Ban of ineffective phenylephrine could affect access to other remedies

A study reveals that cold medications containing phenylephrine, a nasal decongestant, might not be effective. Despite this, consumers continue to favor these remedies. Now, the U.S. Food and Drug Administration is considering removing phenylephrine from store shelves after a panel voted unanimously that the drug does not effectively clear stuffy noses. However, this move could disrupt the supply chain, leaving sick consumers without easily accessible over-the-counter options, as reported in the Journal of the American Medical Association.

Phenylephrine is often combined with other effective drugs such as analgesics, cough suppressants, and antihistamines, and marketed as a multi-symptom product under various brand names like Dayquil, Sinex, Mucinex, and Benadryl. The only other approved nasal decongestant, pseudoephedrine, has tighter regulations due to its potential use in making methamphetamine. As a result, phenylephrine products have become more popular among consumers than those containing pseudoephedrine.

Between 2012 and 2021, consumers purchased 19.8 billion units of phenylephrine products compared to 13.2 billion units of pseudoephedrine products. Despite the inefficacy of phenylephrine, the accompanying ingredients in these cold remedies do provide relief for cough and cold symptoms, as noted by Dr. Timothy Anderson, an assistant professor of medicine with the University of Pittsburgh.

If phenylephrine is removed from store shelves, all phenylephrine-containing products would need to be reformulated, potentially impacting the supply chain, according to the researchers. This predicament underscores the need for tighter regulation of over-the-counter medications by the FDA, as suggested by Dr. Anderson, emphasizing the importance of holding over-the-counter drugs to a standard of effectiveness similar to prescription drugs.