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.
Free Diabetes Drugs Case Evaluation
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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)
- Rhabdomyolysis
- Unexpected Death
- Acute Pancreatitis
- Severe Joint Pain
Most Recent Article About These Drugs
DPP-4 Inhibitor Diabetes Drugs Linked To Inflammatory Bowel Disease
The use of DPP-4 inhibitor diabetes drugs is associated with increased risk for inflammatory bowel disease (IBD). This is according to an observational study published on March 21, 2018 by The BMJ medical journal article.
From the Discussion part of this March 2018 BMJ article,
To read more of this article, click below:
“Dipeptidyl peptidase-4 inhibitors and incidence of inflammatory bowel disease among patients with type 2 diabetes: population based cohort study”:
Use of dipeptidyl peptidase-4 inhibitors was associated with an overall 75% increase in risk of inflammatory bowel disease. In secondary analyses, the association was particularly elevated between three and four years of use and between two and four years after the start of dipeptidyl peptidase-4 inhibitor treatment. This gradual increase in the risk is consistent with the hypothesis of a possible delayed effect of the use of dipeptidyl peptidase-4 inhibitors on the incidence of inflammatory bowel disease.
The following relative new medicines are classified as DPP-4 inihibitor diabetes drugs:
Januvia (sitagliptin)
Janumet (sitagliptin / metformin HCl)
Janumet XR (sitagliptin / metformin HCl)
Tradjenta (linagliptin)
Jentadueto (linagliptin / metformin HCl)
Glyxambi (empagliflozin / linagliptin)
Onglyza (saxagliptin)
Kombiglyze XR (saxagliptin and metformin)
Qtern (dapagliflozin and saxagliptin)
Nesina (alogliptin)
Kazano (alogliptin and metformin)
Oseni (alogliptin and pioglitazone)
We will continue to monitor the safety profile of these DPP-4 inhibitor diabetes drugs.
[Read article in full at original source]Other articles by attorney Tom Lamb on the Side Effects Blog:
- 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
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All content by attorney Tom Lamb