The diabetic medication Invokana has been linked to ketoacidosis, major kidney damage, severe UTI, myocardial infarction (heart attack), and stroke. Invokana use also has other known side effects that, while not life threatening, may have a major impact on your health and quality of life.
Ketoacidosis (DKA) is a serious complication of diabetes that occurs when your body produces high levels of blood acids called ketones. Ketoacidosis can result in a patient suffering a diabetic coma, extended hospitalization, and even death. Ketoacidosis develops when your body can't produce enough insulin. Insulin helps sugar (glucose) enter cells, and provides energy to the muscles and other tissues. Without enough insulin, the body breaks down fat as an alternative source of energy. This produces a buildup of acids in the bloodstream called ketones, eventually leading to diabetic ketoacidosis if untreated.
Kidney failure occurs when your kidneys stop functioning without the use of dialysis or a kidney transplant. Kidneys remove excess fluid and waste material from the blood through units called nephrons They also help control electrolyte balance, blood pressure, and red blood cell production. When your kidneys stop functioning properly, waste products, fluids, and electrolytes build up in the body and can cause weakness, shortness of breath, lethargy, confusion, abnormal heart rhythms and sudden death. Because Invokana relies so heavily on the kidneys, it poses serious risks to patients who have pre-existing kidney problems. People with late-stage diabetes who take a nephrotoxic medication could increase their risk of kidney failure.
Severe Urinary Tract Infection (UTI) can result in a nearly constant urge to urinate, but urinating can be very painful and can even give you a burning sensation. UTIs can also cause blood in the urine as well as pelvic pain, particularly for women. For a severe UTI, you may need treatment with intravenous antibiotics in a hospital.
Myocardial infarction (commonly known as a heart attack) is the death of cells within the heart caused by a restriction of blood. A portion of the heart is being starved of oxygen and nutrients, a condition called "cardiac ischemia." If this condition lasts too long, the starved heart tissue dies. It occurs when there is a blockage in the arteries preventing blood from reaching portions of the heart, and oxygen and nutrients cannot reach the heart muscle.
A Stroke is a medical emergency that occurs when blood stops folowing to the brain. Brain tissue begins to die within minutes and if the blood flow is not restored, a stroke can lead to major disabilities or death. The National Stroke Association calls a stroke a "brain attack". The Mayo Clinic recommends that you "...seek immediate medical attention if you notice any signs or symptoms of a stroke, even if they seem to fluctuate or disappear".
SGLT2 inhibitors have been linked to over 100 cases of diabetic ketoacidosis. According to a study of clinical trial data, Invokana is associated with a much higher risk of ketoacidosis than other SGLT2 inhibitors. Warnings about Invokana related ketoacidosis from have been issued by major health regulators. The FDA received 20 reports of ketoacidosis in patients on SGLT2 inhibitors and issued a Safety Communication. In June 2015, the European Medicines Agency (EMA) issued a warning after finding 101 reports of the side effect. Later that year, the FDA updated the label on Invokana to include ketoacidosis after 73 reports of patients on SGLT2 inhibitors who were hospitalized with ketoacidosis.
The FDA has issued a Safety Communication to announce new warnings for Invokana. Between March 2013 and October 2014, the FDA received 19 reports of patients on SGLT2 inhibitors who developed life-threatening complication of severe urinary tract infections, such as blood infections (urosepsis) and kidney infections (pyelonephritis). All 19 patients were hospitalized, and some needed dialysis to treat kidney failure.
In clinical trials, 13 patients on Invokana had a heart attack or stroke during the first 30 days of treatment, compared to just one patient on a placebo. Data from the CANVAS clinical trial linked Invokana to a 46% increased risk of stroke, but only in the first 30 days. When the FDA approved Invokana they asked Janssen to conduct more studies.
If you or a loved one was diagnosed with ketoacidosis or kidney failure after taking Invokana, please contact Jensen & Associates immediately for a free case evaluation. You may use the form to the right, email us at MyCase@InvokanaAdvice.com or call us toll-free at 1-800-803-3784. We can help.