Heart Failure or Kidney Problems: Onglyza / Kombiglyze / Nesina / Kazano / Oseni / Glyxambi / Janumet / Januvia / Jentadueto / Tradjenta
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FDA Regulatory Action: Heart Failure
In April 2016 the FDA took regulatory action by mandating label changes with new warnings about an increased risk of heart failure for these relatively new diabetes medicines in the dipeptidyl peptidase-4 (DPP-4) inhibitor drug class:
- Onglyza (saxagliptin)
- Kombiglyze XR (saxagliptin and metformin)
- Nesina (alogliptin)
- Kazano (alogliptin and metformin)
- Oseni (alogliptin and pioglitazone)
- Qtern (dapagliflozin and saxagliptin)
Similar increased warnings for heart failure were added in August 2017 for two more DPP-4 diabetes drugs:
- Tradjenta (linagliptin)
- Jentadueto (linagliptin and metformin HCl)
And this heart failure label change for Glyxambi (linagliptin and empagliflozin) was not made until December 2017.
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FDA Investigations: Kidney Failure; Joint Pain
In March 2016 the FDA said it was evaluating the need for possible regulatory action as regards the several dipeptidyl peptidase-4 (DPP-4) inhibitor drugs listed above as well as the following set of DPP-4 diabetes drugs due to the side effects of renal failure or kidney failure:
- Glyxambi (empagliflozin / linagliptin)
- Janumet XR (sitagliptin / metformin HCl)
- Janumet (sitagliptin / metformin HCl)
- Januvia (sitagliptin)
- Jentadueto (linagliptin / metformin HCl)
- Tradjenta (linagliptin)
Lastly, back in August 2015 the FDA announced that it found indications of a new side effect for the dipeptidyl peptidase-4 (DPP-4) inhibitors class of diabetes medications, based on drug adverse event reports of arthralgia, or severe pain in one or more joints. According to the FDA, patients started having symptoms of this severe joint pain side effect from one day to years after they started taking one of these diabetes drugs.
Other Side Effects
In addition to the aforementioned side effects of heart failure and kidney problems, we are also investigating the following serious side effects associated with these dipeptidyl peptidase-4 (DPP-4) inhibitor diabetes drugs:
- Myocardial Infarction (MI) / Heart Attacks
- Cerebral Infarction / Cerebrovascular Accident (CVA) / Strokes
- Inflammatory Bowel Disease (IBD)
- Unexpected Death
- Acute Pancreatitis
Most Recent Article About These Drugs
There is new medical research concerning pancreatic cancer linked to diabetes medicines in the DPP-4 inhibitor drug class.
In more detail, the use of dipeptidyl peptidase-4 inhibitors (DPP-4i) diabetes medicines may be associated with an increased risk for pancreatic cancer in patients with newly diagnosed type 2 diabetes. This finding comes from an August 20, 2019 article published online by the Diabetes Care medical journal.
To read more of this article, click below:
Some of the more popular diabetes medicines in the dipeptidyl peptidase-4 (DPP-4) inhibitor drug class are Onglyza (saxagliptin), Nesina (alogliptin), and Tradjenta (linagliptin).
From the Abstract for this Diabetes Care article, “Nationwide Trends in Pancreatitis and Pancreatic Cancer Risk Among Patients With Newly Diagnosed Type 2 Diabetes Receiving Dipeptidyl Peptidase-4 Inhibitors”, we get the following information:
CONCLUSIONS: DPP-4i use is associated with increased risks of pancreatitis and pancreatic cancer in patients with newly diagnosed type 2 diabetes. However, the absence of increasing trend according to exposure duration suggests the chances of reverse causality, and long-term pancreatic safety of DPP-4i has to be further investigated.
We are watching for further developments about pancreatic cancer linked to diabetes medicines such as Onglyza, Nesina, and Tradjenta, as well as other dipeptidyl peptidase-4 (DPP-4) inhibitor diabetes drugs.[Read article in full at original source]
Other articles by attorney Tom Lamb on the Side Effects Blog:
- Diabetes Drugs In DPP-4 Inhibitor Class Significantly Increase Risk Of Crohn’s Disease (CD)
- Certain Diabetes Drugs Side Effects Include Heart Attacks And Strokes
- DPP-4 Inhibitor Diabetes Drugs Linked To Inflammatory Bowel Disease
- Current Number Of Lawsuits Filed In Diabetes Drugs Federal Court MDL Cases
- Diabetes Drugs Kombiglyze And Onglyza MDL: Focus Is On Heart Failure
- Rhabdomyolysis May Be Linked To A New Class Of Oral Diabetes Medicines
- FDA Says Onglyza And Nesina Increase Risks of Heart And Renal Failures
- Diabetes Drugs Like Januvia Linked To Severe Joint Pain Side Effects
- FDA May Require New Onglyza Drug Label For Warning About Heart Failure
- Diabetes Drugs Kombiglyze And Onglyza: Heart Failure Side Effect Seems To Be Valid, And FDA Notes There Is A Possible Increased Risk Of All-Cause Mortality
All content by attorney Tom Lamb