Invokana Amputation Lawyer for Lawsuit Claims
Have You Suffered an Amputation, Ketoacidosis or Kidney Failure After Taking Invokana?
Our attorneys are investigating cases of individuals suffering amputations, bone fractures, heart attack, stroke, kidney failure and diabetic ketoacidosis following the use of this Type 2 diabetes drug. These individuals may be eligible for financial compensation.
What is Invokana?
Invokana (canagliflozin) is a once-a-day medication used to lower blood sugar for type 2 diabetics. The medication belongs to a new generation class of drugs known as SGLT2 inhibitors and is manufactured by Johnson & Johnson subsidiary Janssen Pharmaceuticals. Other SGLT2 medications that have been approved by the FDA for the U.S. market include:
- Dapagliflozin – Brand name Farxiga
- Combination drug linagliptin and empagliflozin – brand name Glyxambi
- Combination drug canagliflozin and metformin – brand name Invokamet
- Empagliflozin – brand name Jardiance
- Extended release combination drug metformin and dapagliflozin – brand name Xigduo XR
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.
Invokana – Increased Amputation Risks
About four years after being approved for sale on the U.S. market, the U.S. Food and Drug Administration issued Safety Communications regarding two findings that shocked many diabetic patients. The FDA announced that the drug may actually increase the risk 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 Increased 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 increased risks for foot and leg amputations for patients being treated with 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. The Black Box warning is the government agency’s most severe label requirement.
Invokana Study Results
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 may 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.
SGLT2 Inhibitors like Invokana Associated with Diabetic Ketoacidosis and Kidney Failure
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 diabetic ketoacidosis, kidney failure, and heart attack.
By the second quarter of 2015, more than 1.1 million prescriptions were dispensed for Invokana, and as use of the drug increased, more than 5484 adverse events were reported. Of those events, at least 168 reports of diabetic 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 increased risk of ketoacidosis.
*1 in 1,000 Invokana patients could be affected by ketoacidosis – more than 1.1 million prescriptions dispensed
The European Medicines Agency (EMA) issued an announcement that the global database EudraVigilance recorded over 100 incidents of ketoacidosis in patients being treated for diabetes. In certain instances, the EMA warned that patients who are suffering from ketoacidosis may not present with blood sugar levels as high as would normally be expected, causing treatment to be delayed. The EMA estimates that 1 in 1,000 Invokana patients may be affected by ketoacidosis.
The FDA is requiring that Invokana and other SGLT2 makers conduct studies analyzing spontaneous ketoacidosis for five years.
Symptoms of Ketoacidosis may include:
- Stomach and abdominal pain
- Fatigue and malaise, or unusual tiredness
- Difficulty breathing or shortness of breath
- Rapid weight loss
- Excessive thirst
- Fast and deep breathing
- A metallic or sweet taste in the mouth or on the breath
- A change in body odor or sweat
If you are taking Invokana or another SGLT2 inhibitor and you experience any of these symptoms, seek medical attention right away, and inform the physician that you are taking an SGLT2 inhibitor.
Lawsuits filed on behalf of Invokana users will allege that the Johnson & Johnson knew or should have known about the serious side effects of Invokana before releasing it to the market. The lawsuits will also allege that J&J and its subsidiary Janssen Pharmaceuticals failed to warn physicians and their patients about the serious, potentially deadly side effects of the drug.
Invokana Kidney Failure
Aside from the increased 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 life-threatening 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 life-threatening kidney and blood infections requiring hospitalization and that some patients even required dialysis or intensive care for kidney failure.
The FDA recommends that anyone who experiences the following signs and symptoms of a urinary tract infection while taking Invokana, seek medical advice as soon as possible. –
- Burning sensation when urinating
- Feeling or urgency to urinate
- Pain in the pelvis or lower abdominal area
- Bloody urine
Our attorneys believe that Invokana maker Janssen Pharmaceuticals knew or should have known about the increased risks of genital fungal infections, blood infections, and kidney failure. We allege that Janssen should have warned consumers and their physicians about the dangerous side effects of this drug.
If you have suffered serious kidney or blood infections, or if you suffered kidney failure while taking Invokana, call us today. You may be eligible for financial compensation.
Invokana Bone Fractures
Invokana linked to decreased bone density and bone fractures.
Invokana increases risk 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 increased risk of bone fractures to those who use the medication.
Contact your physician and tell them you are taking Invokana if you experience any of the following symptoms –
- Bone fractures
- Decreased bone density
- Kidney problems
- High potassium levels
- Increased cholesterol
- Yeast infections
We are currently investigating claims that patients have suffered bone fractures, heart attack, diabetic ketoacidosis, and kidney failure while taking Invokana for their Type 2 diabetes. If you or a loved one has suffered a bone fracture while on this SGLT2 inhibitor, contact us today. We believe that Johnson & Johnson and Janssen Pharmaceuticals knew the dangerous side effects of Invokana and failed to warn consumers and medical professionals about these dangers.
Lawsuits are being filed on behalf of patients who took Invokana and experienced spontaneous diabetic ketoacidosis, kidney failure, and broken bones. These lawsuits claim that Invokana manufacturer Janssen Pharmaceuticals, a division of pharmaceutical giant Johnson & Johnson, knew or should have known about the dangers associated with the new-generation diabetes drug Invokana, and failed to warn consumers and their physicians about those dangers.
Lawsuits have already been filed in Canada, Europe and across the United States against the makers of Invokana alleging that after only a relatively short time on Invokana, patients may begin to develop symptoms of a life-threatening condition called ketoacidosis, which occurs when acids begin to build up in the blood.
Lawsuits are also being filed in the U.S. and other countries alleging that Invokana can cause serious kidney problems, including kidney failure. In fact, at least 19 patients were involved in adverse event reports received by the FDA shortly after Invokana hit the market, and all 19 patients were hospitalized with urinary tract infections that lead to blood infections and kidney infections, some requiring intensive care and dialysis for kidney failure.
We are currently working to help Invokana patients who have experienced diabetic ketoacidosis or kidney failure while taking Invokana or shortly after stopping Invokana. Some of these patients developed serious and potentially life-threatening conditions after only a few months on Invokana. Ketoacidosis can occur quickly and if medical intervention is not obtained, the dangerous condition can cause a patient to suffer coma and even wrongful death.
Patients who have already filed lawsuits say that they would not have taken Invokana if they were aware of the drugs deadly side effects. The patients claim that Janssen was negligent by not telling medical professionals and their patients about the increased risks of developing ketoacidosis and kidney failure.
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 life-threatening side effects. These patients may be eligible for financial compensation and damages for their injuries.
If you have experienced kidney failure, heart attack, or diabetic ketoacidosis while taking the SGLT2 inhibitor Invokana, contact one of our attorneys now.