Nasal decongestant phenylephrine has been used in versions of Sudafed, Benadryl, NyQuil and other popular products, but it has been found to be ineffective when taken orally.
Nearly 20 billion units of phenylephrine were sold between 2012 and 2021, but last year FDA advisors determined the nasal decongestant is ineffective and the agency is considering recalls for Sudafed, Tylenol and other drugs
Several years ago, the makers of Tylenol settled hundreds of lawsuits over liver damage caused by acetaminophen overdose, and the FDA is now reminding users about the serious health risks.
Nasal decongestant lawsuits began to be filed throughout the federal court system this year, after an FDA advisory committee determined the ingredient phenylephrine is not effective when taken orally.
Researchers say it would be a "disservice" to consumers if the FDA leaves the ineffective nasal decongestant on the market, indicating widespread cold medication recalls are necessary
Even though the nasal decongestant did not work, the pharmaceutical industry raked in nearly $2 billion selling cold medications containing phenylephrine last year, according to a recent class action lawsuit.
FDA advisors say a decongestant commonly used in OTC cold medications has low bioavailability, making it ineffective when taken orally. The findings may result in a wave of decongestant recalls in the coming months.
