* . *
  • About
  • Advertise
  • Privacy & Policy
  • Contact
Tuesday, September 2, 2025
Earth-News
  • Home
  • Business
  • Entertainment
    Liam Payne’s Cousin Ross Harris Honors Late Singer With Emotional Song ‘Bones’ – yahoo.com

    Liam Payne’s Cousin Ross Harris Honors Late Singer with Emotional New Song ‘Bones

    Country music star apologizes after drunken show ends with cops taking him down: ‘I’m not OK’ – PennLive.com

    Country Music Star Apologizes After Drunken Show Ends in Police Intervention: ‘I’m Not OK

    Comanche Nation Entertainment closes casino near Devol – KSWO 7News

    Comanche Nation Entertainment Closes Casino Near Devol in Surprising Move

    Erykah Badu Announces ‘Abi & Alan’ Album With The Alchemist Will Be Delayed – yahoo.com

    Erykah Badu Opens Up About the Delay of Her Highly Anticipated ‘Abi & Alan’ Album with The Alchemist

    If You Needed Some BTS Pics Of The Rock’s Tree Trunk Legs To Spice Up Your Day, We Got ‘Em – yahoo.com

    Need a Boost? Check Out These Epic BTS Shots of The Rock’s Tree Trunk Legs!

    Sabrina Carpenter’s pearl-clutching magic? Humor – CNN

    Sabrina Carpenter’s pearl-clutching magic? Humor – CNN

  • General
  • Health
  • News

    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology
    China’s CATL sells stake in Finnish subcontract car manufacturer – Reuters

    China’s CATL Sells Stake in Finnish Auto Supplier in Strategic Move

    This Secret Technology Will Make The IPhone 17 Super Thin Air – VOI.ID

    How This Breakthrough Technology Will Make the iPhone 17 Incredibly Thin and Lightweight

    Gator football kicks off with excitement and new technology – WCJB | TV20

    Gator Football Kicks Off with Thrilling Action and Innovative Technology

    Marvell Technology (MRVL) Loses 18.6% as Growth Outlook Fails to Impress – Yahoo Finance

    Marvell Technology (MRVL) Loses 18.6% as Growth Outlook Fails to Impress – Yahoo Finance

    Propelling solar technology into a perovskite future – CORDIS

    Propelling solar technology into a perovskite future – CORDIS

    13 Top Technology Trends (2025) – Exploding Topics

    13 Game-Changing Technology Trends to Watch in 2025

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
  • Home
  • Business
  • Entertainment
    Liam Payne’s Cousin Ross Harris Honors Late Singer With Emotional Song ‘Bones’ – yahoo.com

    Liam Payne’s Cousin Ross Harris Honors Late Singer with Emotional New Song ‘Bones

    Country music star apologizes after drunken show ends with cops taking him down: ‘I’m not OK’ – PennLive.com

    Country Music Star Apologizes After Drunken Show Ends in Police Intervention: ‘I’m Not OK

    Comanche Nation Entertainment closes casino near Devol – KSWO 7News

    Comanche Nation Entertainment Closes Casino Near Devol in Surprising Move

    Erykah Badu Announces ‘Abi & Alan’ Album With The Alchemist Will Be Delayed – yahoo.com

    Erykah Badu Opens Up About the Delay of Her Highly Anticipated ‘Abi & Alan’ Album with The Alchemist

    If You Needed Some BTS Pics Of The Rock’s Tree Trunk Legs To Spice Up Your Day, We Got ‘Em – yahoo.com

    Need a Boost? Check Out These Epic BTS Shots of The Rock’s Tree Trunk Legs!

    Sabrina Carpenter’s pearl-clutching magic? Humor – CNN

    Sabrina Carpenter’s pearl-clutching magic? Humor – CNN

  • General
  • Health
  • News

    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology
    China’s CATL sells stake in Finnish subcontract car manufacturer – Reuters

    China’s CATL Sells Stake in Finnish Auto Supplier in Strategic Move

    This Secret Technology Will Make The IPhone 17 Super Thin Air – VOI.ID

    How This Breakthrough Technology Will Make the iPhone 17 Incredibly Thin and Lightweight

    Gator football kicks off with excitement and new technology – WCJB | TV20

    Gator Football Kicks Off with Thrilling Action and Innovative Technology

    Marvell Technology (MRVL) Loses 18.6% as Growth Outlook Fails to Impress – Yahoo Finance

    Marvell Technology (MRVL) Loses 18.6% as Growth Outlook Fails to Impress – Yahoo Finance

    Propelling solar technology into a perovskite future – CORDIS

    Propelling solar technology into a perovskite future – CORDIS

    13 Top Technology Trends (2025) – Exploding Topics

    13 Game-Changing Technology Trends to Watch in 2025

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
Earth-News
No Result
View All Result
Home Health

FDA Slaps Boxed Warning on Osteoporosis Drug

January 19, 2024
in Health
FDA Slaps Boxed Warning on Osteoporosis Drug
Share on FacebookShare on Twitter

The FDA added a boxed warning to the label of the osteoporosis drug denosumab (Prolia) over the risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD), the agency announced Friday.

After a review of the evidence, including new data published in JAMA, the FDA determined that denosumab can increase the risk for severe hypocalcemia compared with bisphosphonates in patients with advanced CKD, especially those on dialysis. Patients on dialysis or with mineral and bone disorder (MBD) have the highest risk of very low blood calcium levels.

The new data, which involved women on dialysis, showed that 41% developed severe hypocalcemia during the first 12 weeks of denosumab treatment, compared with 2.0% of those taking oral bisphosphonates.

