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
The medical journal Annals of Pharmacotherapy has published an article, “Dipeptidyl Peptidase-4 Inhibitors and Inflammatory Bowel Disease Risk: A Meta-analysis”, which concludes that dipeptidyl peptidase-4 (DPP-4) inhibitors increase the risk of Crohn’s disease (CD). It goes on to point out that these Tyoe 2 diabetes drugs, such as Januvia, Onglyza, and Kombiglyze, do not appear to increase the risk of developing Inflammatory Bowel Disease (IBD).
To read more of this article, click below:
From the Abstract for this new Annals of Pharmacotherapy article, published on January 30, 2019, we get the following:
- Objective: This meta-analysis aims to elucidate the risk for [inflammatory bowel disease (IBD)] with DPP-4 inhibitor therapy.
- Results: A total of 16 individual studies evaluating a total of 198 404 patients were included for analysis. Studies ranged from 52 weeks through 5 years. In the primary random-effects analysis, DPP-4 inhibitor exposure resulted in a nonsignificant increase in the risk of [inflammatory bowel disease (IBD)] (RR = 1.52; 95% CI = 0.72 to 3.24; I2 = 54.2%)…. DPP-4 inhibitor use significantly increased the risk of [Crohn’s disease (CD)] (RR = 2.47; 95% CI = 1.36 to 4.48)….
- Conclusion and Relevance: Based on a conservative random-effects analysis, DPP-4 inhibitors do not appear to increase the risk of developing inflammatory bowel disease. However, long-term postmarketing surveillance is warranted.
In summary, this recent study found that the DPP-4 inhibitor class of drugs is not associated with IBD; however, DPP-4 inhibitor diabetes drugs, such as Januvia and Onglyza, increase the risk of Crohn’s disease (CD).[Read article in full at original source]
Other articles by attorney Tom Lamb on the Side Effects Blog:
- 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