal sprays, though these products are far less popular than pills and syrups.
For consumers, the upcoming changes may lead to a shift in how they manage congestion and colds.
Alternatives for nasal congestion
As phenylephrine begins to fade from store shelves, individuals seeking relief will need to explore other options. One alternative is pseudoephedrine, another decongestant found in products like Sudafed and Claritin-D. Unlike phenylephrine, pseudoephedrine is stored behind pharmacy counters due to the potential for misuse in the production of illegal substances. However, it remains available without a prescription.
Other effective methods for clearing nasal passages include saline rinses and drops, which help flush out mucus and provide quick relief. For longer-term management of seasonal congestion and related symptoms, nasal steroid sprays are often recommended by healthcare providers. These sprays, used daily, are particularly effective for controlling inflammation and congestion over time.
“Steroid nasal sprays are the most effective option for relieving nasal congestion,” said Dr. Schroer. “The challenge is that their daily use can be inconvenient for some patients.”
For short-term relief, antihistamine sprays like Astepro can provide faster results, especially for congestion caused by allergies.
Phenylephrine’s phase-out process
Although the FDA has proposed removing phenylephrine from its list of approved over-the-counter decongestants, the process will take time. The agency must follow a multi-step procedure, which includes a six-month public comment period. During this time, consumers, healthcare professionals, and pharmaceutical companies can provide feedback on the proposal.
After reviewing these comments, the FDA will issue a final decision. Even if the ruling goes against phenylephrine, manufacturers will likely have at least a year or more to reformulate their products or remove them from the market entirely.
Drugmakers may also opt to challenge the decision, potentially delaying the timeline further by requesting additional hearings or presenting new evidence.
The Consumer Healthcare Products Association, a trade group representing pharmaceutical companies, has pushed back against the FDA’s proposal, arguing that consumers should retain the ability to choose products containing phenylephrine. The group stated that Americans “deserve access to the products they prefer for managing their health.”
A shift in consumer choices
While the FDA’s decision-making process continues, phenylephrine-containing products will remain available on store shelves. However, consumers may start to rethink their choices as awareness of the drug’s ineffectiveness grows.
For many, this transition represents an opportunity to explore treatments that provide real relief. Whether it’s pseudoephedrine, steroid sprays, antihistamines, or simple saline solutions, there are alternatives that can effectively address nasal congestion and other cold symptoms.
The FDA’s actions underscore a broader effort to ensure over-the-counter medications meet high standards of efficacy. While phenylephrine has long been a staple in cold and flu remedies, its removal may ultimately lead to better options for consumers seeking reliable relief.
As the process unfolds, the landscape of over-the-counter cold and cough medications will likely change, but the goal remains clear: to provide Americans with treatments that work, backed by sound scientific evidence.
