The FDA approval of Invokana, a newly-developed drug for type 2 diabetes, was announced with great fanfare in 2013. Unlike other blood sugar-lowering medications on the U.S. market, Invokana was formulated to act independently of insulin, and the medical community was awash with hope that the drug would open up improved possibilities for diabetes management.
Janssen Pharmaceuticals, the subsidiary of Johnson & Johnson that manufactures Invokana, spent millions of dollars on print ads, television commercials, and promotional speakers, eager to appeal to a market hungry for new methods of blood sugar control. This aggressive advertising certainly paid off—an estimated 4 million Americans are prescribed Invokana every year.
But only 2 years after the drug was brought to market, the FDA issued a safety alert urging patients taking Invokana or related drugs to watch for signs for ketoacidosis, a form of blood poisoning that can become severe enough to require hospitalization. In fact, Invokana has been under close scrutiny by the FDA even before its approval, and possible evidence pointing to unexpected side effects—some of which can prove fatal— continues to surface.
Second FDA Alert Warns Of Possible Bone Problems
On September 10, 2015, about 5 months after the ketoacidosis warning was released to the public, the FDA sent out another Invokana alert. This time, the agency wrote of 2 concerns regarding bone health in Invokana users:
- Heightened Bone Fracture Risk. In several clinical trials, an increased risk of bone fractures was seen in Invokana patients as early as 12 weeks after starting their prescriptions. Worse yet, the fractures suffered by the patients in the trials were not always preceded by a trauma event, and when they were, the trauma was relatively minor, such as a fall from standing height or less.
- Bone Density Loss. In a study that the FDA had previously ordered Janssen Pharmaceuticals to perform, over 700 elderly patients on Invokana were monitored over a period of 2 years and found to have decreased bone mineral density, an indicator of bone strength, in comparison to patients taking a placebo. Even more troubling, this loss of bone density was particularly apparent in the hip bones and the lower spine—areas vital to overall stability.
Invokana’s Prescribing Information already included warnings about bone fractures, but the FDA instructed the manufacturer to add more information and stronger warnings, as well as a whole new section informing consumers about the possible bone mineral density loss.
FDA Committee Concerned Over Cardiovascular Side Effects
Disturbingly, the side effects that were announced by the FDA were neither the first nor the most serious unexpected potential problems surrounding Invokana.
Half of the drug’s approval committee, a panel of medical experts from the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC), found the matter of Invokana’s cardiovascular safety a cause for concern.
Patients Experience Heart Attack And Stroke With Invokana Use
In one of the early clinical trials that had the committee ill at ease, patients taking Invokana were found to exhibit an increased risk of “thrombotic events”—namely, serious blood clots, heart attack, and stroke—compared to patients taking a placebo. These cardiovascular problems occurred mainly within the first 30 days of starting a prescription.
After these results were presented on January 10, 2013, when the FDA held a meeting for the EMDAC to decide whether or not to approve Invokana (the transcript can be read here), 8 out of 15 committee members reported having “lingering concerns” about the drug’s potential cardiovascular impacts.
Other members of the medical community who were present at the meeting also found the clinical data unsettling. For example, Dr. Sidney Wolfe, founder of Health Research Group, called these cardiovascular risks a “significant problem,” and speculated that Invokana’s marked diuretic effect could be the root of such risks. Increased urination can severely lower fluid levels, throwing off the body’s blood-cell-to-fluid ratio and creating thickened blood that tends to clot and cause other complications.
Despite Doubts, Invokana Is Approved And Sold Without Cardiovascular Warnings
Though the panel ended up approving Invokana, 5 panel members still felt that the drug was not fit to be sold on the market, at least not without further testing. Even many who had voted in favor of approval expressed dissatisfaction with the short duration periods of the studies performed by the manufacturer, saying that they would feel more confident in the drug’s safety if more long-term results were available. In response to these concerns, the FDA required Janssen Pharmaceuticals to conduct 5 extensive post-marketing trials, including one focused on cardiovascular issues.
Shockingly, though the “early risk signal” of cardiovascular events was such a crucial concern during the approval meeting, Janssen Pharmaceuticals chose to exclude any mention of it on Invokana’s Prescribing Information. The manufacturer dismissed the early clinical data as potentially “insignificant,” in part because the increased risks were observed to fade after 30 days.
