FDA links Januvia to pancreatitis - FiercePharma

Links shared publicly online about this topic.

  • 1,711
    total visits

FDA links Januvia to pancreatitis - FiercePharma

fiercepharma.com

Concerned by post-marketing cases of pancreatitis, FDA is adding the reports to labeling on Merck's (MRK) diabetes drug Januvia (sitagliptin) and a combo form of the drug, Janumet. The agency is... Read more...

View full resource at fiercepharma.com

Tags: Diabetes, Diabetes Type 2 Medication, Diabetes Medication, Drug, FDA, Januvia, Merck & Co.

  • Share

Most Recently Shared on September 30, 2009 at 6:48 pm By:

Merck Gets FDA Warning Letter on Drug Study - WSJ.com

online.wsj.com — “The FDA said Merck failed to meet a requirement to conduct a safety study in rodents of its blockbuster diabetes drug Januvia.View full resource at online.wsj.com

  • View Related
  • Share

Most Recently Shared on February 29, 2012 at 12:46 pm By:

FiercePharma FiercePharma Health Site

FDA chides Merck to follow up on post-marketing Januvia study. Testing in rodents for pancreatitis risk—WSJ http://t.co/yZgD0xfj $MRK

2 months ago...

UPDATE 2-Lilly pancreas drug raises questions-US FDA staff | Reuters

reuters.com — “* FDA staff question efficacy of Lilly's liprotamase * Drug would be first such medicine not made from pigs * Lilly shares slip 0.4 pct in morning trading * U.S. liprotamase sales seen $300 mln inView full resource at reuters.com

  • View Related
  • Share

Most Recently Shared on January 10, 2011 at 4:17 pm By:

ReutersDChealth Susan Heavey Health Communicator

$LLY seeks US OK for 1st pancreatic drug that's not made from pigs, but #FDA staff question how well it works:http://link.reuters.com/kex55r

1 year ago...

No pancreatitis risk seen in Byetta, Januvia drugs http://link.reuters.com/wem64m

reuters.com — “No pancreatitis risk seen in Byetta, Januvia drugs http://link.reuters.com/wem64mView full resource at reuters.com

  • View Related
  • Share

Most Recently Shared on June 28, 2010 at 10:06 pm By:

NewLink Genetics Receives Special Protocol Assessment Approval From FDA For Pivotal Phase 3 Trial In Pancreatic Cancer

medicalnewstoday.com — “NewLink Genetics Corporation announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for a pivotal Phase 3 triaView full resource at medicalnewstoday.com

  • View Related
  • Share

Most Recently Shared on February 12, 2010 at 3:10 pm By:

mnt_pharma MNT Pharma News Pharma and Health News

NewLink Genetics Receives Special Protocol Assessment Approval From FDA For Pivotal Phase 3 Trial In Pancreatic Cancer http://mnt.to/3xy5

2 years ago...

NewLink Genetics receives FDA SPA approval for HyperAcute immunotherapy Phase 3 pancreatic cancer trial

news-medical.net — “NewLink Genetics Corporation announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for a pivotal Phase 3 trial of its HyperAcute immunotherapy in pancreatic cancer. Pancreatic cancer is highly lethal and is currently an area of very significant unmet medical need. The SPA is a written agreement between NewLink as the trial sponsor and the FDA regarding the design, endpoints, and planned statistical analysis ofView full resource at news-medical.net

  • View Related
  • Share

Most Recently Shared on February 12, 2010 at 9:30 am By:

Genetics_News News-Medical.Net Health News

Genetics News: NewLink Genetics receives FDA SPA approval for HyperAcute immunotherapy Phase 3 pancreatic cancer... http://buzzup.com/o1h8

2 years ago...

BYETTA RED CODED - TuDiabetes

tudiabetes.com — “KIDNEY FAILURE Health Sciences Institute: Code Red Alert - Why am I getting this? The FDA Really Does Hate Diabetics Killer diabetes drug Byetta has once again been linked to severe organ damage and death... and the FDA has once again made them (can you guess?) change the warning label. Last year, it was increased risk of hemorrhagic pancreatitis (which caused several deaths) that got added to the label. This year, it's kidney problems " including 62 cases of acute kidney failure " which can be View full resource at tudiabetes.com

  • View Related
  • Share

Most Recently Shared on November 6, 2009 at 3:31 am By:

tudiabetes a diabetes community Support

Type 1 diabetes: BYETTA RED CODED: KIDNEY FAILURE Health Sciences Institute: Code Red Alert -.. http://bit.ly/gvY93

2 years ago...

