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Pancreatic Cancer: Side Effect Of Onglyza, Nesina, Tradjenta, Other DPP-4 Inhibitor Diabetes Drugs?

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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.

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.

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Certain Diabetes Drugs Like Januvia Associated With Bile Duct Cancer

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The risk of developing bile duct cancer, also known as cholangiocarcinoma, is almost doubled for type 2 diabetics using one of the following diabetes medicines:

Januvia (sitagliptin)
Janumet (sitagliptin / metformin HCl)
Onglyza (saxagliptin)
Kombiglyze XR (saxagliptin and metformin)
Qtern (dapagliflozin and saxagliptin)
Nesina (alogliptin)
Kazano (alogliptin and metformin)
Oseni (alogliptin and pioglitazone)
Tradjenta (linagliptin)
Jentadueto (linagliptin and metformin HCl)
Glyxambi (empagliflozin / linagliptin)

These diabetes medicines are in the dipeptidyl peptidase-4 (DPP-4) inhibitor drug class.

In more detail, a BMJ article, “Incretin based drugs and risk of cholangiocarcinoma among patients with type 2 diabetes: population based cohort study”, published in December 2018, reports on a medical study whihch showed that the use of DPP-4 inhibitors diabetes drugs was associated with a near doubling of the risk of bile duct cancer.

This December 2018 BMJ medical journal article concluded with an important call-to-action:

Given the high fatality rate of this cancer, post hoc analyses of randomised controlled trials and additional observational studies are needed to corroborate our findings.

We will continue to monitor the medical literature for more about bile duct cancer being a possible side effect of DPP-4 inhibitor diabetes drugs.

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Certain Diabetes Drugs Side Effects Include Heart Attacks And Strokes

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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.

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.

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DPP-4 Inhibitor Diabetes Drugs Linked To Inflammatory Bowel Disease

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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, “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 inhibitor 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 diabetes drugs.

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Diabetes Drugs Kombiglyze And Onglyza MDL: Focus Is On Heart Failure

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A Kombiglyze and Onglyza MDL for federal court lawsuits filed against AstraZeneca and Bristol-Myers Squibb will focus on heart failure cases among other side effects associated with these diabetes drugs.

As background, 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 class of drugs:

  • Onglyza (saxagliptin)
  • Kombiglyze XR (saxagliptin and metformin)
  • Nesina (alogliptin)
  • Kazano (alogliptin and metformin)
  • Oseni (alogliptin and pioglitazone)
  • Qtern (dapagliflozin and saxagliptin)

In February 2018 the United States Judicial Panel on Multidistrict Litigation (JPML) established MDL No. 2809, IN RE: ONGLYZA (SAXAGLIPTIN) AND KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN) PRODUCTS LIABILITY LITIGATION.

According to that JPML Transfer Order the Defendants — AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Co., and McKesson Corp. — opposed centralization of approximately 80 Onglyza and Kombiglyze lawsuits into this new MDL:

Defendants oppose transfer by arguing that plaintiffs’ allegations are supported by a single study (the SAVOR study), which itself supports only claims regarding heart failure – not the various other injuries (congestive heart failure, acute hypoxic respiratory failure, coronary artery disease and cardiovascular injury) plaintiffs allege….

Defendants concede that most cases involve allegations of heart failure, which is squarely in line with the results of the SAVOR study and the subsequent label change for Onglyza and Kombiglyze XR in April 2016.

As indicated above, MDL No. 2809 involves only Onglyza and Kombiglyze lawsuits filed in the federal court system. However, at the present time we are investigating heart failure cases for patients who used Onglyza or Kombiglyze as well as patients who used Nesina, Kazano, Oseni, or Qtern.

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Rhabdomyolysis May Be Linked To A New Class Of Oral Diabetes Medicines

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A class of diabetes drugs referred to as dipeptidyl peptidase-4 inhibitors may be associated with rhabdomyolysis, a side effect which involves severe muscle damage.

