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New Study Highlights Ketoacidosis Risk for Invokana Patients

PillsKnown as a sodium-glucose cotransporter-2, the blockbuster diabetes drug Invokana has been flying off the shelves, launching it to the top of the class of drugs also including Farxiga, Jardiance, Xigduo XR and Glyxambi. The drug presents a new and innovative way to treat the presence of glucose in the bloodstream, and allows Type 2 diabetes sufferers to benefit from more efficient renal glucose reabsorption. More specifically, drugs like Invokana work to increase glucose and energy loss through the urine, thereby reducing the toll of hyperglycemia on the patient’s other organ systems.

While Invokana has been highly-touted as a safe and effective treatment for diabetes – as well as aggressively marketed across virtually every medium imaginable – researchers at the Peking University have cautioned that the drug may cause significant, unexpected side effects in patients – and those taking the drug should be regularly monitored to avoid catastrophic results.

Potential Invokana risks

In a study of 4,670 participants across six clinical trials, Invokana researchers concluded that while the drug may be a safe and effective “add on” to other frontline diabetes treatment drugs, it is not without significant risk. According to the study published in the Journal of Diabetes Investigation, Invokana may place patients at risk of the development of certain life-threatening medical conditions, including ketoacidosis, hypoglycemia and acceleration of diabetes-associated sarcopenia.

Less-serious medical conditions also emerged during the study, including chronic urinary-tract infections, genital tract infections and “adverse events-related osmotic diuresis.”

FDA & expert concerns about Invokana

The FDA has issued several safety communications with regard to sodium-glucose cotransporter-2 drugs, beginning with the announcement concerning the possible link between these drugs and the onset of ketoacidosis. This condition, which could ultimately lead to death if left untreated, causes a dangerous build-up of acidity in the blood stream, ultimately wreaking havoc on organ systems and placing patients in grave danger of permanent damage.

Around the same time, these drugs were also named by the Institute of Safe Medication Practices (ISMP) as a potential cause for deadly kidney toxicity, as the drugs alter the functionality of the kidneys when transporting waste from the blood stream. In their report, the ISMP highlighted over 450 reported cases of kidney malfunction in patients prescribed Invokana, including “kidney failure, kidney impairment or problems with kidney stones, urinary tract infections, dehydration, hypersensitivity and abnormal weight loss.”

Moreover, the study revealed that patients taking Invokana reported adverse events at a rate 92 percent higher than those reported by patients taking other drugs also monitored by the group.

Renal issues aside, Invokana may also cause severe bone brittleness, resulting in fractures and broken bones where a non-user would likely not experience such a significant injury. For instance, the FDA reports the existence of compelling evidence that Invokana patients may experience total bone breakage following minor falls from no higher than a standing height.

As concerns mount, a growing number of Invokana lawsuits have emerged across the United States – most of which allege the negligent failure to warn patients as to the dangers of the drug, as well as various other causes of action against the drug makers.

  1. NCBI.NLM.NIH.gov, Sodium-glucose co-transporter-2 inhibitors: an emerging new class of oral antidiabetic drug, http://www.ncbi.nlm.nih.gov/pubmed/19125776
  2. Onlinelibrary.wiley.com, Efficacy of canagliflozin combined with antidiabetic drugs in treating type 2 diabetes mellitus: Meta-analysis of randomized control trials, http://onlinelibrary.wiley.com/doi/10.1111/jdi.12417/pdf