Much of the attention Invokana garnered during its FDA process was due to its mechanism of action. It is the first of the sodium-glucose cotransporter 2 (SGLT2) inhibitor class of drugs introduced to the American public. Invokana blocks glucose from being reabsorbed into the blood; essentially attacking blood sugar at the beginning of the cycle. Traditional diabetic drugs have acted once the blood sugar has been absorbed into the cells.
Serious concerns have plagued Invokana since its inception
When Invokana was first approved in 2013, the Food and Drug Administration (FDA) required its manufacturer, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), to conduct double-blind prospective placebo studies in order to evaluate the medication’s risks. Such studies are the “gold standard” in the pharmaceutical industry and are rarely required due to the associated costs and risks. However, concerns about Invokana’s suspected link to cardiac problems were serious enough to require these studies.
After a FDA-mandated clinical trial, CANVAS, it was discovered the use of Invokana was directly linked to an increase in the amputations of limbs. Halfway through those double-blind studies, evidence began to emerge that Invokana patients were at a significantly elevated risk of lower limb amputations, meaning the loss of a toe, foot, or leg either above or below the knee. The final results found leg and foot amputations occurred twice as often in those patients treated with Invokana compared to those treated with the standard diabetic protocol.
Most patients in the CANVAS trial suffered from infections, restriction of blood supply to legs or feet, or death of soft tissue due to loss of blood supply prior to the need for amputation. Toe and mid-foot amputations were documented the most; however, leg and above the knee amputations were also documented.
In addition, Invokana has been linked to diabetic ketoacidosis, a serious and potentially fatal condition, as well as kidney failure.
Black Box warning applied to Invokana
The U.S. Food and Drug Administration monitors studies and reports from adverse effects to determine the side effect warnings of pharmaceutical drugs and medical devices. The totality of the information is examined for public safety and potential warnings. The most serious of these label warnings is called a “black box warning”. It is designed to bring attention to the most important risks associated with the use of a drug.
In 2015, the FDA issued a diabetic ketoacidosis warning for Invokana and related drugs. Invokana was required to implement a Black Box warning in its labels in May of 2017 due to the link between Invokana and lower limb amputations. This warning is for both health professionals and patients for them to make informed decisions about treatment.
Negligence on the part of the manufacturer may have led to serious injuries
By 2016, Johnson & Johnson was well aware of the risk of amputation as the results of the double-blind studies became clear. However, the manufacturer did nothing at that time to warn patients and doctors of those risks.
More recently, Johnson & Johnson has seized upon study results indicating Invokana may provide some protection against cardiac problems. While those results may be legitimate, patients need to be fully aware of all risks associated with their medications so they can make informed decisions about their health. Lawsuits are already pending against Janssen and Johnson & Johnson due to the serious health risks associated with their product.
Contact an Invokana attorney today
If you or someone you know has been injured by Invokana, the attorneys of Tracey & Fox can help. Tracey & Fox attorneys have worked for years to hold drug manufacturers responsible for the injuries inflicted on uninformed patients. Call 866-622-4419 or contact us online today for a free consultation for a potential claim against the makers of Invokana.