Invokamet is a drug prescribed for the purpose of lowering blood sugar levels in combination with diet and exercise in adults with type 1 or type 2 diabetes. It is comprised of two different drugs, Invokana (canagliflozin) and metformin and is manufactured by Janssen Pharmaceuticals, a division of Johnson & Johnson. Canagliflozin is supposed to assist the kidneys in removing glucose from the bloodstream and metformin is designed to lower glucose production in the liver and allow the intestines to absorb less glucose. The manufacturer cites a potential side benefit of incidental weight loss for patients with type 2 diabetes, as well.
In addition to the potential benefits of Invokamet, however, the drug also carries with it the risk of various side effects, many of which may result in very serious or potentially life-threatening consequences for the patient. Common side effects include urinary tract infection, yeast infection, stomach discomfort, diarrhea, frequent urination, muscle pain, shortness of breath, and nausea. The list of grave possibilities includes lactic acidosis, a buildup of lactic acid in the blood which can cause death, diabetic ketoacidosis (DKA) (an increased level of ketones in the blood), serious kidney injury, serious urinary tract infection, increased risk of heart attack, and broken bones. In particular, two of these maladies can be either very confusing and/or very difficult to detect. In the case of lactic acidosis, a number of the most common side effects cited by the manufacturer’s warnings (nausea/ vomiting, muscle pain, feeling weak or tired) may also be symptoms of this condition, leading to confusion by the patient as to whether or not they should seek emergency help. In the case of DKA, there is a particular risk that blood glucose levels may appear normal when tested, potentially resulting in delayed diagnosis or treatment.
Over the last two years, the U.S. Food and Drug Administration has issued several warnings about use of Invokamet. In September 2015, they warned that the drug might cause an increased risk of bone fractures and potentially cause a decrease in bone density. In December 2015, they warned that the drug had been linked to a number of serious side effects that might result in hospitalization or require emergency room treatment, including serious blood infections, kidney injury, diabetic ketoacidosis, urosepsis, kidney infection, and renal failure. In January 2016, the FDA mandated that Janssen make changes to their labeling indicating use of the drug may entail an increased risk of acute kidney injury. In May 2016, they warned that it may also cause an increased risk of leg, foot, or toe amputation.
Prior to the warnings, there were at least 73 confirmed cases of diabetic ketoacidosis and 19 cases of blood or kidney infection reported. Lawsuits now contend that the manufacturer, Janssen, was aware of the potential hazards and side effects of taking Invokamet prior to the issuance of these warnings by the FDA, but nevertheless failed to warn either doctors or patients. The contention is that if warned, doctors would have prescribed differently for patients with type 2 diabetes and patients would have been monitored much more closely for conditions such as signs of heart issues, renal impairment, or high ketone levels.
Thousands of lawsuits have been filed by patients who have been harmed by taking Invokamet. Many have resulted in large settlements for reimbursement of medical expenses, pain and suffering, and lost wages, or for other compensable losses available through a wrongful death claim. It is important to note, there is no class action lawsuit on this against Janssen Pharmaceuticals. Any litigation by patients adversely affected by Invokamet, must be initiated by the individual. There has also been no broad settlement from the manufacturer, as of yet. Many cases are still in litigation and can take up to several years to resolve. Nonetheless, if you have been a victim of any of these adverse and serious side effects and wish to pursue litigation, you should consult with an experienced lawyer to discuss your options.