The diabetes drug Invokana was linked to a 50% increased risk of stroke in the first 30 days of treatment during clinical trials. Although no one knows if Invokana causes strokes, Janssen is accused of downplaying this risk information.
Need a Texas Invokana Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with a stroke, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
Invokana and Stroke
Janssen Pharmaceuticals gained approval for Invokana in March 2013 based on several studies. In clinical trials, 13 patients on Invokana suffered a major heart attack or stroke within the first 30 days of treatment. Only one patient on a placebo had a cardiovascular event in the same time-frame. After 30 days, the risk equalized.
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.”
Invokana Linked to 46% Increased Risk of Stroke
Data from the CANVAS clinical trial suggests that Invokana is not associated with an increased risk of cardiovascular events, but there was a 46% increased risk of stroke, particularly in the first 30 days of treatment.
Experts Raise Concerns About Blood Clots
In January 2013, the FDA met to discuss the safety of Invokana. During the question-and-answer period, Dr. Sidney Wolfe raised concerns about blood clots that could cause “thrombotic events.”
He cited clinical trials found abnormal increases in hematocrit, which is the concentration of red blood cells. As the blood thickens, patients are more likely to develop blood clots, heart attack, and strokes.
Normal hematocrit concentration is 40% for women and 45% for men. According to Dr. Wolfe, about 25% of Invokana users could develop hematocrit concentrations of 47% — which he called “a very dangerous range.”
Does Invokana Cause Strokes?
No one knows if Invokana causes strokes, but there are many ways it could potentially increase the risk. Invokana is known to elevate cholesterol levels, including “bad” (LDL) and “good” (HDL) cholesterol. High cholesterol is a risk-factor for cardiovascular events. Strokes are also more likely when the blood is thickened.
What is a Stroke?
A stroke occurs when blood-flow to part of the brain is cut off. About 2 million brain cells (neurons) die during every minute of a stroke. Most strokes are caused by bleeding in the brain (hemorrhagic stroke) or a blood clot that blocks blood vessels supplying blood to the brain (ischemic stroke). Invokana is associated with ischemic strokes and blood clots that could also cause heart attacks.
The severity of a stroke depends on where it occurs in the brain and how much the brain is damaged. Symptoms may include:
- Changes in alertness (sleepiness, unconsciousness, etc.)
- Changes in sensation (hearing, taste, touch, pain, pressure, temperature, etc.)
- Confusion or memory loss
- Trouble swallowing
- Problems writing or reading
- Eyesight problems (blurry vision, double-vision, blindness)
- Loss of balance or coordination
- Muscle weakness in the face, arm, or leg (usually on one side)
- Problems speaking or understanding speech
- Changes in personality, mood, or emotions
A stroke is a medical emergency that must be treated immediately. In the hospital, patients will receive medications that dissolve blood clots. They may also need to undergo surgery to relieve the symptoms. Most patients are given intravenous (IV) blood-thinners, fluids, and nutrition. Treatment becomes much more complex when patients have permanent brain damage, breathing problems, paralysis, incontinence, or trouble swallowing.
Need an Invokana Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Invokana lawyers for a free lawsuit review.