An independent advisory panel of the FDA votes against phenylephrine use as a decongestant

Experts from the U.S. Food and Drug Administration (FDA) have disclosed that common over-the-counter decongestants with Phenylephrine do not work. Following a review of the latest research on the drug ingredient, members of an FDA Advisory panel confirmed that it doesn’t provide relief or any improvement for congestion. 

Phenylephrine, an active ingredient found in many over-the-counter decongestants including Sudafed, Benadryl, and Robitussin, had initially been approved to replace pseudoephedrine. This was another decongestant that was taken off drugstore shelves in 2006 due to the presence of an illegal stimulant called methamphetamine.

Phenylephrine drugs will soon disappear

With the emergence of recent studies which found that Phenylephrine is, in fact, not more effective than a placebo against allergies, experts have now voted unanimously against the effectiveness of the drug ingredient, claiming inconsistencies in past studies. 

“In conclusion, we do believe that the original studies were methodologically unsound and do not match today’s standard. By contrast, we believe the new data are credible and do not provide evidence that oral phenylephrine is effective as a nasal decongestant,” said Dr. Peter Starke, an FDA official who led the review panel.

While it might take a while before any regulation is made, these new findings could now see common phenylephrine drugs taken off the shelves of medical stores. 

Another FDA warning

This news comes on the same day the FDA sent warning letters to eight companies for allegedly marketing illegal eye drug products which were not FDA approved. The agency, in a news release, announced this as part of its efforts to protect people from harmful eye products. 

The illegal products were found to mainly be in use for treating conditions such as conjunctivitis, glaucoma, cataracts, and dry eye. The FDA warned that these products when applied directly to the eyes could take down some of the body’s natural defences, hence making them potentially harmful. 

Additionally, the agency mentioned that some of these drug products contain silver, which has been found to be associated with agyria, a condition that permanently causes some areas of skin to turn bluish-grey after long-term use. 

The warning letters were sent to Boiron Inc., CVS Health, DR Vitamin Solutions, Natural Ophthalmics, Inc., OcluMed LLC, Similasan AG/Similasan USA, TRP Company, Inc., and Walgreens Boots Alliance, Inc.. 

The FDA also threatened to take legal action against the companies if they fail to reply within 15 days of receiving the letter.

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