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FDA Advisory Panel Finds Decongestant Ingredients Ineffective

Today’s video is brief and our comments will be fairly brief because we expect more to follow on this topic. A recent video championed the Food and Drug Administration (FDA) for not approving the drug thalidomide. Forty-six other countries approved the drug which was later shown to cause miscarriages and deformities in infants whose mothers had taken the drug.

Today’s video doesn’t champion the FDA since the public recently learned that an FDA Advisory Panel deemed a common ingredient, phenylephrine, which is apparently in Tylenol, Mucinex, Sudafed PE, Benadryl, and perhaps many other over-the-counter medications, ineffective. Worse, there have been efforts within the medical community to bring this issue to light for many years. Worse still, it appears likely that there are many other over-the-counter medications with ineffective ingredients on the market.

I taped today’s video in September and later that month, on September 29, an interesting article appeared in the New York Times written by Drs. Randy Hutton and Leslie Hendreles, We’ve Known for 20 Years This Cold Medicine Doesn’t Work. These doctors are pharmaceutical experts with the University of Florida who worked to encourage the FDA to force removal of phenylephrine from popular over-the-counter medications.

In October, CVS announced it would no longer sell over-the-counter medications with phenylephrine. That makes sense. At the same time, it is amazing to learn that throughout most of our lives we’ve all been buying over-the-counter medications that don’t provide the relief they are supposed to at the doses included in the medications. The manufacturers of these drugs should be proactive in ensuring that products they sell are both safe and effective. The articles I’ve seen assure us that phenylephrine does no harm. Nevertheless, it is disappointing that so many products with this ingredient have been sold over so many years, enriching the companies that likely knew the truth about phenylephrine, while the FDA seemed to sit idly by while it happened.

There is much more to follow on this topic because the FDA generally accepts the recommendations of its Advisory Panel but hasn’t yet ruled on phenylephrine.