F.D.A. Panel Finds Common Cold Medicine Ingredient Ineffective

An advisory panel to the Food and Drug Administration (F.D.A.) has unanimously deemed phenylephrine, a frequent ingredient in over-the-counter cold medicines, as ineffective in treating nasal congestion. This decision may push the F.D.A. to potentially ban products containing this ingredient.

With a potential ban looming, there could be a renewed focus on pseudoephedrine, another decongestant. However, its sales have restrictions due to its use in illegal meth labs, making its purchase cumbersome.

Dr. Leslie Hendeles, who first petitioned the F.D.A. in 2007 to consider the inefficacy of phenylephrine, stated, “The bottom line is quality research has told the true story about phenylephrine.” However, the Consumer Healthcare Products Association defended the ingredient, emphasizing its safety and efficacy. They warned of the broader implications of its ban, suggesting it might overwhelm the U.S. health care system.

While the F.D.A. is yet to make a final decision, it’s evident that the agency leans toward the panel’s recommendation. Future actions could include potential lawsuits and lobbying attempts by corporations impacted by any F.D.A. ruling.

Phenylephrine Snapshot:

  • Usage: Phenylephrine is commonly used as a decongestant in over-the-counter cold and flu medicines.
  • D.A. Panel’s Verdict: An advisory panel to the F.D.A. unanimously found phenylephrine ineffective for treating nasal congestion.
  • Sales Impact: Products containing phenylephrine accounted for nearly $1.8 billion in sales last year.
  • Popular Brands: Phenylephrine can be found in brands such as Sudafed, NyQuil, Tylenol, Mucinex, and Benadryl.
  • Safety Status: Despite questions about its efficacy, phenylephrine has long been considered safe by the F.D.A.
  • Other Uses: Apart from oral medications, phenylephrine is deemed effective in nasal sprays, and it’s also used in surgeries and to dilate the eyes.
  • Alternatives: Pseudoephedrine is another oral decongestant. However, its sales are restricted because of its use in illicit meth labs.
  • Debate History: Dr. Leslie Hendeles first petitioned the F.D.A. in 2007 to review the efficacy of phenylephrine, emphasizing that high-quality research had questioned its effectiveness.
  • Consumer Impact: While phenylephrine is not dangerous, it’s believed to not offer relief from nasal congestion when taken orally.
  • Industry Reaction: The Consumer Healthcare Products Association asserts that phenylephrine is both safe and effective. They warn of potential negative consequences if the ingredient is banned.

About the Author

F.D.A. Panel Finds Common Cold Medicine Ingredient Ineffective

Editor Prism MarketView