The call from the Food and Drug Admin on removing the drug, phenylephrine, affects a LOT of cold relief medicines…..
An advisory panel to the Food and Drug Administration agreed unanimously on Tuesday that a common decongestant ingredient used in many over-the-counter cold medicines is ineffective.
The panel’s vote tees up a likely decision by the agency on whether to essentially ban the ingredient, phenylephrine, which would result in pulling hundreds of products containing it from store shelves.
If the F.D.A. ordered their removal, a trade group warned that numerous popular products — including Tylenol, Mucinex and Benadryl cold and flu remedies — might become unavailable as companies race to reformulate them.
Agency officials generally follow the recommendations of the advisory panels, though not always, and it could take some months before a final decision is made. And the findings could be contested, prolonging any move toward product substitutions or removing certain stock at stores…..
For consumers, the potential benefits of ending use of the ingredient, the agency suggested, would include avoiding unnecessary costs or delays in care by “taking a drug that has no benefit.”
Although there is no known health risk associated with taking a combination cold medicine that contains phenylephrine, consumers unable to get relief from a single dose should not take additional doses in a short span of time to feel better. Higher levels of the other ingredients may be dangerous when taken in excess, experts cautioned…..