Patients on Invokana are 50% more likely to experience a stroke during the first 30 days of treatment, according to clinical trials. The FDA has asked for more safety studies, but in the meantime, victims say warning information is inadequate.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Invokana induced injury cases in all 50 states. If you or somebody you know has been diagnosed with a stroke, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Invokana and Stroke
Janssen Pharmaceuticals has conducted large clinical trials to study Invokana. In the largest study, 13 patients on Invokana experienced major cardiovascular events (heart attack or stroke) in the first 30 days of treatment, but only one patient on a placebo had an event in the same time-frame. The risk equalized after 30 days.
Invokana Linked to 46% Increased Risk of Stroke
The CANVAS clinical trial involving 4,330 patients associated Invokana with a 46% increased risk of stroke, particularly in the first 30 days of treatment.
FDA Asks Janssen to Study Invokana Stroke Risk
The FDA approved Invokana in March 2013 and asked Janssen to continue studying the risk of heart attack and stroke. In the meantime, patients on Invokana who experienced cardiovascular events say Janssen did not adequately warn them about the risk.
According to the New York Times:
“The label of the drug includes no warnings about heart attacks or strokes. … The FDA is requiring Johnson & Johnson to conduct five post-marketing studies, including a clinical trial to determine more definitively if the drug increases those risks.”
Experts Warn About Risk of Blood Clots
Two months before the FDA approved Invokana, the agency met to discuss the safety of Invokana. During the question-and-answer period, a consumer advocate named Dr. Sidney Wolfe warned that Invokana might increase the risk of blood clots and “thrombotic events.”
Dr. Wolfe noted that clinical trials demonstrated elevated hematocrit levels in patients on Invokana. He said studies indicate that 25% of patients on Invokana could develop hematocrit levels of 47%, which he called “a very dangerous range.”
Hematocrit is a measure of the concentration of red blood cells. The normal level is 40% for women and 45% for men. Higher levels indicate thicker blood, which is a risk-factor for blood clots and strokes.
How Could Invokana Cause Strokes?
It is unknown if Invokana causes strokes, but there are several ways it could increase the risk. Studies show that it elevates cholesterol levels, including HDL (“good”) and LDL (“bad”) cholesterol. People with high cholesterol are much more likely to experience strokes, especially older people who also have high blood pressure.
What is a Stroke?
Invokana is associated with ischemic strokes. This type of stroke occurs when a blood clot forms in one part of the body and travels to the brain, where it blocks a blood vessel and cuts off circulation. For every minute during a stroke, 2 million brain cells (neruons) die.
Warning Signs & Symptoms
The signs of a stroke depend on where it is located and how much brain damage has occurred. The warning signs may include:
- Sleepiness or unconsciousness
- Headache
- Abnormal sensations of touch, smell, hearing, taste, pain, texture, temperature, etc.
- Confusion
- Memory loss
- Trouble writing or reading
- Dizziness
- Visual problems, blurry eyesight, double-vision, blindness
- Muscle weakness on one side of body, face, arm, or leg
- Trouble speaking or understanding speech
- Personality, mood, or emotional changes
- And more
Treatment
A stroke is a life-threatening medical emergency that must be treated in a hospital as quickly as possible. Treatments focus on dissolving the clot with medication or surgery. Patients will also be given intravenous (IV) blood-thinners, fluids, and nutrition. They will need long-term medical care for complications like paralysis, incontinence, brain damage, problems breathing or swallowing, and blindness.
Do I have a Invokana Lawsuit?
The Schmidt Firm, PLLC is currently accepting Invokana induced injury cases in all 50 states. If you or somebody you know has been diagnosed with a stroke, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.
The Schmidt Firm, PLLC has been recognized as one of the nation’s leading plaintiffs' law firms and handles cases in all 50 states. We are very proud of our legal achievements, but equally self-respecting of our firm's reputation for providing personal attention to each and every client we represent.
