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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
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:
Kombiglyze XR (saxagliptin/metformin HCl)
Kazano (alogliptin/metformin HCl)
Janumet XR (sitagliptin/metformin HCl)
Janumet (sitagliptin/metformin HCl)
Jentadueto (linagliptin/metformin HCl)
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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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:
- Glyxambi (empagliflozin and linagliptin) tablets
- Janumet (sitagliptin and metformin hydrochloride) tablets
- Janumet XR (sitagliptin and metformin hydrochloride extended-release) tablets
- Januvia (sitagliptin) tablets
- Jentadueto (linagliptin and metformin hydrochloride) tablets
- Jentadueto XR (linagliptin and metformin hydrochloride extended-release) tablets
- Kazano (alogliptin and metformin hydrochloride) tablets
- Kombiglyze XR (saxagliptin and metformin hydrochloride extended-release) tablets
- Nesina (alogliptin) tablets
- Onglyza (saxagliptin) tablets
- Oseni (alogliptin and pioglitazone) tablets
- Qtern (dapagliflozin and saxagliptin) tablets
- 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.
- 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
- Cardiovascular Safety Issues For Onglyza And Kombiglyze Will Be Discussed At April 2015 FDA Advisory Committee Meeting
All content by attorney Tom Lamb