ST. LOUIS – It’s a common decongestant ingredient found in hundreds of over-the-counter medications. But now, the FDA’s Nonprescription Drugs Advisory Committee says phenylephrine doesn’t actually get rid of nasal congestion.
“The biggest thing I want people to know is do not panic,” said Dr. Kalyan Katakam, SSM Health Cardinal Glennon Children’s Hospital. “The medicines are safe, whether they’re in your cabinet or on the counter; they’re all safe.”
Katakam has been following the FDA news since Monday. Cold and allergy medications that contain the drug phenylephrine can be found everywhere.
Popular names like Sudafed PE, Benadryl, Vicks Sinex Severe, and NyQuil just to name a few, contain the popular decongestant.
“All they’re saying is the medicine is not absorbed into the body as previously thought, and therefore it’s not as effective, or it’s no more effective as the placebo,” Katakam said.
The FDA advisory panel released results from studies conducted over two decades that show phenylephrine is no more effective than a placebo when taken in pill form.
Up next, the FDA will have to decide whether to revoke the OTC designation as safe and effective.
“There will be that point when the manufacturers will have to take this medication off of these formulations and potentially add alternative formulations,” Katakam said.
Katakam said nasal sprays that contain phenylephrine are considered more effective.
