Kids with allergies at risk of developing more of them, study confirms

In 2007, the FDA committee looked at the science available at that time and came to a different conclusion, agreeing that the phenylephrine “may be effective,” but it also called for more research.īoy sneezes due to allergies Kontrec/E+/Getty Images/FILE The agency approved phenylephrine for over-the-counter use in the 1970s, but it became even more common after 2005, when legislation restricted access to OTC drugs that use a similar decongestant ingredient called pseudoephedrine. But if the FDA agrees with the committee, companies may be required to remove products with phenylephrine from store shelves or reformulate them. During that process, companies would still be allowed to market products with phenylephrine. If the agency decides to reclassify phenylephrine from Generally Recognized as Safe and Effective (GRASE), stakeholders would have the opportunity to comment on the proposed change and to provide any additional data. The FDA told the committee it would take its advice into consideration, although it did not give a timeline.

Diane Ginsburg of the University of Texas at Austin College of Pharmacy. “We really should not have products on the market that are not effective,” said committee member Dr. The vote was unanimous among its 16 members, and the committee agreed that the issue doesn’t need to be studied any further. On Tuesday, the committee voted no on the specific question: “Do the current scientific data that were presented support that the monograph dosage of orally administered phenylephrine is effective as a nasal decongestant.” These products generated nearly $1.8 billion in sales last year alone, according to data from the FDA that was presented to the Nonprescription Drugs Advisory Committee on Monday during the committee’s two-day meeting. But many doctors have questioned phenylephrine’s effectiveness for years.

The ingredient is considered safe to use that was not up for debate. Tim Boyle/Getty Images/FileįDA committee to consider whether ingredient in many popular decongestants actually works In this 2006 photo, Sudafed PE nasal decongestant is displayed on a shelf at a Walgreens store in Chicago, Illinois.

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