April 12, 2016 — The FDA is evaluating the need for regulatory action based on reports of kidney failure from diabetes drugs in the DPP-4 inhibitor class.
The agency has a system to flag potential safety risks based on side effect reports submitted by doctors, patients, pharmacists, drug-makers, attorneys, and others. Placing a drug on the “watch list” does not mean it causes the side effect. However, the FDA may decide to strengthen warning labels or take the drug off the market.
In the second quarter of 2015, DPP-4 inhibitors were linked to a potential signal of kidney failure in the “Potential Signals of Serious Risks/New Safety Information Identified by FAERS, July–September 2015.”
The FDA is also investigating the risk of mouth ulceration and stomatitis from DPP-4 inhibitors. These side effects were added to the labels on diabetes drugs containing linagliptin (Glyxabmi, Tradjenta, Jentadueto).
Medscape reports that the FDA sometimes buries possible drug-risks in delayed “watch lists.” For example, the agency is also investigating the risk of stroke and thromboembolic events from diabetes drugs in the SGLT-2 inhibitor class, but waited seven months to report the investigation publicly.
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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