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☆ If Some Cold Medicines Don’t Work, What Should You Take for a Stuffy Nose?
▼ + stars: | 2023-10-30 | by ( Jared S. Hopkins | ) www.wsj.com time to read: 1 min

When a cold or flu strikes, choosing among hundreds of products can be overwhelming. But to clear up a stuffy nose, doctors and pharmacists say consumers should choose medicine wisely. A key ingredient found in many over-the-counter medicines—oral phenylephrine—just doesn’t work, according to a finding last month by advisers to the Food and Drug Administration. A few weeks after that determination, CVS Health stopped selling certain oral medicines with the ingredient.

Organizations: Food and Drug Administration, CVS Health

☆ CVS Pulls Certain Cold Medicines From Shelves and Will Stop Selling Them
▼ + stars: | 2023-10-19 | by ( Jared S. Hopkins | ) www.wsj.com time to read: 1 min

CVS operates more than 9,000 retail locations and 1,100 walk-in clinics nationwide. Photo: Ted Shaffrey/Associated PressCVS Health is pulling some of the most common decongestants from its shelves and will no longer sell them, after advisers to U.S. health regulators recently determined that an ingredient doesn’t work. The products contain oral phenylephrine, an almost-century-old ingredient in versions of decongestants and over-the-counter pills, syrups and liquids to clear up congested noses.

Persons: Ted Shaffrey Organizations: CVS, Press CVS Health

☆ 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

☆ An FDA advisory group confirmed some popular decongestants are ineffective. Now what do we do?
▼ + stars: | 2023-09-15 | by ( Madeline Holcombe | ) edition.cnn.com time to read: +6 min

It is safe to use, but an independent advisory committee to the FDA agreed Tuesday that it is ineffective in pill form. But before then, there are things you can do at home to help relieve your symptoms, he said. Warm compresses, hot showers and hydrationNoses like to be hydrated and warm, Brodner said. But steam from a hot shower or a warm compress placed over your nose can also heat things up nicely. That runny nose will help drain mucus from your sinuses — and hopefully flush out whatever is irritating it, Brodner said.

Persons: ”, David C, “ You’ll, ” Phenylephrine, Brodner, guaifenesin, Richard J, Harvey, Shanna Miko, you’re, ” Brodner, Stephen Rennard, Larson, Rennard, “ Organizations: CNN, Food and Drug Administration, FDA, Macquarie University, Epidemic Intelligence, US Centers for Disease Control, CDC, Medicine, University of Nebraska Medical Center Locations: Boynton Beach , Florida, Omaha

☆ 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

☆ 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

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

☆ 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

☆ 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

☆ 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

☆ Why Many Cold Medicines Don’t Work to Relieve Congestion
▼ + stars: | 2022-12-22 | by ( Jared S. Hopkins | ) www.wsj.com time to read: 1 min

Dozens of over-the-counter pills, syrups and liquids rely on an ingredient called phenylephrine to clear up stuffy noses. Some of the most widely used decongestants don’t work, several studies have found, prompting doctors and researchers to call for ending sales of the drugs. Versions of Benadryl, Mucinex and Tylenol, which more people are taking now as reports of respiratory infections increase, are among dozens of over-the-counter pills, syrups and liquids that rely on an ingredient called phenylephrine to clear up stuffy noses. The ingredient has proven safe, but at least four studies have found the medicines don’t relieve congestion.

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