The over-the-counter decongestant aisle is set to undergo significant changes as the FDA begins phasing out phenylephrine, a key ingredient in many widely-used cold and flu medications.
Found in products like Sudafed and DayQuil, phenylephrine has long been criticized for its ineffectiveness in relieving nasal congestion. After years of scrutiny, the FDA has proposed revoking its use in pills and liquid solutions, signaling a shift that could reshape how Americans manage colds.
Phenylephrine became a staple in cold medicines nearly two decades ago, but recent studies have cast serious doubts on its efficacy. Research indicates that the drug performs no better than a placebo when it comes to clearing nasal passages. The FDA’s decision follows unanimous votes from federal advisers, who reviewed both contemporary and older studies, finding the original data flawed. This move is being hailed as a victory for researchers and academics who have questioned the drug’s utility for years.
For consumers, the removal of phenylephrine from shelves may initially cause confusion but is expected to lead to better options for managing cold symptoms. Doctors argue that eliminating ineffective medications will simplify choices and direct people toward more reliable alternatives. “It’s a win for public health,” said Dr. Brian Schroer of the Cleveland Clinic, who believes the change will ultimately make it easier for Americans to find treatments that work.
Drugmakers are now faced with the challenge of reformulating products or pulling them entirely. Phenylephrine-based oral medications generate nearly $1.8 billion annually, making this a significant shift for the pharmaceutical industry. While phenylephrine is still deemed effective in nasal sprays, these products are far less popular and are unlikely to fill the void left by the pills and liquid formulations.
Consumers are expected to turn to pseudoephedrine, an older and more effective decongestant. However, since pseudoephedrine is regulated and sold behind the pharmacy counter due to its potential misuse in illegal drug production, obtaining it may require additional effort. This could reignite debates about balancing accessibility with safety in drug regulations.
As the FDA implements this decision, doctors and pharmacists are urging people to focus on tried-and-true remedies for nasal congestion. Simple solutions like saline sprays, humidifiers, and pseudoephedrine-based medications are being recommended over flashy, ineffective alternatives. The agency’s move is a reminder of the importance of scrutinizing the evidence behind medical products, particularly those marketed for everyday use.
The coming months will likely see a period of adjustment as drugstores revamp their shelves and consumers adapt to new products. For many, this change represents an opportunity to trust that what they’re buying will genuinely work. By eliminating ineffective options, the FDA hopes to pave the way for a more reliable and evidence-based approach to over-the-counter medications.