Invokana – Kidney Damage
The FDA revised Invokana’s label to warn of acute kidney damage when taking canagliflozin. This is the active ingredient in Invokana.
Type 2 diabetes is a medical condition affecting over 9% of the population or an estimated 28 million Americans. The most common drug to treat Type 2 diabetes is Invokana.
Manufactured by Johnson & Johnson, Invokana is the brand name of the drug canagliflozin, which is a sodium glucose cotransporter-2 (SGLT2) inhibitor. This class of Type 2 diabetes drugs lowers blood sugar by causing the kidneys to remove sugar from the body via urine.
ISMP Invokana Kidney Damage Study
The Institute for Safe Medication Practices (ISMP) published an independent review of Invokana. The report reviewed adverse events submitted by Invokana users to the FDA. This report linked Invokana to a number of disturbing side effects. One of those involved kidney problems.
A total of 457 adverse event reports involved Invokana and either kidney failure, renal impairment, kidney stones along with other kidney infections. ISMP also uncovered that kidney damage was reported in clinical trials and animal testing before Invokana’s approval.
Johnson & Johnson should have anticipated the risk of Invokana kidney problems from the pre-approval trials, yet kidney damage warnings were not provided to consumers or the medical community.
Invokana Kidney Failure
Kidneys filter waste products from the bloodstream. They also maintain blood sugar, electrolyte levels, regulate fluid balance and blood pressure. When medications damage the kidneys, they can stop functioning. When the kidneys fail, a buildup of waste in the blood may occur. Dialysis is needed to reverse the effects of kidney failure.
From the time the FDA approved Invokana, they received 101 reports of acute kidney injury. Of these cases, 96 patients required hospitalization. Twenty-two required intensive care. Four patients died while hospitalized. In about 50 percent of these cases, acute kidney injury occurred within one month or less of starting the drug.
According to the FDA, 56 of these patients discontinued the medications and saw some improvement, but it warned that kidney injury is not reversible in all situations.
Invokana Kidney Failure Symptoms
Signs and symptoms of kidney failure may include:
- Decreased urine output
- Fluid retention which causes swelling in legs, ankles or feet
- Shortness of breath
- Seizures or coma in severe cases
- Chest pain or pressure
FDA Label Changes
The FDA revised labeling to warn of acute kidney injury when taking canagliflozin. This is the active ingredient in Invokana. Along with the label change, the FDA also advised doctors and health care professionals to consider risk factors that could predispose patients to acute kidney damage. These include low blood volume, congestive heart failure, and certain medications. The medications include diuretics, blood pressure medications known as angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and non-steroidal anti-inflammatory drugs (NSAIDs).
Many people with diabetes are prescribed these other medications. Patients are urged to seek immediate medical attention when displaying signs of severe kidney damage, which includes decreased urine and swelling of lower extremities.
Invokana Kidney Damage Litigation
According to the FDA, there were at least 20 cases of ketoacidosis associated with the class of SGLT2 inhibitors drug within 15 months. All these cases require visits to the emergency room or hospitalization.
But that’s nothing compared to 457 serious adverse events reported to the FDA between March 2013 and March 2014, as documented by the Institute for Safe Medication Practices.
This was higher than 92% of other medicines regularly checked. The report notes the “clear evidence of harm” Invokana reaches the kidneys.
When a clear evidence of harm exists, you deserve to be compensated.
Invokana manufacturer, Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has netted almost $1 billion in profits from Invokana in the last year alone. Meanwhile, the number of individuals injured by Invokana have begun to accumulate. They have begun to file consumer protection lawsuits against the pharmaceutical giant.
At the present time, The Michael Brady Lynch Firm is concentrating on Pennsylvania. This is the location where our cases are pending against the makers of Invokana. As of June 2016, approximately 41 cases were filed in Philadelphia by plaintiffs that live all across the country. This will most likely mean a mass tort consolidation at the Federal level is imminent.
When manufacturers produce unsafe products that create pain and suffering, you deserve compensation. Although no amount of money will change the fact that you have suffered a serious injury as a result of manufacturer irresponsibility, compensation will help offset your current and future medical costs, as well as provide for the pain and suffering you have experienced. By filing, you may also help protect other people and their families from needless distress.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. You may be entitled to compensation for their injuries and damages. The types of losses that can be recovered include:
If a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
If the conduct of a drug company in manufacturing and selling drug is found to be highly reckless, punitive damages may be awarded to punish the company and deter similar conduct in the future. If you developed kidney damage after taking Invokana, please speak to us to learn more about your rights.
Case evaluations are free of cost and without obligation. Call us today at (877) 513-9517 or contact us online to speak with an attorney about your options. We may be able to get you the help you need.