The US Food and Drug Administration (FDA) has proposed the removal of oral phenylephrine as a decongestant, citing its ineffectiveness in relieving nasal congestion. Three large studies conducted by Merck and Johnson & Johnson found no significant difference between phenylephrine and a placebo, leading to the FDA’s reevaluation of the drug.
The FDA Proposes Removal of Oral Phenylephrine as a Decongestant
The US Food and Drug Administration (FDA) has taken the first steps towards removing oral phenylephrine from over-the-counter decongestants, citing its ineffectiveness in relieving nasal congestion.
Background on Phenylephrine
Phenylephrine was originally approved by the FDA in 1976. However, researchers had questioned the efficacy of phenylephrine in treating nasal congestion. The drug gained popularity after pseudoephedrine, a main component of Sudafed, was moved behind pharmacy counters to prevent its use in making methamphetamine.
Studies Show Ineffectiveness
Three large, carefully designed studies conducted by Merck and Johnson & Johnson found no significant difference between phenylephrine and a placebo in relieving nasal congestion. The FDA reevaluated the drug again last year, taking into consideration these new studies and a deeper look at 14 studies from the 1950s to 1970s that initially earned phenylephrine its approval.
The FDA Noted Methodological Flaws
The FDA noted that those 14 studies used a dubious measure of nasal airway resistance that has since been abandoned. Even with this shoddy measurement, the studies provided mixed efficacy results, and the overall finding of efficacy hinged on only two studies conducted at the same lab.
Industry Group Disputes Move
Despite the seemingly damning evidence, the Consumer Healthcare Products Association (CHPA), an industry group representing makers of phenylephrine-containing products, disputed the FDA’s move. CHPA maintains its position on the drug’s efficacy and will review the proposed order before submitting comments accordingly.
Next Steps
The FDA will open up a public comment period, and if no comments can sway the agency’s previous conclusion that the drug is useless, the FDA will make the order final. Drugmakers will get a grace period to reformulate their products.
This move marks a long-sought change in the FDA’s stance on oral phenylephrine, with many experts and researchers calling for its removal from over-the-counter decongestants due to its ineffectiveness.
