The Food and Drug Administration (FDA) has proposed an order to remove oral phenylephrine from all cold, cough, allergy, bronchodilator, and anti-asthmatic drug products available in the United States. This proposal aims to reshape the formulations of many popular over-the-counter medications, such as Sudafed, Mucinex, Benadryl, Advil, Tylenol, Vicks, and Dimetapp. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER), stated, “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”
The FDA’s decision follows a conclusion by an independent advisory body that, while oral phenylephrine is safe to consume, it is ineffective at clearing a stuffy nose.
The advisory panel reviewed evidence from several clinical trials that indicated most phenylephrine ingested orally is broken down in the gut, making it useless as a decongestant. Phenylephrine was approved by the FDA as a safe and effective decongestant in 1976. However, studies supporting its efficacy have since been criticized for poor methodology.
Before 2006, pseudoephedrine was the primary ingredient in over-the-counter decongestants. Due to its use in the illegal manufacture of methamphetamine, federal law restricted its sale, prompting manufacturers to replace it with phenylephrine.
Fda proposes removal of oral phenylephrine
Evidence has mounted questioning the efficacy of phenylephrine over the years. Various petitions and studies have pushed the FDA to reassess its stance. In response to this growing body of evidence, the agency has finally proposed removing oral phenylephrine products from the market.
This proposed order does not affect nasal sprays or eye drops containing phenylephrine, as these delivery methods have been found to be more effective than oral tablets. Many consumers remain unaware of the differences between these forms. If finalized, this ruling will require companies to withdraw products that contain phenylephrine as the sole active ingredient.
This will significantly impact the market, as in 2022, products containing phenylephrine far outsold those containing pseudoephedrine. The public can currently provide feedback on the FDA’s proposal, and further action from the agency is anticipated soon.
