Diabetes: Is rhabdomyolysis associated with DPP-IV inhibitors?

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,

Rhabdomyolysis

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)”.

 

____________________

 

Tags: , , , , , , , , , , , , , , , , , , , , , , , , ,
About the Author
Joseph Gut - thasso Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

Your opinion

Comment

No comments yet

thasso: conditions

thasso: newest tweets

thasso: recent comments

View my Flipboard Magazine.

thasso: categories

thasso: archives

thasso: simple chat

You must be a registered user to participate in this chat.

  • Silencing gene expression to cure complex diseases October 26, 2020
    Many people think of new medicines as bullets, and in the pharmaceutical industry, frequently used terms like "targets" and "hits" reinforce that idea. Immuneering co-founder and CEO Ben Zeskind '03, Ph.D. '06 prefers a different analogy.
  • Bits of genetic material called microRNAs may drive metabolic disorders October 26, 2020
    In a study published today in the journal Cell, UC Berkeley Nutritional Sciences and Toxicology professor Anders Näär led a group of researchers from 12 institutions in the United States and Europe, to better understand a region on the second human chromosome previously linked to both the digestion of milk and metabolic disorders. They discovered […]
  • New York City's coronavirus outbreak spread from more European sources than first reported October 26, 2020
    The COVID-19 pandemic started earlier than previously thought in New York City and Long Island by dozens of people infected mostly with strains from Europe. A new analysis also shows that most of the spread was within the community, as opposed to coming from people who had traveled.
  • Cause of Alzheimer's disease traced to mutation in common enzyme October 26, 2020
    Researchers from Tokyo Metropolitan University have discovered a new mechanism by which clumps of tau protein are created in the brain, killing brain cells and causing Alzheimer's disease. A specific mutation to an enzyme called MARK4 changed the properties of tau, usually an important part of the skeletal structure of cells, making it more likely […]
  • Researchers uncover crucial gene for growth of Ewing sarcoma October 23, 2020
    Researchers at the Institut de Recerca Sant Joan de Déu (IRSJD) in collaboration with those at Center for Genomic Regulation (CRG) have discovered that RING1B is a critical gene for the development of Ewing sarcoma, a rare type of developmental cancer that presents in bones and soft tissues. This newly uncovered epigenetic vulnerability in Ewing […]
Top