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Diabetes Drugs Containing Saxagliptin Or Alogliptin: Risks Of Heart Failure And Kidney Or Renal Failure As Well As Other Serious Side Effects
We are investigating the following serious side effects associated with numerous different diabetes drugs:
- Heart Failure
- Renal Failure / Kidney Failure
- Kidney Problems
- Decreased Renal Function
- Unexpected Death
- Acute Pancreatitis
- Severe Joint Pain
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In April 2016 the FDA took regulatory action by mandating that the pharmaceutical companies AstraZeneca and Takeda make label changes with new warnings about an increased risk of heart failure for these relatively new diabetes drugs:
- AstraZeneca’s Onglyza (saxagliptin)
- AstraZeneca’s Kombiglyze XR (saxagliptin and metformin)
- Takeda’s Nesina (alogliptin)
- Takeda’s Kazano (alogliptin and metformin)
- Takeda’s Oseni (alogliptin and pioglitazone)
And in March 2016 we learned that the FDA is evaluating the need for regulatory action for the following group of dipeptidyl peptidase-4 (DPP-4) inhibitor drugs due to the side effects of renal failure or kidney failure:
Onglyza (saxagliptin)
Kombiglyze XR (saxagliptin/metformin HCl)
Nesina (alogliptin)
Kazano (alogliptin/metformin HCl)
Oseni (alogliptin/pioglitazone)
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.
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Diabetes Drugs Side Effects Case Evaluation
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FDA Says Onglyza And Nesina Increase Risks of Heart And Renal Failures
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.
[Read this article in full at original source]
Other articles by attorney Tom Lamb on the Side Effects Blog:
- 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
- Cardiovascular Safety Issues For Onglyza And Kombiglyze Will Be Discussed At April 2015 FDA Advisory Committee Meeting
- Possible Link Between Heart Failure And Onglyza Diabetes Type 2 Drug Is Being Investigated By FDA, As Announced In February 2014
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All content by attorney Tom Lamb