BYETTA CAUSING KIDNEY FAILURE - TuDiabetes

tudiabetes.com — “Health Sciences Institute: Code Red Alert - Why am I getting this? The FDA Really Does Hate Diabetics Killer diabetes drug Byetta has once again been linked to severe organ damage and death... and the FDA has once again made them (can you guess?) change the warning label. Last year, it was increased risk of hemorrhagic pancreatitis (which caused several deaths) that got added to the label. This year, it's kidney problems " including 62 cases of acute kidney failure " which can be fatal. What wilView full resource at tudiabetes.com

  • View Related
  • Share

Most Recently Shared on November 6, 2009 at 3:17 am By:

tudiabetes a diabetes community Support

TuDiabetes blogs: BYETTA CAUSING KIDNEY FAILURE: Health Sciences Institute: Code Red Alert -.. http://bit.ly/1oakq0

2 years ago...

FDA sees pancreatitis link with Merck's Januvia - TuDiabetes

tudiabetes.com — “WASHINGTON, Sept 25 (Reuters) - U.S. health officials said on Friday they suspect Merck & Co Inc's (MRK.N) blockbuster diabetes drug Januvia may be linked to serious cases of inflamed pancreas, but company officials disputed the connection. The Food and Drug Administration said that 88 cases of acute pancreatitis had been reported since the drug's approval in 2006 through February 2009. More details: http://www.reuters.com/article/governmentFilingsNews/idUSN2550919420090925View full resource at tudiabetes.com

  • View Related
  • Share

Most Recently Shared on September 30, 2009 at 12:38 am By:

tudiabetes a diabetes community Support

Diabetes news: FDA sees pancreatitis link with Merck's Januvia: WASHINGTON, Sept 25 (Reuters) -.. http://bit.ly/2fGiiO

3 years ago...

FDA sees pancreatitis link with Merck's Januvia - TuDiabetes

tudiabetes.com — “WASHINGTON, Sept 25 (Reuters) - U.S. health officials said on Friday they suspect Merck & Co Inc's (MRK.N) blockbuster diabetes drug Januvia may be linked to serious cases of inflamed pancreas, but company officials disputed the connection. The Food and Drug Administration said that 88 cases of acute pancreatitis had been reported since the drug's approval in 2006 through February 2009. More details: http://www.reuters.com/article/governmentFilingsNews/idUSN2550919420090925View full resource at tudiabetes.com

  • View Related
  • Share

Most Recently Shared on September 29, 2009 at 7:22 pm By:

Januvia Linked to Pancreatitis by FDA - Health Blog - WSJ

blogs.wsj.com — “An FDA notice on Merck's Januvia comes just over a year after Byetta was also linked to pancreatitis.View full resource at blogs.wsj.com

  • View Related
  • Share

Most Recently Shared on September 28, 2009 at 8:27 pm By:

Sitagliptin linked to acute pancreatitis, FDA warns

theheart.org — “The FDA is revising prescribing information for sitagliptin and sitagliptin/metformin after cases of acute pancreatitis, some severe, surfaced in postmarketing reports.View full resource at theheart.org

  • View Related
  • Share

Most Recently Shared on September 28, 2009 at 5:44 pm By:

theheartorg Shelley Wood Cardiology

heartwire: Sitagliptin linked to acute pancreatitis, FDA warns http://bit.ly/2ZBLGp

3 years ago...

If you take Januvia or Janumet check out this link... - TuDiabetes

tudiabetes.com — “If you take Januvia or Janumet check out this link... http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm183764.htmView full resource at tudiabetes.com

  • View Related
  • Share

Most Recently Shared on September 28, 2009 at 9:03 am By:

tudiabetes a diabetes community Support

Type 1 diabetes: If you take Januvia or Janumet check out this link...: If you take Januvia o.. http://bit.ly/3pI80t

3 years ago...

FDA Alert: Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitis

drugs.com — “FDA Alert: Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitisView full resource at drugs.com

  • View Related
  • Share

Most Recently Shared on September 26, 2009 at 7:03 pm By:

pgoode Patricia Goode Nurse

FDA notified healthcare professionals of revisions to include information on reported cases of acute pancreatitis....http://short.to/rthu

3 years ago...

FDA Alert: Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitis

drugs.com — “FDA Alert: Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitisView full resource at drugs.com

  • View Related
  • Share

Most Recently Shared on September 26, 2009 at 4:42 am By:

drugscom Drugs.com Health Site

FDA Alert - FDA Revises Januvia/Janumet Prescribing Information to Include Reported Cases of Acute Pancreatitis - http://bit.ly/QlRRO

3 years ago...

FDA warns of acute pancreatitis with sitagliptin - MPR

empr.com — “The FDA has notified healthcare professional and patients of revisions to the prescribing information for Merck's Januvia (sitagliptin tablets) and Janumet (sitagliptin/metformin tablets) to include information on reported cases of acute pancreatitis in patients treated with these medications.View full resource at empr.com

  • View Related
  • Share

Most Recently Shared on September 25, 2009 at 4:45 pm By:

eMPR MPR Medical Publisher

MPR News: FDA warns of acute pancreatitis with sitagliptin: The FDA has notified healthcare profession.. http://bit.ly/18SK8N

3 years ago...

Advertisement