Invokana, a prescription drug used to treat Type 2 diabetes gained FDA approval in March 2013. Little more than two years later, the drug is raising some serious safety questions, particularly regarding the risk of kidney failure. Janssen Pharmaceuticals—a subsidiary of Johnson & Johnson—is the manufacturer of Invokana. Invokana was the first Type 2 diabetic drug which works as an SGLT2 inhibitor to be marketed to the public. Invokana was quickly followed by Farxiga, Jardiance, Invokamet (SGLT2 inhibitors combined with Metformin), XigduoXR (SGLT2 inhibitors plus Metformin) and Glyxambi, which is the first diabetic drug to combine SGLT2 inhibitors along with DPP-4 inhibitors.
Invokana Expected to Reach Blockbuster Status in 2015
Invokana has become a significant money-maker for Johnson and Johnson and Janssen Pharmaceuticals. In the first quarter of 2015, Invokana brought in more than $278 million—triple what it made in 2014. Industry experts expect Invokana to reach “blockbuster” status during 2015, which means it will pass the $1 billion mark in sales. Perhaps because it was the first SGLT2 drug on the market, Invokana is financially exceeding all other SGLT2 drugs by significant margins.
SGLT2 (sodium-glucose co-transporter-2) inhibitors lower the blood sugar in a person with Type 2 diabetes by blocking reabsorption of glucose by the kidneys and increasing the excretion of glucose in the urine. Recent findings suggest SGLT2 may also increase the production of glucose by stimulating the secretion of glucagon which is used to increase blood glucose levels in a person with severe hypoglycemia.
Kidney Damage and Kidney Failure Caused by SGLT2 Inhibitors
One of the more serious complications linked to the use of Invokana is renal failure, which affects more than 100,000 people across the United States each year. Nearly half of these cases of kidney failure occur in those who have diabetes, as the kidneys are no longer able to do their job of filtering waste from the bloodstream. Kidney failure can be the result of a serious diabetic attack, and it appears that, by stimulating the secretion of glucagon, Invokana may significantly increase the risk of kidney damage or kidney failure. In fact, in May, 2015, the FDA warned that Invokana and other SGLT2 inhibitors, could lead to diabetic ketoacidosis, which, if not properly diagnosed and promptly treated, can subsequently lead to kidney failure. Some of the symptoms of kidney failure those taking Invokana should be aware of include:
· Changes in urination;
· Unusual levels of fatigue;
· Decreased appetite;
· Changes in mood;
· A metallic taste in the mouth;
· Pain between the ribs and the hip area;
· An increase in blood pressure;
· Lessened sensation in the extremities;
· Vomiting, nausea or bloody stools;
· Prolonged bleeding, including a nosebleed which won’t stop;
· Swollen ankles, legs and feet;
· Difficulty breathing, and
· Slow, sluggish movements
Johnson & Johnson’s Failure to Warn
Many experts believe the link between Invokana and kidney failure was known—or should have been known or suspected—before the drug was introduced to the public. Since Invokana essentially works by blocking the function of the kidneys, it is not such a leap to believe that this process could damage normal kidney functions. The elderly, particularly those over the age of 75, as well as patients with a prior history of kidney problems, are those most likely to experience kidney failure and kidney damage from Invokana.
Many believe the benefits provided for patients taking Invokana simply don’t outweigh the potential risks. In addition to kidney damage and kidney failure, Invokana has also been linked to heart attack, bone fractures stroke and potentially deadly ketoacidosis. Even though the FDA approved Invokana, a third of the panel advised against approving the drug due to concerns that the drug could be dangerous for those with undiagnosed kidney disease. Taking all these facts together, believing Johnson & Johnson exhibited a blatant failure to warn is not much of a stretch.