Invokana Lawsuit Claims – Lawyers for Amputation Victims
Have You Suffered an Amputation After Taking Invokana?
The attorneys at our law firm are investigating cases of individuals suffering below the knee, foot, and toe amputations following the use of the Type 2 diabetes drug Invokana. These individuals may be eligible for significant financial compensation. Call now for a free case evaluation and to learn if you are entitled to redress for your injuries.
What is Invokana?
Invokana (canagliflozin) is a once-a-day medication used to lower blood sugar levels in diabetic patients. The medication belongs to a new generation of drugs known as SGLT2 inhibitors and is manufactured by drug maker Johnson & Johnson subsidiary Janssen Pharmaceuticals. Other SGLT2 inhibitor medications that have been approved by the FDA for the U.S. market include:
- Dapagliflozin – Brand name Farxiga, made by AstraZeneca
- Combination drug linagliptin and empagliflozin – brand name Glyxambi, made by Boehringer-Ingelheim
- Combination drug canagliflozin and metformin – brand name Invokamet, made by Janssen Pharmaceuticals
- Empagliflozin – brand name Jardiance, made by Boehringer Ingelheim
- Extended-release combination drug metformin and dapagliflozin – brand name Xigduo XR, made by AstraZeneca
SGLT2 is a sodium-glucose transporter that when blocked, allows the kidneys to excrete more glucose from the body to lower blood sugar levels. Invokana was approved by the FDA in March 2013, and similar drugs followed, each designed to block the SGLT2 transporter. Unfortunately, some patients who have been treated with Invokana have had to have their legs feet, or toes amputated.
Invokana – Increased Amputation Risks
About four years after being approved for sale on the U.S. market, the United States Food and Drug Administration issued Safety Communications regarding two findings that shocked many who use Invokana. The FDA announced that the diabetes drug might actually increase the chances of amputation in diabetic patients.
In fact, research shows that patients who are being treated with the drug have a higher risk of suffering amputation of their lower extremities including:
- Toe amputations
- Mid-foot amputations
- Below the knee amputations
- Above the knee amputations
- Multiple amputations involving both limbs.
The FDA recommends that patients do not stop taking Invokana until they speak with their physician. However, it is also recommended that patients who are on the medication pay close attention to their lower extremities and seek medical help immediately if the following are noticed on the foot or lower legs:
- Ulcers or sores
- Areas that are painful or tender to the touch
Amputation Risks Higher in Patients on Invokana
In the May 2017 FDA Safety Communication, the agency discussed the outcomes of two large clinical trials that showed evidence of heightened risks for foot and leg amputations for patients who take the drug Invokana. The results of these two studies prompted the FDA to require a Black Box Warning on all Invokana labels, warning the medical community and their patients about these risks. This type of warning is the government watchdog agency’s most severe label requirement.
Researchers in the first clinical trial determined the rate of occurrence of amputation for Invokana patients. They reported that 5.9 out of 1,000 patients being treated with the drug suffered amputations while only 2.9 per 1,000 patients receiving placebo suffered amputations.
The second clinical trial found a higher rate of amputation among patients being treated with Invokana over a 12-month period. The results of this study found that 7.5 of 1,000 patients receiving Invokana suffered amputations while only 4.2 of 1,000 patients receiving placebo had to have an amputation.
Diabetic patients must pay close attention to their feet and toes because of the effects of diabetes. While Invokana was supposed to help diabetics live healthier lives, researchers discovered that the medication might instead increase the risk of foot, toe and leg amputations.
But the FDA warning for amputations is only one of many that have been issued over the potential side effects of the drug. Patients who have been treated with Invokana and suffered some of these adverse events and side effects want to know why they weren’t warned of these dangers before their treatment started. These patients are seeking justice and answers and we can help.
New Studies Show SGLT-2 Makers Feel the Heat
More than 1,000 federally-filed lawsuits are pending in multidistrict litigation in U.S. District Court, District of New Jersey to be heard by U.S. District Judge Brian R. Martinotti (MDL-2750). Hundreds more cases have been filed in state courts across the country. These lawsuits allege that the drug maker failed to warn them of the risks of amputation and other injuries, including kidney damage, a dangerous condition called ketoacidosis, and bone fractures.
As the drug makers feel increasing pressure against a volley of accusations, they are funding studies that say the drug is safe. Take, for instance, a study published in March 2018 in the Journal of the American College of Cardiology. This was a large, multinational study of patients from North America, the Middle East, and Asia-Pacific. While the study focused on the benefits of the drug, there were limitations that make one question the results.
These limitations of the study include:
- safety data was excluded
- while the study included analyzing other glucose-lowering drugs, those drugs were never named,
- data used for the study was not independently verified,
- as an observational study, the outcome could have been influenced by other factors.
