William Fig, a clinical pharmacologist and investigator at the National Cancer Institute.Įvery year, many Americans seek relief with over-the-counter cold and allergy medicine. “It’s amazing the amount of dollars being spent on something that has really no efficacy,” said committee member Dr. Rather, they were advising the FDA to act because the tablets were essentially a waste of money, and over-the-counter medications can help people who have colds or allergies. In discussing Tuesday’s vote, the committee agreed that safety wasn’t why they wanted the FDA to take action on these products. How to choose the right air purifier for you A citizen petition is a way for industry, consumer groups or individuals to petition the FDA to change regulations or take other administrative action. In pill form, some scientists say, phenylephrine gets absorbed by the gut and is metabolized so well that only a tiny bit makes it to the bloodstream, where it is needed to reach the nose, according to the citizen petition that asks the FDA to pull the drug from store shelves. Decongestants constrict the blood vessels in the sinuses and nose, reducing the swelling and helping fluids drain. A respiratory infection or allergies prompt the body to send white blood cells to the nose, throat and sinuses, leading to swelling in the nasal membranes and the creation of mucus. Phenylephrine works by temporarily reducing the swelling of blood vessels in the nasal passages. Last year, the group supported a citizens petition to remove the drug’s over-the-counter status. Phenylephrine is considered the most common ingredient in over-the-counter oral nasal and sinus products, according to the American Academy of Allergy, Asthma and Immunology. The committee did not take up the issue of nasal spray products that use phenylephrine, which studies seem to show are effective, at least temporarily. The FDA found that those study results were inconsistent and many did not meet modern scientific standards. The committee also looked at other research used to support its use over-the-counter. Studies since then, including three large clinical trials, showed that the orally administered ingredient is not effective as a decongestant in its typical dosage. 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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