FDA says phenylephrine in cold medicine doesn't work

In the United States, the Food and Drug Administration (FDA) has proposed the removal of phenylephrine from over-the-counter cold and flu medicines, citing its ineffectiveness when taken in pill or syrup form. This announcement aligns with a growing concern over the efficacy of various medications approved decades ago, as many rely on outdated scientific standards. Randy Hatton, a professor at the University of Florida College of Pharmacy, explains that while phenylephrine is considered safe, it is poorly absorbed when taken orally, which leads to its lack of effectiveness. Consumers have used this ingredient for years, largely due to its presence in many popular cold remedies without questioning its actual benefits. Hatton underscores that medications must meet both safety and effectiveness criteria to gain FDA approval. He mentions that phenylephrine remains effective in nasal spray form, which may contribute to ongoing confusion among consumers regarding its various formulations. He also points out that patients have alternatives such as pseudoephedrine, which is effective but requires being requested behind the pharmacy counter. The FDA's assessment highlights a troubling trend of potentially ineffective pharmaceutical products continuing in the market, making it crucial for further evaluation of older drugs still widely available to the public. As the winter season approaches, demand for cold medications rises, and many citizens are still purchasing products containing phenylephrine unaware of the recent revelations about its inefficacy. The conversation initiated by the FDA's position raises questions about the responsibility of pharmaceutical companies to ensure their products are both safe and effective. Hatton suggests that more robust scientific scrutiny is necessary to evaluate older medications to prevent consumers from wasting money on ineffective treatments. The FDA's move to re-evaluate substances like phenylephrine not only serves to protect consumers but also emphasizes the importance of incorporating current science into drug effectiveness assessments. For pharmacists and healthcare providers, this scrutiny could reshape recommendations provided to patients seeking cold relief during peak seasons. The ongoing examination of existing medications could lead to changes in over-the-counter options available to the public, ultimately influencing purchasing decisions amid the winter cold and flu season.