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October 15, 2017 – According to the quarterly safety report April – June 2017 by the American Food & Drug Administration (FDA), originating from the FDA Adverse Event Reporting System (FAERS), the class of diabetes drugs referred to as dipeptidyl peptidase-4 inhibitors (DPP-IV inhibitors) may be associated with rhabdomyolysis, a severe,
sometimes fatal, adverse drug reaction, which involves severe muscle damage and may lead to renal and kidney failures. 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.
This most recent FDA quarterly report was issued in early October 2017. It states that “FDA is evaluating the need for regulatory action” as regards this possible rhabdomyolysis side effect for these oral diabetes drugs: Empagliflozin/Linagliptin (Glyxambi), Sitagliptin/Metformin (Janumet), Sitagliptin/Metformin (Janumet XR), Sitagliptin (Januvia), Linagliptin/Metformin(Jentadueto), Linagliptin/Metformin (Jentadueto XR), Alogliptin/Metformin (Kazano). Saxagliptin/Metformin (Kombiglyze XR), Alogliptin (Nesina), Saxagliptin (Onglyza), Alogliptin/Pioglitazone (Oseni), Dapagliflozin/Saxagliptin (Qtern), Linagliptin (Tradjenta).
In may be of particular interest to note that previously the FDA had announced that it was evaluating the need for regulatory action for the DPP-IV inhibitor class of diabetes medicines due to the serious side effect of renal and/or kidney failure, as announced in the quarterly report from July – September 2015. It would not be too surprising if most of these cases of renal and/or kidney failure had rhabdomyolysis as an underlying etiologic clinical factor.
DPP-IV inhibitors are often also referred to as gliptines. Besides the afore listed gliptines on the market in the United States, gliptines are on the market in other parts of the world as follows: Vildagliptin (Galvus) in the European Union ((EU), Gemigliptin (Zemiglo) in South Korea, Anagliptin, Teneligliptin, and Omarigliptin in Japan, and Evogliptin (approved for use in South Korea). Worldwide, this list may not be complete; however, it is fair to assume that all patients taking gliptine-type of drugs (i.e., DPP-IV inhibitors) may have a risk of being afflicted with rhabdomyolysis and ensuing renal and or kidney failures.
If there exist a genetic predisposition for the development of rhabdomyolysis after drug exposure is still at the research level. There seem to exist genetic factors that predispose patients for the development of rhabdomyolysis (even some inherited forms seem to exist); how drug exposure, in particular to DPP-IV inhibitors may influence the risk for development of rhabdomyolysis in carriers of such predisposing factors remains at present an open question.
Here, you may find all the FDA’s Quarterly Safety Reports since 2009 0n “Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)”.