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☆ CVS to pull certain cold medicines containing decongestant phenylephrine from store shelves
▼ + stars: | 2023-10-19 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

CVS is removing some of the most common cough and cold medicines from its store shelves and will no longer sell them, a company spokesperson told CNBC on Thursday. However, CVS is voluntarily removing certain cough and cold medicines that contain phenylephrine as the only active ingredient from stores. They added that CVS stores will continue to offer other oral cough and cold products to meet patient needs. Oral products that list phenylephrine as its only active ingredient include Sudafed PE, which is marketed by Johnson & Johnson's consumer health spinoff Kenvue . Pulling oral phenylephrine from the market entirely could affect CVS and other retail pharmacy chains, which rake in revenue from selling over-the-counter cold and allergy pills.

Persons: Johnson, Kenvue Organizations: CNBC, Food and Drug Administration, FDA, CVS, Street Journal Locations: U.S

☆ Why the F.D.A. Took So Long to Tackle a Disputed Cold Remedy
▼ + stars: | 2023-09-15 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +1 min

Dr. Leslie Hendeles began prodding the Food and Drug Administration to reject a decongestant in cold medicines when he had a mop of curly red hair and Bill Clinton had just become president. By the time opposition to the drug had coalesced, Dr. Hendeles was appearing, at age 80, as an expert to testify before the agency’s advisers, his hair white and his overview of the ingredient spanning 50 years. His advocacy culminated in the advisory panel’s unanimous vote on Tuesday, when it concluded that the decongestant, a common ingredient in cold and flu remedies, is ineffective. Prompted by the news, consumers threw open their medicine cabinets upon learning that the decongestant, phenylephrine, was listed in more than 250 of their go-to drugs for congestion like some versions of DayQuil, Sudafed, Tylenol and Theraflu. And the decision has caused some confusion — experts say the ingredient still works in nasal sprays, just not when taken orally in pill or liquid form.

Persons: Leslie Hendeles, Bill Clinton, Hendeles Organizations: and Drug Administration

☆ FDA Advisory Committee: Ingredient in common decongestant ineffective
▼ + stars: | 2023-09-14 | 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 EmailFDA Advisory Committee: Ingredient in common decongestant ineffectiveDr. Scott Gottlieb joins 'Power Lunch' to discuss cold medicine being found to be ineffective in decongestant and the latest push from the government for Americans to get vaccinated against Covid-19.

Persons: Scott Gottlieb Organizations: FDA, Covid Locations: decongestant

☆ Insider Today: Apple's new iPhone is here
▼ + stars: | 2023-09-13 | by ( Dan Defrancesco | ) www.businessinsider.com time to read: +9 min

This post originally appeared in the Insider Today newsletter. But the show's real stars were the new versions of Apple's iPhone and Apple Watch. But if you were hoping a new iPhone will send Apple's stock soaring, think again. Prior to Tuesday's event, Apple's shares fell an average of 0.2% on days a new iPhone was announced, according to Barron's. The Insider Today team: Dan DeFrancesco, senior editor and anchor, in New York City.

Persons: Bond, Elon Musk's, Justin Sullivan, Octavia Spencer, Tim Cook, Max, Insider's Sarah Jackson, Jordan Hart, Lakshmi, iPhones, Gary Coronado, Jamie Dimon, — Warren Buffett —, Bill Gross, DoubleLine's Jeffrey Gundlach, Pimco, DoubleLine's, Gross, Anna Moneymaker, Thomas Trutschel, isn't, Sundar Pichai, Elon, Walter Isaacson, Read, Kent Walker, Chelsea Jia Feng, Patreon, Naomi Osaka, Shaquille O'Neal, Allegra, Dayquil, Jennifer Aniston, Reese Witherspoon, Yelp, Dan DeFrancesco, Naga Siu, Hallam Bullock, Lisa Ryan Organizations: Service, Jets, Apple, Apple Watch, Getty, Bloomberg, JPMorgan, Wall, Google, Software, Amazon, FDA, North American, Detroit Auto, GMC, Bourbon Locations: Wall, Silicon, Milwaukee, Lakshmi Varanasi, ., China, that's, Latvia, Estonia, Chelsea, Colorado, Arizona, Morocco, New York City, San Diego, London, New York

