Side effects of the diabetes medication Invokana may include heart attack, according to the U.S. Food & Drug Administration (FDA).
Free Confidential Lawsuit Evaluation: If you or a loved one had a heart attack after taking Invokana, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturers and our lawyers can help.
Update: Invokana Linked to Heart Attack Risk in Post-Marketing Studies
March 25, 2016 - Results of post-marketing studies performed on the type 2 diabetes drug Invokana (generic: canagliflozin) identified a significantly increased risk of heart attack in patients who took the medication during their first 30 days of treatment.
During the trials, several Invokana users suddenly developed heart attacks or strokes within the first 30 days of treatment. After the 30-day period passed, the risk factors suddenly and inexplicably leveled out. The study’s authors were unable to determine exactly why this occurred, although it is well understood that diabetes medications can increase patients’ cholesterol levels, which can lead to heart problems.
Despite the fact that the U.S. Food & Drug Administration (FDA) recently issued a public safety warning regarding Invokana, and has required manufacturer Janssen Pharmaceuticals to update the medicine’s warning label, the agency has made no mention of the heart attack risk associated with the drug.
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.”
While the complete results from these trials have yet to be published, medical professionals are asking that all patients taking Invokana or other SGLT2 inhibitor diabetes drugs watch for symptoms of an impending heart attack. Invokana users are also asked to remain extra cautious while looking for symptoms during the first 30 days of treatment, due to the study results which highlighted this as a particularly high-risk time. Patients experiencing any of these symptoms should contact their doctor immediately.
Early Warnings about Invokana Cardiovascular Risks
Much of the bad press surrounding Invokana (generic: canagliflozin) has to do with ketoacidosis -- also known as DKA, diabetic acidosis or simply ketoacidosis -- a life-threatening condition that can cause raise blood acids. However, there is another problem with the drug, and there is evidence that both the manufacturer and the FDA knew about it before it hit the market. This issue is the risk of heart attack linked to Invokana.
At a Jan. 2013 meeting of the FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDA), representatives from Janssen Pharmaceuticals gave presentations on the growth of type 2 diabetes in America, the need for new medicines to combat the disease, and the benefits of its latest product, Invokana. During the question-and-answer session that followed, co-founder and director of Public Citizen's Health Research Group Dr. Sidney Wolfe raised some questions:
“As with all recently approved Type 2 diabetic drugs, [there is] no evidence of any improved clinical outcomes, contrary to an older diabetes drug such as metformin,” Wolfe said. “This surrogate efficacy needs to be balanced against a number of serious safety signals identified in the clinical trials.”
Wolfe’s most pressing concern was “thrombotic events,” or blood clots that could cause heart attacks. He noted that in the studies presented by Janssen, 13 patients treated with Invokana suffered “cardiovascular events.” Taking data from a type 2 diabetes medication in the same class, Farxiga (generic: dapagliflozin), Wolfe demonstrated that the heart attack risk for Invokana users would be significantly greater: “there is much more of an increase in hematocrit in the people getting canagliflozin [Invokana], 1.5 times as much as the dapa [gliflozin] group,” he said.
Hematocrit is the concentration of red blood cells, which is increased by gliflozin’s mechanism of action. Normal concentration is 40% for women and 45% for men; levels greater than this increases the risk of a blood clot leading to a heart attack or stroke. According to Wolfe, at least 25% of Invokana users would develop a red blood cell concentration of 47% - which he characterized as “a very dangerous range.”
Another FDA Reviewer, Dr. Hyon Kwon, testified at the hearing about “an imbalance in early cardiovascular events” observed in the CANVAS trial, which looked at the cardiovascular effects of Invokana. When FDA Biostatistician Dr. Mat Soukop testified, it became apparent how staggering the disparity is. Soukop reported that over the first 30 days of use, Invokana had a cardiovascular events “Hazard Ratio” of 6.9; that is, patients treated with the drug had a 690% increased risk of having a cardiovascular event compared to individuals who received a placebo.
Considering Wolfe's expert testimony along with the FDA’s own analysis, we would assume that additional studies would be needed before Invokana could be approved. However, the FDA cleared Invokana for sale in the U.S. on the condition that Janssen monitor adverse events related to the drug. Janssen was also ordered to conduct a “post-market" double-blind study in order to determine how many patients actually experienced heart attacks on Invokana – and gave the company 4 years to complete it.
What Happens During a Heart Attack?
The heart muscle requires a steady supply of oxygenated (red) blood from the coronary arteries to nourish it. In patients with heart disease, the coronary arteries are narrow and blood cannot flow efficiently through them. Fatty matter, calcium, proteins and inflammatory cells accumulate in the arteries to form plaques.
When these plaques are hard, the outer shell cracks, blood platelets rush to the area, and blood clots form around the plaque. If a clot completely blocks the artery, the heart muscle becomes "starved" for oxygen. Within a short time, death of heart muscle cells occurs, causing permanent damage. This is a heart attack.
Heart Attack Symptoms
Signs of a heart attack may include:
- Chest pain / discomfort
- Shortness of breath
- Cold sweats
- Unusual fatigue
- Nausea / vomiting
- Light-headedness / sudden dizziness
- Any sudden, new symptoms or a change in the pattern of symptoms you already have
Prompt and efficient treatment for a heart attack can prevent or limit damage to the heart muscle. Acting fast can save your life. Medical personnel can begin diagnosis and treatment even before you get to the hospital.
Once a heart attack is diagnosed, treatment involves restoring blood flow to the heart. The 2 main treatments are "clot-busting" drugs and percutaneous coronary intervention (PCI), a procedure used to open blocked coronary arteries.
Invokana Side Effects
In addition to being linked to heart attack, other serious side effects of Invokana may include:
- Diabetic Ketoacidosis (DKA)
- Kidney Failure (Renal Failure)
- Kidney Cancer
- Kidney Infections (Pyelonephritis)
- Kidney Stones
- Bone Fractures
- Bone Abnormalities
- Testicular Cancer
- Urinary Tract Infections (UTIs)
- Severe Dehydration / Fluid Imbalance
- Abnormal Weight Loss
- Hypersensitivity (Allergic Response)
- Blood Infections (Urosepsis)
- Fungal Infections
Do I Have an Invokana Heart Attack Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Invokana lawsuits. We are handling individual litigation nationwide and currently accepting new heart attack cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one was injured by Invokana side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a class action suit and our lawyers can help.