Invokana Injuries Lawyer Washington DC
The medication Canagliflozin, sold under the brand name Invokana among others, is used to treat type 2 diabetes. The medication is intended to be used along with exercise and a healthy diet, but not recommended in type 1 diabetes. Invokana belongs to a class of drugs that are sodium-glucose cotransporter-2 (SGLT2) inhibitors, which lower blood sugar levels in type 2 diabetes patients, but unfortunately, SGLT2 inhibitors have been linked to dangerous side effects, including diabetic ketoacidosis (DKA), characterized by excessive acid levels in the blood that cause the blood to become overly acidic, kidney injuries and bone fractures.
The American Diabetes Association has said the symptoms of ketoacidosis include trouble breathing, nausea, vomiting, abdominal pain, confusion or difficulty concentrating, unusual fatigue or sleep and dry or flushed skin
The Food and Drug Administration’s adverse event data also links Invokana and similar drugs to possible impaired kidney function. Adverse renal functions associated with these drugs include kidney failure, kidney impairment, dehydration/fluid imbalances, kidney stones, urinary tract infections, and abnormal weight loss.
Prior to being approved by the FDA, Invokana was hotly debated by FDA panel members about the drug’s cardiovascular safety. One clinical study brought up showed 13 cardiovascular (CV) events in the Invokana group. In the placebo group, there was just one CV event. Eight of the 15 panel members expressed concerns over possible CV events, noting their reservations of “unresolved questions” over increased incidence of stroke and other events.
During a 2013 Congressional testimony, Dr. Sydney Wolfe, speaking on behalf of a prominent consumer watchdog group, argued that the risks of Invokana outweighed its benefits. Dr. Wolfe strongly argued said that the drug should not be approved by the FDA. But approved it was.
Since getting approved by the FDA, safety groups argued that there has not been enough clinical trials to accurately assess the drug’s side effects. Invokana and SGLT2 inhibitors have also been linked to breast and bladder cancer, pancreatitis, yeast infections and bone fractures.
In May 2015, the FDA warned that SGLT2 inhibitors may lead to ketoacidosis. The FDA reviewed dozens of adverse event reports from patients who required hospitalization after taking the drugs. In September 2015, the FDA revised Invokana and Invokamet’s labels to include a bone fracture risk and decreased bone mineral density warning.
In June 2016, the FDA introduced new kidney warnings for SGLT2 drugs Invokana, Invokamet, Farxiga, and Xigduo XR. The warnings stated that the drugs were linked to adverse event reports of acute kidney injury, which included decreased urine and swelling in the legs or feet, which could lead to amputation. The warning was based on more than 100 adverse event reports submitted to the FDA. At the time, the agency noted that renal side effects are likely underreported and may be more common than records indicate.
In May 2017, the FDA ordered the highest warning it can issue, called a black box warning, for Invokana’s increased risk of foot and leg amputations. The warning followed results of two clinical trials which showed that patients with type 2 diabetes were two times more likely to need a toe, foot or leg amputation if they took Invokana than if they took a placebo. According to the FDA, amputations of the toe and foot were most common, but leg amputations above and below the knee did occur.
Hundreds of patients filed lawsuits against Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) and other drug manufacturers. The lawsuits claim patients were not sufficiently warned about SGLT2 inhibitor side effects that caused renal failure.
If you or a loved one is a Diabetes patient that has experienced serious side effects from taking Invokana or other SGLT2 inhibitors, our Invokana Injuries Lawyer Washington DC legal team may be able to help. You or your loved one may be entitled to lawsuit compensation for medical bills, lost wages, pain and suffering, and funeral costs (in case of death as a result of the side effect.)
If you are in the DC area and are looking to file a lawsuit for any damages stemming from the side effects of Invokana or other SGLT2 inhibitors, you can reach us at a 24/7 live phone answering. So, if you need a DC lawyer who handles injury lawsuits contact Cohen & Cohen, call our DC Law Firm today.
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Invokana Injuries Lawyer Washington DC