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☆ US FDA panel says popular decongestant used in cold medicines ineffective
▼ + stars: | 2023-09-12 | by ( ) www.reuters.com time to read: +1 min

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo Acquire Licensing RightsSept 12 (Reuters) - An outside panel of experts to the U.S. Food and Drug Administration on Tuesday refused to back the effectiveness of oral over-the-counter (OTC) medicines made with phenylephrine, an ingredient widely used in cold and cough syrups. The panel unanimously voted against the effectiveness of orally administered phenylephrine as a nasal decongestant, adding that no more trials were required to prove otherwise. The FDA usually follows the recommendations of its expert panel but is not obligated to do so. Phenylephrine was substituted for pseudoephedrine in many non-prescription cold and allergy medicines after the latter was restricted amid reports of abuse.

Persons: Andrew Kelly, Jennifer Schwartzott, Phenylephrine, Mariam Sunny, Devika Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug Administration, GSK, Thomson Locations: White Oak , Maryland, U.S, United States, Bengaluru

☆ Your cold pills could be yanked off the shelf. An FDA panel just ruled some of them don't work.
▼ + stars: | 2023-09-12 | by ( Associated Press | Haley Tenore | ) www.businessinsider.com time to read: +6 min

A Food and Drug Administration panel said phenylephrine, a commonly used decongestant, doesn't work. Phenylephrine is found in dozens of over-the-counter cold medications to relieve sinus congestion. Phenylephrine versions — sometimes labeled "PE" on the packaging — make up the rest. Several other commonly purchased cold and congestion relief medications also contain phenylephrine, according to The Wall Street Journal. This time, the 16 members of the FDA panel unanimously agreed that current evidence doesn't show a benefit for the drug.

Persons: Phenylephrine, Allegra, Dayquil, Mark Dykewicz, Johnson, Jennifer Schwartzott, drugmakers Organizations: Drug Administration, Food and Drug Administration, Saint Louis University School of Medicine, FDA, Bayer, Wall Street, Allergy, University of Florida, Consumer Healthcare Products Association, Congress

The advisers also told the FDA that studying phenylephrine at higher doses was not an option because it can push blood pressure to dangerous levels. This time, the 16 members of the FDA panel unanimously agreed that current evidence doesn't show a benefit for the drug. Additionally, three larger, rigorously conducted studies published since 2016 showed no difference between phenylephrine medications and placebos for relieving congestion. Those studies were conducted by Merck and Johnson & Johnson and enrolled hundreds of patients. Like many other over-the-counter ingredients, phenylephrine was essentially grandfathered into use during a sweeping FDA review begun in the 1972.

Persons: Allegra, Dayquil, ”, Mark Dykewicz, Johnson, Paul Pisaric, “, Jennifer Schwartzott, Peter Starke, drugmakers, Theresa Michele Organizations: WASHINGTON, Food and Drug Administration, Saint Louis University School of Medicine, FDA, Bayer, Archwell Health, University of Florida, Merck, Johnson, Consumer Healthcare Products Association, Congress, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP Locations: Oklahoma

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