☆ 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

☆ A Decongestant in Many Cold Medicines Is Ineffective
▼ + stars: | 2023-09-12 | by ( Dani Blum | More About Dani Blum | ) www.nytimes.com time to read: +2 min

Pseudoephedrine, which is found in behind-the-counter products like Sudafed, is effective at clearing congestion, Dr. Dykewicz said; just keep in mind that it can come with side effects. After that, you run the risk of rebound congestion: when the mucosal surfaces in your nose swell, making you feel even more clogged up than before. There are some sprays that you can use for longer stretches, without the rebound risk, namely steroid sprays that contain ingredients like fluticasone (Flonase) or triamcinolone (Nasacort), which are available over-the-counter. Can I treat congestion without medication? In many cases, you can treat a stuffed-up nose by standing in a steamy shower or using a humidifier to help clear your nasal passages, Dr.

Persons: ”, Jennifer Le, Dykewicz, Allegra, Mark Aronica, Le, Andrew Lane, Johns Organizations: Skaggs School of Pharmacy, Pharmaceutical Sciences, University of California, Cleveland Clinic, Sinus Locations: San Diego

☆ 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

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

☆ 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

☆ 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

Feb 15 (Reuters) - Emergent BioSolutions Inc's (EBS.N) over-the-counter version of opioid overdose reversing drug received unanimous support from U.S. Food and Drug Administration's panel of advisers, sending shares of the contract drugmaker up nearly 16% after market. The vote puts the naloxone-based treatment Narcan on track to potentially become the first opioid overdose drug to be sold OTC nationwide. Naloxone rapidly reverses or blocks the effects of an overdose, restoring normal respiration. However, most panelists emphasized that OTC use of the nasal spray was safe and proposed ways to improve its labeling, to avoid using the drug wrong. Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020.

☆ FDA advisors recommend over-the-counter use of life-saving opioid overdose treatment Narcan
▼ + stars: | 2023-02-15 | by ( Spencer Kimball | ) www.cnbc.com time to read: +7 min

Narcan nasal spray quickly reverses an overdose from heroin and prescription painkillers. The Food and Drug Administration's independent advisors on Wednesday unanimously recommended over-the-counter use of the nasal spray Narcan to reverse opioid overdoses, which would significantly expand access to the life-saving treatment. Emergent BioSolutions ' Narcan is the most commonly sold treatment for opioid overdoses. Emergent BioSolutions said Narcan would be available for the over-the-counter market by late summer if the FDA approves it next month. Opioid overdose deaths spiked 17% during the pandemic from about 69,000 in 2020 to nearly 81,000 in 2021.

☆ EMA's safety committee starts review of cold medicines
▼ + stars: | 2023-02-10 | by ( ) www.reuters.com time to read: 1 min

Feb 10 (Reuters) - A European Medicines Agency (EMA) committee said on Friday it has started a review of decongestant medicines for cold and flu that contain the ingredient pseudoephedrine following safety concerns. The EMA said the review was due to reports of conditions affecting blood vessels in the brain in some patients who took pseudoephedrine-containing medicines. Pseudoephedrine is a drug that is used alone or in combination with other medicines to treat a blocked nose due to cold, flu or allergy. Makers of pseudoephedrine-containing drugs include Reckitt Benckiser (RKT.L), McNeil Products Ltd and Organon & Co (OGN.N). Reporting by Sriparna Roy in Bengaluru; Editing by Shounak DasguptaOur Standards: The Thomson Reuters Trust Principles.

That doesn’t mean you’re doomed to wake up in a daze because you’re prone to mouth breathing when you sleep. “Even if you don’t have sleep apnea, or you have mild sleep apnea, opening your mouth makes it much, much worse.”How do you know if you’re mouth breathing at night? How to stop mouth breathingWhen Nestor blocked his nose for science, he experienced an extreme version of mouth breathing. If you’re tackling your nighttime mouth breathing, Park suggested you start by taking care of your nose to minimize congestion. But even if you get your nose to clear, nighttime mouth breathing can be a hard habit to break.

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