April 12, 2016 — The FDA is investigating adverse event reports linking diabetes drugs in the DPP-4 inhibitor class with a possible increased risk of kidney failure.
The FDA has placed the drugs on a “watch list” and will evaluate the need for regulatory action, which could involve new warnings or additional studies. In very rare cases, the agency removes dangerous drugs from the market.
A federal law passed in 2007 requires the FDA to routinely screen its database of adverse events to help identify new side effects as they emerge. Instead, the agency sometimes delays reporting possible side effects, according to Medscape. For example, it took the FDA seven months to report an investigation into strokes and thromboembolic events associated with diabetes drugs in the SGLT2 inhibitor class.
Last year, diabetes drugs in the DPP-4 inhibitor class were associated with kidney failure in the quarterly report “Potential Signals of Serious Risks/New Safety Information Identified by FAERS, July–September 2015.”
The FDA also opened an investigation into ulceration and stomatitis from DPP-4 inhibitors. Those side effects were added to the label on diabetes drugs containing linagliptin, including Glyxambi, Tradjenta, and Jentadueto.
Dipeptidyl peptidase IV (DPP-IV) inhibitors include:
- Glyxambi (empagliflozin/linagliptin)
- Janumet XR (sitagliptin/metformin HCl)
- Janumet (sitagliptin/metformin HCl)
- Januvia (sitagliptin)
- Jentadueto (linagliptin/metformin HCl)
- Kazano (alogliptin/metformin HCl)
- Kombiglyze XR (saxagliptin/metformin HCl)
- Nesina (alogliptin)
- Onglyza (saxagliptin)
- Oseni (alogliptin/pioglitazone)
- Tradjenta (linagliptin)
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