Food and Drug Administration

FDA announces recall of heart pumps linked to deaths and injuries

17Apr

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FDA announces recall of heart pumps linked to deaths and injuries

A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA's most serious recall, the agency announced Monday.The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories. The devices are not currently being removed from the market. In an emailed response, Abbott said it had communicated the risk to customers this year.The delayed action raises questions for some safety advocates about how and when issues with approved medical devices should be reported. The heart devices in question have been associated with thousands of reports of patients' injuries and deaths, as described in a KFF Health News investigation late last year. ...

FDA warns about Ozempic counterfeits, seizes thousands of fake drugs

23Dec

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FDA warns about Ozempic counterfeits, seizes thousands of fake drugs

Poison centers see spike weight-loss drug calls U.S. poison centers see spike in calls over weight-loss drugs 00:35 Federal officials are urging Ozempic users to check the legitimacy of their medications because of counterfeit versions of the popular diabetes drug that have been sold through legitimate sources. The Food and Drug Administration has seized "thousands of units" of counterfeit Ozempic 1 milligram injections in an investigation t...

Deep flaws in FDA oversight of medical devices — and patient harm — exposed in lawsuits and records

20Dec

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Deep flaws in FDA oversight of medical devices — and patient harm — exposed in lawsuits and records

Living with diabetes, Carlton "PeeWee" Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream.The pump, manufactured by device maker Medtronic, connected plastic tubing to an insulin reservoir, which Gautney set to release doses of the vital hormone over the course of the day. Gautney, a motorcycle enthusiast, worked as a dispatcher with the police department in Opp, Alabama.The 59-year-old died suddenly on May 17, 2020, because — his family believes — the pump malfunctioned and delivered a fatal overdose of insulin. "There's a big hole left where he was," said Gautney's daughter, Carla Wiggins, who is suing the manufacturer. "A big part of me is missing."The wrongful-death lawsuit alleges t...

Coca-Cola recalls 2,000 Diet Coke, Sprite, Fanta Orange soda packs

15Dec

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Coca-Cola recalls 2,000 Diet Coke, Sprite, Fanta Orange soda packs

Coca-Cola is recalling 2,000 cases of Diet Coke, Sprite and Fanta Orange soda cans because they may contain "foreign material."The recall comprises 12-packs of 12-ounce cans, including 1,557 packs of Sprite, 417 of Diet Coke and 14 of Fanta Orange. The cases were distributed in Alabama, Mississippi and Florida, an FDA filing shows. It remains unclear what the potential "foreign material" could be and what risks, if any, it poses to consumers. The FDA did not immediately respond to CBS MoneyWatch's request for comment. The recall includes:Diet Coke 12-packs marked with lot numbers JAN2924MBD3 and UPC 49000028911 and have a best-by date of Jan. 29, 2024. Fanta Orange 12-packs with lot numbers UL2924MBD3 and UPC 49000030730. Sprite 12-p...

Chinese and American Hospitals Learn the Value of Germs

27Nov

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Health

Chinese and American Hospitals Learn the Value of Germs

Here we go again. The World Health Organization on Nov. 22 said it is looking into media reports of Chinese hospitals overwhelmed by sick children. Chinese authorities attribute the surge to higher circulation of seasonal bugs like the flu and respiratory syncytial virus, or RSV. The reports have raised concerns about a potentially novel pathogen spreading in China and renewed suspicions about Beijing’s lack of transparency.“It is not at all clear when this outbreak started as it would be unusual for so many children to be affected so quickly,” the International Society for Infectious Diseases’ Program for Monitoring Emerging Diseases reported.Copyright ©2023 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

FDA warns about Neptune’s Fix tianeptine supplements after reports of seizures, hospitalizations

23Nov

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Health

FDA warns about Neptune’s Fix tianeptine supplements after reports of seizures, hospitalizations

The Food and Drug Administration is warning consumers not to use or purchase any products from the supplement brand called Neptune's Fix after receiving multiple reports of severe reactions, including seizures and hospitalizations. The FDA says it is testing samples for illegal and harmful ingredients.Neptune's Fix supplements purport to contain tianeptine, an opioid alternative prescribed as an antidepressant in some Latin American, Asian and European countries. Tianeptine is not approved for use in the U.S.The FDA has previously warned about this "potentially dangerous" substance, which the agency says has been linked to addiction and deadly overdoses. The FDA is warning consumers to not purchase or use Neptune's Fix products, or any other product with tianeptine, wh...

Nationwide recall of peaches, plums and nectarines linked to deadly listeria outbreak

21Nov

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Nationwide recall of peaches, plums and nectarines linked to deadly listeria outbreak

Peaches, plums and nectarines distributed by HMC Farms and sold nationwide as recently as last week are being recalled due to an outbreak of listeria that has resulted in 11 illnesses, including one death and 10 hospitalizations, federal safety regulators said Monday."Investigators are working to determine if any additional fruit or products made with this fruit may be contaminated," the U.S. Centers for Disease Control and Prevention stated in a food safety alert. Kingsburg, California-based HMC Farms is recalling peaches, plums and nectarines sold between May 1 and November 15 of this year as well as as during the same period in 2022, the company said in a notice posted Friday by the Food and Drug Administration. The FDA found listeria in testing a sample of HMC Farms peaches in late Oc...

14Nov

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Health

Biden’s Race Against a Cure

Updated Nov. 13, 2023 7:27 pm ETThe Food and Drug Administration may soon approve two gene therapies with the potential to cure more than 100,000 Americans with debilitating sickle-cell disease. Now the bad news: The Centers for Medicare and Medicaid Services (CMS) may soon limit access to such breakthrough treatments.Gene therapies fix missing or defective genes. The one-time treatments have the potential to cure inherited disorders with early death sentences. The FDA has approved nine gene therapies for such diseases as Duchenne muscular dystrophy, spinal muscular atrophy and retinal dystrophy. Copyright ©2023 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

FDA investigating reports of hospitalizations after fake Ozempic

12Nov

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Health

FDA investigating reports of hospitalizations after fake Ozempic

At least three Americans have been reported hospitalized after using suspected counterfeits of semaglutide drugs, which include Novo Nordisk's diabetes medication Ozempic, according to records released by the Food and Drug Administration. Ozempic and Wegovy, another semaglutide medication from Novo Nordisk, have been in short supply for months amid booming sales for their use in weight loss. The hospitalizations are among 42 reports to the FDA's Adverse Event Reporting System that mention use of counterfeit semaglutide from around the world. The agency last updated its database at the end of last month to include reports tallied through the end of September. Of the reports, 28 are classified as "serious" with outcomes that also include deaths. Only a po...

CVS is pulling some of the most popular cold medicines from store shelves. Here’s why.

19Oct

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CVS is pulling some of the most popular cold medicines from store shelves. Here’s why.

FDA panel: Common decongestant doesn't work FDA panel says decongestant in many cold medicines doesn't work 03:46 Pharmacy chain CVS Health said it is pulling some of its most popular cold and cough medications from store shelves, weeks after advisors to the Food and Drug Administration deemed a common ingredient ineffective.CVS told CBS MoneyWatch that it will no longer sell products that only contain phenylephrine as an active ingredient a...