In 2013, the FDA approved a new diabetic drug called Invokana. Invokana was a new type of drug, specifically for use in those with Type 2 diabetes. The drug could be used in conjunction with other diabetic drugs, such as Metformin, or as a stand-alone drug. Invokana is generally taken in pill form, once daily. Because Invokana works as a diuretic, a significant number of those taking the drug have dizziness.
Symptoms of low blood sugar such as headache, weakness, drowsiness, confusion, irritability, hunger, shaking or jittery feelings, rapid heartbeat and sweating have also occurred in some patients. Unfortunately, in the years since Invokana received FDA approval, many more serious side effects have come to light, including Invokana kidney disease, Invokana amputation and Invokana ketoacidosis. Those who have suffered such serious side effects after taking Invokana should strongly consider contacting an experienced Invokana injury lawyer as soon as possible.
How Invokana Works for Type 2 Diabetics
Invokana works by inhibiting sodium glucose co-transporter 2 (SGLT2) inhibitor, which is a carrier aiding in the reabsorption of glucose into the bloodstream through the kidneys. Invokana essentially flushes the surplus glucose from the body—which also makes it a powerful diuretic. SGLT-1 and SGLT-2 attempt to inhibit sugar loss in the body by transporting glucose from the kidneys back into the body. SGLT-2 re-absorbs about 9/10ths of glucose while SGLT-1 re-absorbs the remaining glucose in the kidneys.
Invokana blocks this mechanism, preventing the re-absorption of glucose. Studies showed that Invokana worked more effectively than glimepiride (which increased insulin production in the pancreas) and has the same level of efficacy as sitagliptin (Januvia) which inhibits enzymes and increases pancreatic function. Unfortunately, incretin therapy drugs such as Januvia, Victoza and Byetta have been as embattled as Invokana, facing mass litigation due to the risks of users developing pancreatic cancer.
Other SGLT-2 inhibitors which have come onto the market since Invokana include Farxiga, Glyxambi, Jardiance and XigduoXR. These drugs have also had many problems and are responsible for injuries to consumers. In fact, Farxiga has been linked to diabetic ketoacidosis, heart attack, bone fractures and kidney failure, and Glyxambi has been linked to serious diabetic ketoacidosis. The litigation for Farxiga and Xiduo XR has been centralized in New York for pretrial handling. Anyone who has suffered Invokana ketoacidosis, Invokana kidney failure or Invokana amputation—as well as anyone who has suffered similar harm from other SGLT-2 inhibitor drugs—should speak to a knowledgeable Invokana injury lawyer.
Is Invokana Similar to the Rejected Diabetes Drug Forxiga?
After rejecting the diabetic drug Farxiga in 2012, the FDA approved the drug early in 2014. Farxiga works in a similar manner as Invokana, in that it is a sodium glucose co-transporter 2 inhibitor which blocks the reabsorption of glucose by the kidneys. At the July 2012 meeting of the FDA, the advisory committee recommended against approving Farxiga by a 9-6 vote, citing concerns over potential breast and bladder cancer risks.
A hepatologist present at this meeting called Farxiga “brilliant in its simplicity.” Even so, the drug appeared to raise the risk of breast and bladder cancers among the patients in the eleven phase III clinical trials conducted by manufacturers, Bristol-Myers Squibb and AstraZeneca. Among 5,478 patients taking Farxiga in the clinical trials, nine developed bladder cancer compared with one patient developing bladder cancer in the control group.
Among women taking Farxiga during the clinical trials, nine out of 2,223 women developed breast cancer with only one women developing breast cancer in the control group. One reviewer for the FDA estimated women taking Farxiga had a fourfold increase in the development of breast cancer and male diabetics had five times the risk of developing bladder cancer when taking Farxiga. In 2012, the FDA sent Farxiga manufacturers back to the drawing board, then a year later approved Invokana.
In early 2014, AstraZeneca and Bristol-Myers Squibb re-applied for approval for Farxiga; the drug received approval from the FDA by a 13-1 vote and a 10-4 vote stating the drug had an acceptable cardiovascular risk profile. The eventual approval of Farxiga did come with strings: the manufacturers of the drug was ordered to conduct six post-market studies, including the cardiovascular outcomes in patients with cardiovascular risks, a bladder cancer risk trial, two trials on risks to pediatric patients, an animal study which looks at drug-induced urinary flow and the promotion of bladder tumors and a trial which studies liver abnormalities and pregnancy outcomes.
Invokana received FDA approval with the stipulation that five additional post-marketing studies be completed. These studies include:
· A trial which studied cardiovascular outcomes among those taking Invokana
· A program which monitors malignancies, serious pancreatitis disorders, severe hypersensitivity reactions, liver abnormalities and adverse pregnancy outcomes among those taking Invokana.
· A study on bone safety for patients taking Invokana
· Two pediatric studies which report the safety and efficacy of Invokana for pediatric patients.
Potential Risks of Invokana Kidney Failure
A full third of the FDA panel who reviewed the research provided by Johnson & Johnson expressed concern regarding Invokana kidney failure; many people with Type 2 diabetes have some level of kidney disease, and the fear was that Invokana could potentially worsen kidney disorders. The manufacturer did include cautions on Invokana labeling which stated that “Invokana increases serum creatinine and decreases eGFR (glomerular filtration rate).”
Older people, particularly those over 75 are the most likely to have severe kidney-based reactions to Invokana. A New Jersey woman is claiming she developed an acute kidney injury which led to kidney failure, less than two months after she began taking Invokana. Plaintiff Jessica Calongne has asserted her injuries were entirely preventable, and were caused by a lack of thorough testing for Invokana and a failure to warn patients and doctors about the potential kidney risks associated with the drug.
Additional Dangers Associated with Invokana
Aside from kidney failure, other adverse health issues such as dangerous ketoacidosis is possible for those taking Invokana. In June 2016, a Phase II study done on Type 2 diabetes patients found Invokana increased the rate of serious adverse events related to diabetic ketoacidosis. In May 2017, the FDA required Janssen and Johnson & Johnson to add a black box warning regarding an increase in leg and foot amputations among those taking Invokana.
Healthcare professionals were advised at that time to carefully follow all drug labeling recommendations for their patients taking Invokana, and to keep close watch for any new pain or tenderness, ulcers, sores or infections in the legs or feet. Invokana was also linked to an increase in heart attacks and strokes, during the first 30 days of treatment. In the post-marketing clinical trials, these two risk factors “suddenly and inexplicably” leveled out. It is a well-documented fact that Invokana can increase cholesterol levels, which could, in turn, cause cardiovascular issues.
How a Sullo & Sullo Invokana Injury Lawyer Can Help
At this time, Invokana has not been recalled in the United States, however the investigations into the potential health risks of the drug is ongoing. As more and more complaints are filed against Janssen and J & J regarding harm suffered by Invokana, a settlement could be possible. All Invokana lawsuits are bound by state-imposed statutes of limitations, meaning there is a limited time in which to file your product liability claim.
Some of the current claims made in the Invokana lawsuits include misrepresentation of the drug’s benefits and risks, manufacture of a defective drug, negligence and failure to warn of risks. If you or a loved one has been harmed by Invokana—whether from Invokana kidney damage, Invokana amputations, Invokana ketoacidosis or other injuries associated with the drug—an experienced Sullo & Sullo Invokana injury lawyer can help you make the best decisions for your future.