A heart attack can be silent but deadly. Concerns regarding Invokana’s cardiovascular risks were reported in early clinical trial data and were discussed prior to the drug receiving FDA approval.
In January 2013, members of the FDA AdCom Panel expressed concerns about the drug’s cardiovascular risks. In the dedicated cardiovascular outcomes trial, DIA3008, CANagliflozin cardioVascular Assessment Study (CANVAS), a 4,300-subject study assessing the cardiovascular effects of Invokana, a greater number of cardiovascular events was observed during the first 30 days of treatment in canagliflozin treated people (0.45%) relative to placebo treated people (0.07%), suggesting an early period of enhanced cardiovascular risk. In this study, 13 patients taking canagliflozin suffered a major cardiovascular event (including and strokes) within the first 30 days of taking the drug, compared with 1 patient taking a placebo.
With respect to the trial cited by the FDA reviewer, the FDA concluded that “any imbalance in results during the first 30 days or the trial” in question “may be attributable to chance or may have been caused by an early increase in the risk of MACE [major adverse cardiovascular events]-plus associated with canagliflozin among subjects with high background cardiovascular risk.” The FDA went on to note that “There was no evidence of an increased risk of MACE-plus associated with canagliflozin after 30 days” in the trial.
The heart pumps blood throughout the entire body using the circulatory system. It supplies nutrients and oxygen to tissues by removing waste. The heart is about the size of a large fist and weighs between 8-12 ounces.
A heart attack occurs when one or more of coronary arteries become blocked. The most common cause of a heart attack is coronary artery disease.
Symptoms of a Heart Attack
There are signs and symptoms of a heart attack that patients should be aware of, including:
- Rapid or irregular heartbeats
- Sweating, dizziness, nausea or vomiting
- Indigestion, fullness
- Anxiety, shortness of breath
- Pressure, heaviness, pain in the chest, arm or below the breastbone
- Discomfort radiating to the back, jaw, throat, or arm
It takes about eight weeks for a heart to heal from a heart attack, but the heart’s ability to pump is lessened with each adverse cardiac event.
Always seek immediate medical attention if you believe you are suffering from a heart attack and have symptoms outlined above. If you or someone you love have suffered from a heart attack after taking the medication, Invokana, it is important that after you seek the proper medical attention, you contact an experienced national Invokana lawsuit attorney at the Chaffin Luhana, LLP law firm. Our Invokana lawyers will file a Invokana lawsuit on your behalf and this will ensure that you recover the compensation you need for rehabilitation.