But what should give readers the most pause is that study was funded by the companies that manufacture, market, and sell SGLT-2 inhibitor drugs.
Another study touted as the most definitive study to date that documents the safety and efficacy of SGLT2 drugs, found that these medications do not pose an increased risk of amputations. And much like the other study, it was paid for by Invokana maker Janssen. Unless you read it closely, you might miss that the study only involved patients new to Invokana and other SGLT2 drugs who had been treated for six months or less.
But Type 2 diabetes requires life-long treatment, not six months of treatment, and earlier clinical trials showed the risk of amputation emerged after six to 12 months of exposure, while this study only looked at patients who had been on the drug for six months or less.
Other Invokana Injuries
By June 2014, at least 20 reports of ketoacidosis requiring emergency treatment including hospitalization were filed. Since that time, reports of adverse events continue to mount, including ketoacidosis, renal failure, and acute myocardial infarction.
By the second quarter of 2015, more than 1.1 million prescriptions were dispensed for Invokana, and as use of the drug grew, more than 5484 adverse events were reported. Of those events, at least 168 reports of ketoacidosis are being investigated.
In December 2015, after identifying 73 cases of ketoacidosis, the FDA issued an updated announcement that Invokana and other SGLT2 inhibitors must add a label warning consumers and physicians about the higher risk of ketoacidosis.
Aside from the higher risk of ketoacidosis, another frequent Invokana side effect is genital fungal infections. So far, the FDA has received reports of thousands of cases of genital fungal infections, which according to the agency, can spread to the kidneys presenting a potential deadly situation. In fact, clinical trials show evidence of a 3 to 4- fold risk of this type of dangerous infection.
In the December 2015 FDA announcement, the agency warned consumers that 19 cases of Invokana urinary tract infections had progressed to potentially fatal renal injury and blood infections requiring hospitalization and that some patients even required dialysis or intensive care for renal failure.
Invokana also increases the chances of fracture and decreases bone density. Fractures can occur within three months of beginning the medication and bones can break with even minor trauma, such as simply tripping or falling from a standing position.
An FDA ordered clinical trial found that Invokana causes bone mineral density loss at the hip and lower spine, making this drug even more dangerous to the elderly and those who already struggle with bone density issues. In September 2015, the FDA added a new Warning and Precaution to the adverse reactions section of the drug’s label to include the findings of that clinical trial and the higher risk of broken bones to those who use the medication.
Patients who depend on medications to treat their diabetes have had enough. They are filing lawsuits saying they took Invokana and experienced lower extremity amputations, spontaneous ketoacidosis, kidney damage, and broken bones. These Invokana Invokamet lawsuits claim that the manufacturer Janssen Pharmaceuticals, a division of pharmaceutical giant Johnson & Johnson, knew or should have known about the dangers associated with the new-generation drug Invokana, and failed to warn consumers and their physicians about those dangers.
Lawsuits have already been filed in Canada, Europe and across the U.S. against the makers of Invokana alleging that after only a relatively short time on Invokana, patients lost feet, toes, and legs, and may begin to develop symptoms of a life-threatening condition called ketoacidosis, which occurs when acids begin to build up in the blood.
Invokana amputation lawsuits are pending in the U.S. and other countries alleging that Invokana causes an increased risk of foot and leg amputations. In fact, the increased risk is so severe the FDA required the drug maker to add a Black Box Warning to the label.
Mass tort litigation involving diabetes drug Invokana continues to mount. While thousands of cases have been filed across the country over injuries, cv events, renal damage, and amputations, no high-level court has approved a class action. Currently, hundreds of Invokana lawsuits filed in federal courts have been consolidated in multi-district litigation in U.S. District Court District New Jersey. Cases pending in the MDL are different from any filed in a class action lawsuit in that any damages awarded go to the plaintiff and are not shared among class members.
Patients who have already filed Invokana lawsuits say that they would not have consumed Invokana if they were aware of the drugs dangerous side effects. The patients claim that Janssen was negligent by not telling medical professionals and their patients about the heightened risks of suffering toe, foot, and leg amputations.
Our attorneys are working with patients who have been harmed by Invokana. These patients may be able to take legal action to hold Janssen and Johnson & Johnson responsible for the medication and its potentially dangerous side effects. These types of injuries may entitle patients to financial compensation and damages for their injuries.
If you or a family member suffered toe, foot, or leg amputations while taking Invokana, contact one of our attorneys now. For decades we have fought for the rights of patients harmed by the medications they depend on, and we will fight for you now. Contact us today to learn more about patient rights, dangerous medications, and whether you are entitled to seek significant compensation for your Invokana injuries.