Invokana Renal Failure, Kidney Problems Should Have Been Anticipated
Our lawyers at Saiontz & Kirk, P.A. are continuing to review the potential for Invokana lawsuits on behalf of former users of the new diabetes drug who have suffered ketoacidosis, renal failure, kidney damage or other injuries.
Based on our research, it appears increasingly clear that Johnson & Johnson’s Janssen subsidiary knew or should have anticipated the risk of Invokana kidney problems based on the way the medication works, yet accurate renal failure warnings were not provided to consumers or the medical community.
Invokana was approved by the FDA in March 2013, as the first member of a new class of diabetes drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors.
Unlike other treatments for type 2 diabetes, these medications work by inhibiting the normal kidney functions in a way that allows the body to expel more sugar through the urine. However, as more and more individuals are prescribed the new drug, it appears that side effects of Invokana may be causing users to experience severe and potentially life-threatening renal impairment.
ISMP Report on Invokana Kidney Risks
Last month, the Institute of Safe Medication Practices (ISMP) provided a detailed review of Invokana in their QuarterWatch report (PDF), which independently evaluates adverse event reports submitted to the FDA by users of different prescription drugs.
During the first year Invokana was on the market, it was linked to a disturbing number of reported problems, surpassing 92% of the other drugs regularly monitored by the ISMP. Many of these adverse event reports involved kidney problems on Invokana, which the group correctly points out: “could have been reasonably anticipated, given the mechanism of action and pre-approval clinical trial data.”
Among 457 serious adverse event reports involving Invokana problems were reports of kidney failure, renal impairment, and kidney stones, as well as urinary tract infections, yeast infections and other problems. Both testing in animals and humans showed signs of a problem before the drug was released, according to the ISMP report.
“As might be expected from an agent that blocks a normal function of the kidney, evidence of renal impairment was seen in animal models. In repeat dose studies in rats, [Invokana] was associated with 10%-25% increased kidney weight and dilatation of the kidneys, pelvis and bladder. In human clinical trials, evidence of renal impairment was seen with a laboratory measure of kidney function, the estimated glomerular filtration rate (eGFR). At six weeks, eGFR was reduced 4-6%, compared to 2% in a placebo comparator group.”
The ISMP report raises serious questions about the risk of kidney problems with Invokana, suggesting that insufficient research and testing was done before the medication was approved. The group raised questions about whether the risks may exceed the potential benefits provided for individuals suffering from type 2 diabetes:
“The central unanswered question about [Invokana] — which extends in a different form to other diabetes medications — is whether the drug does more good than harm in long-term treatment. While Janssen noted that the drug had now been tested in more than 10,000 patients, the data were still of insufficient duration to establish whether the drug had a measurable clinical benefit on the complications of Type 2 diabetes. The current data are also insufficient to address unanswered questions raised in the FDA reviews about whether long-term use might result in a steady decline in kidney function, increased risk of bone fractures, or more cardiovascular events. By contrast, we observe clear evidence of harm to some patients in terms of hypersensitivity reactions and an array of renal adverse effects”
Lawsuits over Invokana renal failure or kidney failure are being evaluated to determine whether individuals may be entitled to financial compensation or settlements as a result of the drug maker’s failure to adequately research the side effects of this new diabetes drug or warn about the risk of severe and potentially life-threatening problems.
Potential cases are also being evaluated for potential Invokana ketoacidosis side effects, which may cause users to suffer health problems from a build up of acid in the blood, often resulting in hospitalization.
All claims are being handled by our lawyers on a contingency fee basis, which means that there are no attorney fees or expenses paid unless you are successful obtaining a recovery in the case.