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A Common Cold Medication Ingredient Deemed Worthless by FDA Experts
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A Common Cold Medication Ingredient Deemed Worthless by FDA Experts.
On Sep 12, a panel of 16 advisors to the U.S. Food and Drug Administration (FDA) unanimously voted to determine that a common active ingredient in cold medications, oral phenylephrine, is no more effective in treating nasal congestion than a placebo.
This call by the panel sets the stage for potential actions that the FDA may take, which could lead to the removal of certain over-the-counter drugs containing this ingredient, including some formulations of Mucinex, Sudafed, Tylenol, and NyQuil.
As noted by The New York Times, the panel’s vote does not necessarily guarantee that the FDA will take action, but the agency typically follows the recommendations of expert panels. However, the FDA may opt to delay action for several months, awaiting the outcome of manufacturer disputes and other considerations.
Several older studies that suggested the effectiveness of the drug were rejected by the expert panel due to issues such as data integrity, small sample sizes, and methodological concerns.
The latest research data, considered more in line with modern clinical trial standards by the expert panel, showed that at recommended doses, phenylephrine had “no significant difference” from a placebo. This included trials from 2007 that were reviewed by the FDA after a citizen’s petition.
The panel cited the drug’s low bioavailability (the quality of drug absorption by the human body) as a primary reason for its potential removal from the market. While the drug may have an effect at higher doses, most FDA advisors believed this to be unnecessary and even risky for phenylephrine. In a video recording, the panel explained their unanimous vote:
Dr. William Figg of the National Cancer Institute stated that he believed the drug had “very low bioavailability…precluding further study at higher doses.” Dr. Paul Pisarik pointed out potential negative effects of the drug at larger doses, saying, “If we’re taking 60 or 80 milligrams of phenylephrine, then we have to start worrying about elevated blood pressure because at 100 milligrams, blood pressure goes up 10 points.”
Jennifer Schwazott stated that the drug “should have been removed from the market a long time ago,” and Dr. Stephen Clemente added that while the drug itself isn’t dangerous, patients using it should be considered unsafe as it could delay the actual treatment of their illness symptoms.
The panel members unanimously agreed that the presence of phenylephrine in the medication does not automatically negate its efficacy, as other components can still treat cold symptoms. Pseudoephedrine was suggested by the expert panel as an effective alternative, and while it is technically available without a prescription, it requires consultation with a pharmacist to obtain, as the excessive use of pseudoephedrine can be used in the production of methamphetamine.
(source:internet, reference only)