FDA advisors say decongestants in cold, allergy medicines are ineffective

  • 2 Min To Read
  • 8 months ago

In a recent advisory panel meeting, a group of experts unanimously declared that the main ingredient in many popular over-the-counter cold and allergy medications, phenylephrine, is ineffective at relieving nasal congestion. This ingredient can be found in drugs like Nyquil, Benadryl, Sudafed, and Mucinex. The Food and Drug Administration (FDA) typically follows the advice of its advisory committees, so there is a possibility that they will begin the process of removing phenylephrine from the market.

If phenylephrine is removed from the market, manufacturers will have to reformulate their cough and cold medications, which could have a significant impact on companies like Procter & Gamble and Johnson & Johnson. These companies generate billions of dollars in sales from drugs containing phenylephrine. However, it's important to note that the FDA is not required to follow the advice of its advisory committees.

The Consumer Healthcare Products Association, a trade organization representing manufacturers and distributors of over-the-counter drugs, has not yet commented on the advisory panel's vote. It remains to be seen how this decision will impact consumers, as they may need to switch to entirely new medications or opt for liquid and spray versions of phenylephrine, which were not included in the FDA review.

This advisory panel meeting was prompted by researchers at the University of Florida, who petitioned the FDA to remove phenylephrine products based on studies showing their lack of effectiveness. Similar concerns were raised in 2007, but the FDA allowed the products to remain on the market pending further research. However, FDA staff, in briefing documents posted ahead of the meeting, concluded that oral formulations of phenylephrine do not work at standard or higher doses, as only a small amount of the drug reaches the nose to relieve congestion.

The FDA's decision on whether to remove phenylephrine from the market will have significant implications for both manufacturers and consumers. It is important to consider the potential impact on individuals who rely on these medications for relief from cold and allergy symptoms.


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