In more detail, rhabdomyolysis is the breakdown of muscle tissue that leads to the release of muscle fiber contents into the blood. These substances are harmful to the kidney and often cause kidney damage.

According to a new FDA quarterly report, “Potential Signals of Serious Risks / New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): April – June 2017”, the following 13 oral diabetes medicines are being investigated for this possible rhabdomyolysis side effect:

  1. Glyxambi (empagliflozin and linagliptin) tablets
  2. Janumet (sitagliptin and metformin hydrochloride) tablets
  3. Janumet XR (sitagliptin and metformin hydrochloride extended-release) tablets
  4. Januvia (sitagliptin) tablets
  5. Jentadueto (linagliptin and metformin hydrochloride) tablets
  6. Jentadueto XR (linagliptin and metformin hydrochloride extended-release) tablets
  7. Kazano (alogliptin and metformin hydrochloride) tablets
  8. Kombiglyze XR (saxagliptin and metformin hydrochloride extended-release) tablets
  9. Nesina (alogliptin) tablets
  10. Onglyza (saxagliptin) tablets
  11. Oseni (alogliptin and pioglitazone) tablets
  12. Qtern (dapagliflozin and saxagliptin) tablets
  13. Tradjenta (linagliptin) tablets

We will be watching for reports of rhabdomyolysis in patients using Onglyza, Nesina, Januvia, and the other Type-2 diabetes drugs containing saxagliptin, alogliptin, sitagliptin, or linagliptin.

[Read article in full at original source]

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FDA Says Onglyza And Nesina Increase Risks of Heart And Renal Failures

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A recent April 2016 FDA action concerning Onglyza is an update to a February 11, 2014 FDA Drug Safety Communication, and now the FDA is warning about an increased risk of heart failure being linked to Nesina and other diabetes drugs containing alogliptin.

On April 5, 2016 the FDA took regulatory action by mandating that the pharmaceutical companies AstraZeneca and Takeda make label changes for some of their still relatively new diabetes drugs. This move was announced by means of “FDA Drug Safety Communication: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin”.

The diabetes drugs covered by this FDA action are:

  • AstraZeneca’s Onglyza (saxagliptin)
  • AstraZeneca’s Kombiglyze XR (saxagliptin and metformin extended release)
  • Takeda’s Nesina (alogliptin)
  • Takeda’s Kazano (alogliptin and metformin)
  • Takeda’s Oseni (alogliptin and pioglitazone)

Next we move to the increased risk of renal failure associated with Onglyza, Nesina, and the other diabetes medications containing saxagliptin and alogliptin, as well as some other drugs.

From this March 29, 2016 Medscape investigative report, “Possible Drug Risks Buried in Delayed FDA ‘Watch Lists'” we learned that the FDA is evaluating the need for regulatory action for the following group of 11 dipeptidyl peptidase IV (DPP-IV) inhibitor drugs due to the serious side effect of renal failure, or kidney failure:

Onglyza (saxagliptin) tablet
Kombiglyze XR (saxagliptin/metformin HCl) extended-release tablet
Nesina (alogliptin) tablet
Kazano (alogliptin/metformin HCl) tablet
Oseni (alogliptin/pioglitazone) tablet
Glyxambi (empagliflozin/linagliptin) tablet
Janumet XR (sitagliptin/metformin HCl) extended release tablet
Janumet (sitagliptin/metformin HCl) tablet
Januvia (sitagliptin) tablet
Jentadueto (linagliptin/metformin HCl) tablet
Tradjenta (linagliptin) tablet

We will continue to watch for reports of heart failure and kidney / renal failure in patients using Onglyza, Nesina, and the other Type-2 diabetes drugs containing saxagliptin and alogliptin.

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Law Offices of Thomas J. Lamb, P.A.
1908 Eastwood Road, Suite 225
Wilmington, North Carolina 28403
910-256-2971 | 800-426-9535
TJL@LambLawOffice.com