When Johnson & Johnson released a new type 2 diabetes medication called Invokana, the press was effusive with praise for the “groundbreaking” drug. Medical professionals and the healthcare industry at large had high expectations for Invokana, anticipating that it could usher in a new wave of more effective treatment plans for type 2 diabetes. Meanwhile, financial experts speculated with excitement that healthcare investors could profit handsomely from Invokana.
But now, Johnson & Johnson is being accused of “downplaying the seriousness” of Invokana side effects, after the FDA sent out a major 2015 safety warning that says Invokana may put patients at risk for ketoacidosis—a chemical imbalance that can land patients in the emergency room, or worse.
FDA Says Taking Invokana Or Related Medications Could Result In Ketoacidosis
After receiving a number of complaints from Invokana patients hospitalized for ketoacidosis, a “serious condition” in which the body is overwhelmed by high blood acid levels, the U.S. Food and Drug Administration issued an urgent safety communication.
Dated May 15, 2015, this alert was directed to prescribing doctors and patients taking any medications containing sodium-glucose co-transporter2 (SGLT2) inhibitors, drug agents that flush out sugar via the urine to lower blood glucose levels. In addition to Invokana, the FDA-approved drugs Invokamet, Farxiga, and Jardiance employ SGLT2 inhibitors.
The FDA instructed patients to carefully monitor themselves for ketoacidosis symptoms such as:
- Blurry vision
- Abdominal pain
- Constant fatigue
- Nausea or vomiting
- Labored breathing
- Frequent urination
- High blood glucose levels
- Dry mouth or abnormal thirst
- Flushed or unnaturally dry skin
- Sweet-smelling breath or urine (ketone bodies tend to smell fruity)
According to the FDA, Invokana patients suffering from one or more of these symptoms should seek “immediate medical attention.”
Also, doctors were asked to conduct acidosis testing in cases of suspected ketoacidosis and to discontinue SGLT2 inhibitor prescriptions if the condition is confirmed. Intent on continued monitoring of patient reactions to Invokana, the FDA strongly encouraged both doctors and patients to submit reports of ketoacidosis or any other side effects encountered.
A Closer Look At Ketoacidosis And Invokana
Why did the FDA find patient reports of Invokana ketoacidosis so alarming? To gain a better understanding, it’s helpful to consider some basic facts about how ketoacidosis occurs and the complications it can lead to.
What Causes Ketoacidosis?
Ketoacidosis is a condition characterized by elevated blood acidity. This acidity originates from the release of “ketone bodies,” byproducts of fat metabolism.
Normally, the body depends primarily on glucose for energy. But when no glucose is available or the body is unable to utilize it for some reason, stored fat can serve as a backup fuel source. However, relying on fat for energy over extended periods causes blood acidity to rise, as acidic ketone bodies produced from the breakdown of fat accumulate.
The body can be constantly driven to turn to fat instead of glucose, potentially leading to ketoacidosis, when a patient suffers from:
- Starvation. Whether due to intentional fasting or to economic necessity, a lack of food causes the body to halt the production of insulin, the hormone which enables glucose to move from the bloodstream into cells. A lack of insulin is one condition that helps initiate fat-burning pathways.
- Alcohol Abuse. Alcohol in the blood is another known trigger for fat metabolism. Furthermore, many patients with alcohol addiction tend to replace meals with alcohol consumption, causing low-level starvation.
- Type 1 Diabetes. Patients who have type 1 diabetes cannot produce insulin, so their bodies will always produce energy via fat metabolism unless they constantly inject themselves with insulin. Ketoacidosis caused by type 1 diabetes is termed DKA (Diabetic Ketoacidosis) and is so common that it’s considered a major symptom / complication of the disease.
You can learn more about DKA from the American Diabetes Association.
It Is Rare In Type 2 Diabetes
Since patients with type 1 diabetes suffer from a lack of insulin, which triggers fat metabolism, they are in constant danger of developing ketoacidosis unless their diabetes is well-controlled. On the other hand, in type 2 diabetes, cells are resistant to the insulin, leaving them unable to properly utilize glucose, but insulin levels are usually normal. Thus, patients with type 2 diabetes rarely experience ketoacidosis.
Though the FDA wouldn’t see anything strange about reports of ketoacidosis from type 1 diabetics, the agency immediately knew something was wrong with the influx of ketoacidosis reports from patients taking Invokana and other SGLT2 inhibitors, which are only used to treat type 2 diabetes.
Further analysis of the patients who experienced ketoacidosis showed that they did not exhibit the high blood glucose readings that typically accompany the condition—another abnormal circumstance that suggested to the FDA that these ketoacidosis cases may have somehow been caused by SGLT2 inhibitor side effects.
The FDA likely also felt that the ketoacidosis reports warranted a major safety alert because of the dangerous complications that can arise from ketoacidosis.
Heightened blood acidity wreaks havoc on the body by depriving it of the normal chemical balance required for optimal organ function. It also causes considerable fluid loss via vomiting and urination, which can lead to severe dehydration. If unchecked, dehydration can result in coma or even death.
This is how ketoacidosis can progress into a medical emergency requiring hospitalization. To quickly curb the dehydration, the patient is given an infusion of fluids and electrolytes. Meanwhile, the root cause of ketoacidosis is eliminated by administering insulin, providing cells with glucose so that they can stop the fat metabolism that creates ketone bodies. Unfortunately, this standard treatment is often accompanied by complications of its own:
- Hypokalemia. Low blood potassium levels that may result after administering insulin and fluids intravenously. Symptoms include unstable glucose levels, cramping or pain in the muscles, hallucinations, and other psychological ailments such as depression.
- Hypoglycemia, or low blood sugar, occurs if intravenous insulin causes too much glucose to enter cells at a time. Extended periods of hypoglycemia can lead to seizures and permanent neural damage.
- Cerebral edema. If blood glucose decreases too quickly, the brain may swell up. If the swelling is escalated to the point where the brain comes up against the skull, the patient may die from a lack of blood flow.
Victims Are Filing Lawsuits
As we’ve seen, ketoacidosis can render a patient incapacitated or even dead. At the very least, the condition can leave patients struggling with medical expenses and lost wages after suffering the complications. This is why patients across the country have already filed lawsuits against Janssen Pharmaceuticals, Invokana’s manufacturer.
The personal injury attorneys at Banville Law are now offering free case evaluations to any patients who may have been harmed by a prescription of Invokana or another SGLT2 inhibitor medication. The statute of limitations for cases such as these can be very difficult to navigate in New York so it is important that you work with experienced lawyers familiar with New York’s legal system. Contact us today–we’re here to help.