Popular over-the-counter decongestant doesn’t work: FDA

A popular over-the-counter nasal decongestant found in common cold and allergy medications doesn’t actually relieve congestion, a Food and Drug Administration panel found.

The group of FDA experts voted Tuesday against the effectiveness of phenylephrine, which is found in products like Sudafed, Benadryl, Allegra and Dayquil, finding it was no more effective than a placebo.

If the wider agency follows the panel’s recommendations, drug makers like Johnson & Johnson and Bayer may be required to remove oral medications containing phenylephrine from stores.

The panel also advised against increasing the dosage of phenylephrine in these medications since it can raise blood pressure to dangerous levels.

Phenylephrine became the chief ingredient in over-the-counter medications and replaced pseudoephedrine after the Combat Methamphetamine Epidemic Act of 2005 was passed in 2006. Pseudoephedrine can be used in the manufacturing and processing of crystal meth.

Researchers from the University of Florida petitioned the FDA to convene on the issue when numerous studies found orally-ingested phenylephrine products fared no better than placebo pills for patients experiencing congestion. A panel met in 2007 and made a similar recommendation but the FDA decided against pulling the powerless products since the experts’ suggestions are not binding.

Since 2016, three large-scale studies conducted by Merck and Johnson & Johnson have reached similar conclusions.

However, multiple studies have found phenylephrine administered through drops or sprays to the nose to be effective against nasal decongestion.

The FDA has not updated its list of approved decongestants since 1995.

With News Wire Services