Onglyza, Nesina, Januvia, and Tradjenta Are Included In This Popular Class Of Type-2 Diabetes Medications
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)
In connection with that DPP-4 diabetes drug label change as well as related earlier FDA actions, some medical researchers recently took a look at heart-related side effects reports submitted to FDA Adverse Event Reporting System (FAERS) from 2006 to 2015.
From the Abstract for a subsequent medial journal article with their findings, in the Conclusions section:
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)].
That article, "Cardiovascular safety signals with dipeptidyl peptidase‐4 inhibitors: A disproportionality analysis among high‐risk patients", was published April 14, 2018 by the Pharmacoepidemiology & Drug Safety medical journal.
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Again drawing from the article's Abstract, this time in the Results section:
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].
Comparing these recent findings to the increased drug label warnings about heart failure which were mandated by the FDA for certain DPP-4 diabetes drugs back in 2016:
- It seems that Tradjenta and Jentadueto could have had similar increased warnings for heart failure added in April 2016 rather than in August 2017 -- and this type of label change for Glyxambi was not made until December 2017;
- It is suggested that Nesina, Kazano, and Oseni should have stronger warnings for myocardial infarction (MI), more commonly referred to as heart attack; and,
- It is suggested that Januvia, Janumet, and Janumet XR should have stronger warnings for cerebral infarction, more generally known as cerebrovascular accident (CVA) or stroke.
We would be interested in reviewing events of heart failure, myocardial infarction, and cerebral infarction for patients who used any of the DPP-4 diabetes drugs -- like Onlgyza, Nesina, Januvia, and Tradjenta -- as possible drug injury lawsuits against the responsible drug companies. (Get a Free Diabetes Drugs Case Evaluation)
Of course, 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.
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