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☆ Decongestant found in many cold, allergy medicines doesn’t actually work, FDA advisors say
▼ + stars: | 2023-09-12 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

The main ingredient used in many popular over-the-counter cold and allergy medications doesn't actually work to get rid of nasal congestion, an advisory panel to the Food and Drug Administration declared Tuesday. The FDA typically follows the advice of its advisory committees but it is not required to do so. Pulling phenylephrine from the market could also affect retail pharmacy chains, which rake in revenue from selling over-the-counter cold and allergy pills. Retail stores in the U.S. sold 242 million bottles of drugs containing phenylephrine last year, up 30% from 2021, according to data compiled by FDA staff. Yet FDA staff, in briefing documents posted ahead of the meeting this week, concluded that oral formulations of phenylephrine don't work at standard or even higher doses.

Persons: Johnson, Scott Melville Organizations: Food and Drug Administration, FDA, Procter, Gamble, Consumer Healthcare Products Association, CVS, Walgreens, University of Florida Locations: U.S

☆ A Decongestant in Cold Medicines Doesn’t Work at All, an F.D.A. Panel Says
▼ + stars: | 2023-09-12 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +3 min

Every cold and flu season, millions of Americans reach for these products, some over decades. The decongestant is in at least 250 products that were worth nearly $1.8 billion in sales last year, according to an agency presentation. Among the products: Sudafed Sinus Congestion, Tylenol Cold & Flu Severe, NyQuil Severe Cold & Flu, Theraflu Severe Cold Relief, Mucinex Sinus Max and others. The ingredient has long been considered safe and effective under an old, outdated agency standard, and the F.D.A. The agency also may give the drug companies a grace period to swap ingredients in products, if required.

Persons: Leslie Hendeles, Hendeles, ”, Marcia D, Howard Organizations: Staples, Medicine Cabinet, University of Florida, Consumer Healthcare Products Association, White

☆ 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

☆ Medication manufacturers operating 24/7 to fix supply shortages, says CHPA's Scott Melville
▼ + stars: | 2022-12-23 | by ( ) www.cnbc.com time to read: 1 min

Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailMedication manufacturers operating 24/7 to fix supply shortages, says CHPA's Scott MelvilleConsumer Healthcare Products Association CEO Scott Melville joins CNBC's 'Squawk Box' to discuss what's causing a shortage of children's medication and when parents can expect supplies to normalize.

☆ High demand for children's medications shines a light on fragile US drug supplies
▼ + stars: | 2022-12-12 | by ( Brenda Goodman | ) edition.cnn.com time to read: +13 min

Even when demand is not sky-high, drugs shortages happen regularly – but usually more quietly – in the US. At any time, the reasons why shelves may be empty vary from place to place and from drug to drug. With children’s medications, drug manufacturers say they are running full-tilt, and they planned for some increase in sales over the winter months. The FDA tracks drug shortages too, taking reports directly from manufacturers, but it defines them differently than the pharmacists’ group. The White House says drug shortages are a priority for President Biden’s administration, too.

☆ How the $36 billion vitamin industry tricked a generation of adults into believing sugary gummies were the ticket to good health
▼ + stars: | 2020-10-07 | by ( Rachel Premack | ) www.businessinsider.com time to read: +21 min

But some consumer advocates and doctors worry that those supplements don't have as many benefits as people think. "Our gummy vitamins have been on fire," CEO Matt Farrell told investors in a July earnings call. He said that Hero Nutritionals, founded in 1995, created the first gummy vitamin for the American market. A Perrigo representative said it no longer manufactured gummy vitamins, and it did not respond to further inquiries.) But the doctor had something to admit: He takes a gummy vitamin every day.

Persons: Robert Shmerling's, who's, they're, It's, Shmerling, Chuck Bell, Charlene Elliot, Zers, sassily, you'll, Gummy, Kim Kardashian's Instagram, Matt Farrell, Andrew Stablein, it's, Hollis Johnson, Ingrid Sorensen, Sorensen, Libby Mindarino, Mindarino, Peter Waitzman, I'm, John Troup, Troup, Nutritionals, Jennifer Hodges, Hero, America's, Hodges, Bernd Settnik, Lil, gummies, Perrigo, Olly, SmartyPants, Dwight, University of Calgary's Elliot, Millennials, Gen Zers, Elliot, Lunchables, Courtney Nichols Gould, Kim Kardashian, Kylie Jenner, @sugarbearhair, Kylie 🤍, ike, alo, ike J ames Organizations: Harvard Medical School, Consumer, University of Calgary, Brands, Netflix, Big Tech, Walmart, Target, Business, Nutrition Business, . Church, Consumers, Bayer, Companies, New York Times, pharma, Consumer Healthcare Products Association, Sweet, Getty, Centers for Disease Control, Perrigo, Church, University of Calgary's Locations: Boston, America, gummy, Atlanta, Ireland, Dwight, Patagonia, osh

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