Yet, as many consumer advocates point out, even if the risks are low or short-lived, it’s important for doctors to be fully aware of them in order to write safe prescriptions, especially for patients who may have existing cardiovascular problems. Plus, tragedy can strike even within a short time period—just one heart attack or stroke could be enough to damage a patient’s health permanently, or even cause death.
Can Invokana Cause Kidney Damage?
Invokana’s active ingredient, cangliflozin, is an “SGLT2 inhibitor”—a compound that blocks the retrieval of glucose from filtered waste, one of the kidneys’ main functions. In light of this, it’s not surprising that possible kidney damage was another issue that the approval committee showed concern over.
3 of the 5 committee members who had voted against releasing Invokana stated that the drug’s potential adverse effects on the kidneys was the main reason for their “no” vote. One of these members, Dr. Peter Savage, elaborated by commenting that he wasn’t convinced “
[Invokana] wouldn’t…actually damage the kidneys with long-term urinary tract infections and so forth.”
High Ratio Of Kidney Ailments Found In FDA Patient Reports
And now that Invokana is on the market, complaints from consumers lend further evidence that the drug may have a negative impact on kidney function.
The Institute for Safe Medication Practices (ISMP), a nonprofit consumer group, performed an extensive analysis of 457 Invokana patient reports to the FDA, all submitted in a single quarter (April-May 2014). A high prevalence of “serious injuries involving kidney function” was uncovered in the analysis, which the ISMP organized into 5 categories of adverse effects “directly or indirectly related to the renal toxicity of canagliflozin”:
- Kidney impairment, including kidney failure (54 reports)
- Fluid imbalances or dehydration (54 reports)
- Urinary traction infection (50 reports)
- Kidney stones (11 reports)
- Weight loss from unidentified causes (52 reports)
While discussing these findings, the ISMP also delved into an unsettling series of early clinical trials in which patients suffered from kidney impairment within 6 weeks of starting Invokana treatment. Kidney function was evaluated by testing for a reduction in “eGFR” (estimated glomerular filtration rate), a common diagnostic for kidney disease. In comparison to a placebo group that experienced a 2% decrease in eGFR, a statistically significant 4-6% decrease was seen in the Invokana patients. Also, 4% of patients who were given high dose pills (Invokana is offered in 100 mg or 300 mg doses) were stricken with an eGFR decline of 30% or greater.
Health Canada Finds A Link Between Invokana and “Acute Kidney Injury”
The ISMP isn’t the only organization concerned about Invokana’s potential effect on the kidneys. On October 16, 2015, Health Canada announced that it just conducted a major safety review of Invokana and the related drug Forxiga (marketed as “Farxiga” in the U.S.) to evaluate the likelihood of the drugs causing “acute kidney injury.”
The agency reviewed both patient reports and medical research literature, ultimately deciding that “the evidence supported the existence of a link between the use of SGLT2 inhibitors and the risk of acute kidney injury.” The safety review announcement concluded by stating that Health Canada continues to monitor SGLT2 inhibitors for “any new health risks,” and will require Invokana’s manufacturer to update the drug’s Canadian labeling to include mention of kidney impairment / damage.
Canadian Patients Are Filing Invokana Kidney Damage Lawsuits
In anticipation of a wave of kidney-related claims, Rosalba Joudry, a resident of Ontario, Canada, is requesting class action status for her case, which is the first officially-filed Invokana lawsuit to date. Joudry alleges in her suit that after only 8 months of taking Invokana, the drug caused her kidneys to fail.
At the same time, because Invokana’s label currently doesn’t include kidney impairment warnings (only a note stating that individuals with existing kidney problems should avoid the drug), and because kidney damage can occur with few or no symptoms, Joudry claims she was unaware of Invokana’s effect on her kidneys until her doctor ran tests and found that her kidneys were already failing.
Kidney damage reduces the effectiveness of the kidneys in removing bodily toxins, and kidney failure can necessitate a kidney transplant, a lifelong need for dialysis treatments, or even lead to death if waste is allowed to build up unchecked. In light of this, it’s not surprising that Joudry and other patients who have yet to file are seeking justice against Invokana’s manufacturer for alleged negligence.
Have You Been Harmed?
If Invokana may have had a negative impact on your health or that of someone you love, contact the personal injury attorneys at Banville Law today for a free case evaluation. You may be entitled to significant compensation for your suffering, and our experienced attorneys can help you achieve justice through an Invokana lawsuit.
There’s no need to worry about potential costs—we will serve you on a contingency fee basis, which means our legal team only accepts pay after you’re granted a court award or settlement for your case.