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
Some medical researchers recently took a look at reports submitted to FDA Adverse Event Reporting System (FAERS) from 2006 to 2015 for the purpose of reviewing the dipeptidyl peptidase-4 (DPP-4) inhibitor class of diabetes drugs side effects.
An article which presented their findings, “Cardiovascular safety signals with dipeptidyl peptidase‐4 inhibitors: A disproportionality analysis among high‐risk patients”, was published in April 2018 by the Pharmacoepidemiology & Drug Safety medical journal.
To read more of this article, click below:
From the Abstract for this article, here are two excerpts:
- Postmarketing surveillance of DPP‐4i through FAERS suggest increased reporting of [major adverse cardiac events (MACE)], supporting the current FDA warning of heart failure risk. This suggests the need for additional longitudinal, observational research into the association of [dipeptidyl peptidase‐4 inhibitors (DPP‐4i)] and other [major adverse cardiac events (MACE)].
- In the cardiovascular subset, there was an [signal of disproportional reporting (SDR)] for heart failure with linagliptin [e.g., Tradjenta (linagliptin), Jentadueto (linagliptin / metformin HCl), and Glyxambi (linagliptin and empagliflozin)] and saxagliptin [e.g., Onglyza (saxagliptin), Kombiglyze XR (saxagliptin and metformin), and Qtern (saxagliptin and dapagliflozin)], myocardial infarction with alogliptin [e.g., Nesina (alogliptin), Kazano (alogliptin and metformin), and Oseni (alogliptin and pioglitazone)], and cerebral infarction with sitagliptin [e.g., Januvia (sitagliptin), Janumet (sitagliptin / metformin HCl), Juvisync (sitagliptin), and Steglujan (sitagliptin and ertugliflozin].
We will continue to monitor the safety profile for all the DPP-4 diabetes drugs and watch for future possible FDA regulatory actions, such as drug label changes with stronger warnings about heart attacks and/or strokes.[Read article in full at original source]
Other articles by attorney Tom Lamb on the Side Effects Blog:
- 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