The FDA’s “most prominent” warning, the boxed warning lists the potential for serious harm from severe hypocalcemia. This could include hospitalization, life-threatening events, and death in patients with advanced CKD taking denosumab. Severe hypocalcemia can also be asymptomatic or can present with symptoms like confusion, seizures, irregular heart rhythm, fainting, face twitching, uncontrolled muscle spasms, or weakness, tingling, or numbness in parts of the body.

As part of its new drug safety communication, the FDA advised clinicians to carefully select appropriate patients for this treatment and increase monitoring of blood calcium levels, particularly for the first 2 to 10 weeks after each injection. Calcium and vitamin D supplements may also be required.

Prior to prescribing denosumab, clinicians should assess their patients’ kidney function and consider the risk of severe hypocalcemia with denosumab in the context of other available treatments for osteoporosis for patients with advanced CKD — especially those on dialysis.

“If Prolia is still being considered for these patients, for initial or continued use, check their calcium blood levels and assess them for evidence of CKD-MBD,” the FDA advised.

Patients taking denosumab shouldn’t stop their medication without first consulting with their healthcare provider.

The label update comes after the FDA initially issued a safety alert in November 2022 about denosumab’s potential hypocalcemia risk in dialysis-dependent women. The safety alert was prompted after interim results from maker Amgen’s ongoing safety study — required upon approval — that indicated an increased risk of hypocalcemia in patients with advanced kidney disease.

The drug was first approved in 2010 for postmenopausal women with osteoporosis at high risk for bone fracture and later picked up indications to treat men with osteoporosis, glucocorticoid-induced osteoporosis, and bone loss in those receiving androgen-deprivation therapy for prostate cancer and for women receiving aromatase inhibitor therapy for breast cancer. (Denosumab is also approved under the trade name Xgeva to reduce the risk of bone-related events in certain cancer patients.)

Administered via injection every 6 months, the treatment works by blocking the protein receptor activator of nuclear factor kappa beta (RANK) and prevents osteoclasts from breaking down bone in the body.

The FDA asked patients and healthcare professionals to report side effects involving denosumab to the agency’s MedWatch program.

author['full_name']

Kristen Monaco is a senior staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, she’s worked at the company since 2015.

>>> Read full article>>>
Copyright for syndicated content belongs to the linked Source : MedPageToday – https://www.medpagetoday.com/endocrinology/osteoporosis/108332

Tags: Boxedhealthslaps
Previous Post

First-Ever Experiment Shows How Pigs Could One Day Help Liver Failure Patients

Next Post

Is Palworld cross-platform?

Russia and China redouble their efforts to reshape the world order – CNN

Russia and China redouble their efforts to reshape the world order – CNN

September 2, 2025
How Bad Bunny’s Puerto Rico Residency is Boosting the Economy – The New York Times

How Bad Bunny’s Puerto Rico Residency is Sparking a Local Economic Boom

September 2, 2025
Liam Payne’s Cousin Ross Harris Honors Late Singer With Emotional Song ‘Bones’ – yahoo.com

Liam Payne’s Cousin Ross Harris Honors Late Singer with Emotional New Song ‘Bones

September 2, 2025
Trump quashes health concerns on Truth Social, ‘never felt better in my life’ and tees up next battle with Fed’s Lisa Cook – Fortune

Trump Denies Health Rumors, Says He’s ‘Never Felt Better’ as He Gears Up for Next Showdown with Fed’s Lisa Cook

September 2, 2025
The 1600: The Hell-Cycle of Political Prosecutions – Newsweek

The 1600: The Hell-Cycle of Political Prosecutions – Newsweek

September 2, 2025
Construction of forest ecological security patterns based on MSPA model and circuit theory in the Desertification Control forests in South China Karst – Nature

Construction of forest ecological security patterns based on MSPA model and circuit theory in the Desertification Control forests in South China Karst – Nature

September 2, 2025
Bringing life science to life: Park Crossing teacher recognized – WSFA

Bringing life science to life: Park Crossing teacher recognized – WSFA

September 2, 2025
Take flight: EH seventh-graders learn science through paper airplanes – The Daily Reporter – Greenfield Indiana

Soar to New Heights: Seventh-Graders Explore Science with Paper Airplanes

September 2, 2025
Marcos orders lifestyle audit of all government officials — Dateline Philippines – Asian Journal News

Marcos Initiates Comprehensive Lifestyle Audit of Government Officials to Boost Accountability

September 2, 2025
China’s CATL sells stake in Finnish subcontract car manufacturer – Reuters

China’s CATL Sells Stake in Finnish Auto Supplier in Strategic Move

September 2, 2025

Categories

Archives

September 2025
MTWTFSS
1234567
891011121314
15161718192021
22232425262728
2930 
« Aug    
Earth-News.info

The Earth News is an independent English-language daily published Website from all around the World News

Browse by Category

  • Business (20,132)
  • Ecology (802)
  • Economy (821)
  • Entertainment (21,701)
  • General (16,809)
  • Health (9,862)
  • Lifestyle (835)
  • News (22,149)
  • People (822)
  • Politics (829)
  • Science (16,031)
  • Sports (21,319)
  • Technology (15,801)
  • World (802)

Recent News

Russia and China redouble their efforts to reshape the world order – CNN

Russia and China redouble their efforts to reshape the world order – CNN

September 2, 2025
How Bad Bunny’s Puerto Rico Residency is Boosting the Economy – The New York Times

How Bad Bunny’s Puerto Rico Residency is Sparking a Local Economic Boom

September 2, 2025
  • About
  • Advertise
  • Privacy & Policy
  • Contact

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

Go to mobile version