Have You Suffered an Amputation, Ketoacidosis or Kidney Failure After Taking Invokana?
Table of Contents
- 1 Have You Suffered an Amputation, Ketoacidosis or Kidney Failure After Taking Invokana?
- 1.1 What is Invokana?
- 1.2 Invokana – Increased Amputation Risks
- 1.3 Amputation Risks Higher in Patients on Invokana
- 1.4 Invokana Study Results
- 1.5 SGLT2 Inhibitors like Invokana Associated with Diabetic Ketoacidosis and Renal Injury
- 1.6 *1 in 1,000 Invokana patients could be affected by ketoacidosis – more than 1.1 million prescriptions dispensed
- 1.7 Symptoms of Ketoacidosis may include:
- 1.8 Invokana Kidney Failure
- 1.9 Invokana Bone Fractures
- 1.10 Invokana Lawsuits
The attorneys at our law firm are investigating cases of individuals suffering amputations, broken bones, acute myocardial infarction, stroke, kidney damage, renal failure, and diabetic ketoacidosis following the use of the Type 2 diabetes drug Invokana. These individuals may be eligible for financial compensation. Call now for a free case evaluation.
What is Invokana?
Invokana (canagliflozin) is a once-a-day medication used to lower blood sugar levels for diabetics. 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
- 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 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 may 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 patient take 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 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 Renal Injury
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.
*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 being treated with 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 that have been filed on behalf of Invokana users allege that the J&J knew or should have known about the serious side effects of Invokana before releasing it to the market. The Invokana lawsuits also allege that J&J and its subsidiary Janssen failed to warn physicians and their patients about the serious, potentially deadly side effects of the drug.
Invokana Kidney Failure
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.
The FDA recommends that anyone who experiences the following signs and symptoms of a UTI while being treated with Invokana seeks 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 knew or should have known about the higher risks of genital fungal infections, blood infections, and renal 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 renal damage or blood infections, or if you suffered renal failure while taking Invokana, call us today for a free case evaluation.
Invokana Bone Fractures
Invokana 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.
Contact your physician and tell them you are taking Invokana if you experience any of the following symptoms –
- Fractures and breaks
- Decreased bone density
- Kidney injury
- High potassium levels
- Increased cholesterol
- Yeast infections
We are currently investigating claims that patients have suffered broken bones, acute myocardial infarction, ketoacidosis, and renal failure while taking Invokana for their Type 2 diabetes. If you or a loved one has suffered a fractured or broken bone while on this SGLT2 inhibitor, contact us today. We believe that J&J 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 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 may begin to develop symptoms of a life-threatening condition called ketoacidosis, which occurs when acids begin to build up in the blood.
Invokana Lawsuits are pending in the U.S. and other countries alleging that Invokana can cause serious renal damage, including renal failure. In fact, at least 19 patients were involved in reports received by the FDA shortly after Invokana hit the market, and all 19 patients were hospitalized with UTIs that lead to blood infections and kidney infections, some requiring intensive care and dialysis for renal failure.
Mass tort litigation involving diabetes drug Invokana continues to mount. While thousands of cases have been filed across the country over injuries, cv event, 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.
We are currently working to help Invokana patients who have experienced ketoacidosis or renal failure while taking Invokana or shortly after stopping Invokana. Some of these patients developed serious and potentially deadly 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 injury, coma, and even wrongful death.
Patients who have already filed Invokana lawsuits say that they would not have consumed 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 heightened risks of developing ketoacidosis and renal 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 fatal side effects. These types of injuries may entitle patients to financial compensation and damages for their injuries.
If you have experienced renal failure, heart attack, or diabetic ketoacidosis while taking Invokana, contact one of our attorneys now for a free case evaluation to learn if you are eligible for financial compensation.