The Food and Drug Administration (FDA) is taking steps to remove oral phenylephrine from the list of approved over-the-counter (OTC) decongestants, a decision that could significantly change the contents of cold and cough medicine aisles across the United States. This move comes after mounting evidence suggests that oral phenylephrine, a primary ingredient in popular medications like Sudafed PE and Dayquil, is no more effective than a placebo in relieving nasal congestion.
The FDA's decision follows a unanimous vote by federal advisors who reviewed multiple studies, including some dating back to the 1960s and 1970s. These reviews indicated that phenylephrine, when taken orally, is largely ineffective because it is broken down in the gut before it can reach the bloodstream and nasal passages. "This is a good drug, but not when it’s swallowed," said Leslie Hendeles, professor emeritus at the University of Florida’s College of Pharmacy.
The Rise and Fall of Phenylephrine
Phenylephrine's prominence in OTC decongestants grew after the 2006 Combat Methamphetamine Epidemic Act, which restricted access to pseudoephedrine due to its potential use in methamphetamine production. Companies reformulated many products with phenylephrine to keep them readily available on store shelves. However, while pseudoephedrine remained available behind pharmacy counters, the effectiveness of its replacement, phenylephrine, has now been called into question.
Alternatives for Consumers
With the anticipated removal of oral phenylephrine, consumers seeking relief from nasal congestion will need to explore alternative options. Pseudoephedrine-containing products like Sudafed, Claritin-D, and others remain available behind the counter, requiring photo identification for purchase. Other alternatives include saline nasal sprays and rinses, nasal steroids (such as Flonase, Nasacort, and Rhinocort) for long-term relief, and antihistamine sprays like Astepro for short-term relief.
Implications and Next Steps
The FDA's proposal will undergo a period of public comment, allowing consumers and companies to provide feedback. Following this, the FDA will review the comments and issue a final order. Drug manufacturers will then likely have a year or more to remove or reformulate their products. The Consumer Healthcare Products Association has expressed the desire to keep phenylephrine products available, stating that Americans deserve "the option to choose the products they prefer for self-care."
However, researchers like Randy Hatton, a University of Florida professor, disagree, stating, "Our position is that choosing from something that doesn’t work isn’t really a choice."
