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]
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