Patients taking the Type 2 diabetic drug Invokana or similar SGLT-2 inhibitor drugs, must learn to recognize the symptoms of kidney failure, which can be fatal if not diagnosed and treated promptly. In its first twelve months on the market, Invokana, manufactured by Johnson & Johnson and its subsidiary, Janssen, was linked to 54 cases of kidney failure and renal impairment. These cases were those which were actually reported to the FDA using the agency’s adverse event reporting system.
Invokana Kidney Failure
It is estimated that only 5-10 percent of consumers who are harmed by a drug or medical device will actually complete an adverse event report. If this holds true with Invokana injuries, there could be well over 500 cases of serious kidney failure associated with the drug. The kidneys help filter waste from the blood, and are involved in regulating blood pressure, electrolyte balance and red blood cell production. When a person’s kidneys fail, toxins, waste products, fluids and electrolytes build up in the body. A fluid imbalance occurs, and there is a disruption in the calcium and potassium balance in the blood. Some of the more common symptoms associated with kidney failure include the following:
· Edema, or swelling in the legs, ankles or feet;
· Decreased urine production (only seen in some patients);
· A metallic taste in the mouth;
· Extreme fatigue or lethargy;
· Difficulty concentrating;
· Pain in the abdomen;
· Pressure or pain in the chest region;
· Shortness of breath;
· Vomiting or nausea; and
More Risks Associated with Invokana
Should a patient’s kidney failure become permanent, he or she may have to have ongoing kidney dialysis or even a kidney transplant. Invokana has also been linked to diabetic ketoacidosis and cardiovascular events including heart attack, stroke and blood clots. An NCBI article noted Invokana could be responsible for urogenital infections, dehydration, altered renal function and arterial hypotension.
FDA Expresses Concern Regarding the Use of SGLT-2 Inhibitor Drugs
In May 2015, the FDA expressed concern regarding the risk of diabetic ketoacidosis from Invokana and other SGLT-2 inhibitor drugs. Invokana was the first SGLT-2 inhibitor drug to make it to market, followed quickly by Farxiga, Xigduo XR, Jardiance, Invokamet and Glyxambi. A group of experts is set to discuss the potential risks associated with Invokana and other SGLT-2 inhibitor drugs during an upcoming American Association of Clinical Endocrinologists conference held in Dallas on October 24th and 25th. The conference was called in response to the more than 450 adverse event reports regarding SGLT-2 inhibitor drugs.
Invokana Set to Reach Blockbuster Status in 2015
Together with Invokamet (canagliflozin combined with metformin), Invokana made more than $278 million for Johnson & Johnson in the first quarter of 2015 alone. That figure is almost triple that of the same quarter in 2014. Many in the industry expect Invokana to reach blockbuster status in 2015, reaching the $1 billion dollar mark. Invokana’s closest competitor is AstraZeneca’s Farxiga although Invokana is still comfortably in the lead as far as sales.
Invokana Drug Litigation
Lawsuits regarding injury sustained from the use of Invokana or other SGLT-2 inhibitor drugs may primarily address Johnson & Johnson’s failure to warn patients and physicians of the increases risks of kidney disease, kidney failure, myocardial infarction, diabetic ketoacidosis and other serious cardiovascular events. Myocardial infarction—also known as a heart attack—is the irreversible death of cells within the heart due to blood restriction.
Despite the fact that Johnson and Johnson and Janssen were most certainly aware of research which linked these serious health issues with the use of SGLT-2 inhibitor drugs, the manufacturers continued to market the drug and neglected to warn of serious, even deadly risks. Those who suffered injury due to taking Invokana should speak to a knowledgeable attorney to ensure their future is protected.