Lawsuits are now being filed by people who were injured by side effects of Invokana, such as ketoacidosis (too much acid in the blood) and kidney failure. Janssen Pharmaceuticals is accused of downplaying these risks and knowingly selling an unsafe medication.
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 ketoacidosis or kidney failure, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
Invokana Side Effects
The most serious side effects of Invokana, according to the Prescribing Information:
- Amputations: About 7 in 1,000 patients on Invokana require a toe, foot, or leg amputation, which is twice the risk of a placebo. The label on Invokana now carries a “Black Box” warning label about the risk of amputations.
- Urinary tract infections (UTI): Occurs in about 6% of patients on Invokana, caused by bacteria that moves up the urethra and into the bladder. Urination is painful and frequent.
- Low blood pressure (hypotension): Invokana is a diuretic that gets rid of extra glucose (sugar) through the urine, which can also deplete salts and fluid levels and decrease blood pressure.
- Diabetic Ketoacidosis (DKA): Metabolic disorder in which the blood becomes too acidic due to toxic levels of ketones, which are produced when the body must burn fat for energy because it does not have enough insulin to use glucose (sugar) in the bloodstream.
- Kidney problems: Invokana relies heavily on the kidneys to excrete glucose in the urine, which can lead to renal impairment over time. Infections can also lead to kidney failure.
- Blood infections (urosepsis): Occurs when severe urinary infections spread to the bloodstream and cause sepsis, a whole-body reaction that can cause loss of consciousness, organ failure, and death.
- Kidney infections (pyelonephritis): Complication of urinary infections that spread beyond the bladder into the kidneys. Severe infections can scar the kidneys and cause chronic kidney disease, high blood pressure, and kidney failure.
- Genital yeast infections: The most common side effect of Invokana (10% of women on 100-mg dose). It occurs when Candida (yeast) is not kept in check by natural bacteria in the vagina.
- Bone fractures: Invokana can cause bone mineral density loss in the hip and lower back. It increases the risk of bone fractures (often after minor injuries, such as falling from standing height) in as little as 12 weeks.
- Increased LDL (“bad”) cholesterol: Higher doses of Invokana caused more increases in cholesterol levels.
FDA Safety Warnings for Invokana Side Effects
In May 2017, the FDA concluded that Invokana doubles a patient’s risk of lower leg, foot, and toe amputations, based on data from two large clinical trials. The agency ordered drug-makers to add a “Black Box” label to warn patients about the risk.
The FDA has issued several warnings for patients on Invokana. The first warning about ketoacidosis was issued in May 2015. In the first year Invokana was on the market, the FDA received about 20 reports of ketoacidosis.
In December 2015, the label on Invokana was updated to include ketoacidosis. The FDA also warned about life-threatening blood infections (urosepsis), kidney infections (pyelonephritis), and kidney failure that started as severe urinary tract infections from Invokana.
In September 2015, the FDA warned that Invokana can decrease bone mineral density in the hip and lower back. It can also increase the risk of bone fractures, often after minor injuries, in as little as 12 weeks.
Cardiovascular Side Effects of Invokana
Janssen Pharmaceuticals has been ordered to conduct five post-marketing studies, including a clinical trial, to investigate cardiovascular side effects like heart attack and stroke from Invokana. In clinical trials before Invokana was approved, 13 patients on Invokana had a heart attack or stroke, compared to just one patient on a placebo during the first 30 days of treatment. The risks equalized after 30 days. Invokana was also shown to increase levels of “bad” cholesterol (LDL), which is a risk-factor for cardiovascular disease.
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.